Venous ThrombosisNCT02567903
Tourniquet Study: A Clinical Trial Into the Effect of Tourniquet Use on the Coagulation System
A study testing Thigh Tourniquet and Knee arthroscopy in people with Venous Thrombosis, run by Groene Hart Ziekenhuis at 1 site in Netherlands.
Trial summary
Knee arthroscopy is the most commonly performed orthopaedic procedure worldwide, with, according to the American Society for Sports Medicine, over 4 million procedures performed each year. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thrombosis
- What is being tested?
- Thigh Tourniquet and Knee arthroscopy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2015to Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meniscectomy
- Diagnostic arthroscopy
- Removal of corpora libera
Who cannot join
- Any kind of coagulation disorder
- pregnant or within 3 months of childbirth
- Use of hormonal anticonception
- A history of venous thrombosis
- Had major surgery in the past two months
- A history of cast-immobilization of the lower extremity the past two months
Show all 10Show fewer
- A neoplasm or inflammatory disease
- A BMI>30
- using anticoagulant therapy
- Any other anaesthesia technique than spinal anaesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tourniquet Study: Is the High Thrombosis Risk After Knee Arthroscopy Caused by Limb-tourniquet Application? A Randomized Clinical Trial Into the Effect of Tourniquet Use on the Coagulation System
Knee arthroscopy is the most commonly performed orthopaedic procedure worldwide, with, according to the American Society for Sports Medicine, over 4 million procedures performed each year. The risk of venous thrombosis following this procedure is considerable with rates of symptomatic events varying between 0.9% and 4.6%. It is currently unknown how this high risk comes about considering its short duration and minimal tissue damage caused by the procedure. A factor that may play a role is the use of a tourniquet. A large majority of orthopaedic surgeons prefer to operate within a 'dry field', which is obtained by the use of a tourniquet. Tourniquet applied surgery is not without risks. Although its use during orthopedic surgery is widely accepted and a standard procedure, tourniquet use can lead to loss of muscle functional strength and contractile speed, vessel wall damage and nerve injury, next to the possibly increased risk of venous thrombosis. In the proposed study the investigators will investigate the effect of a tourniquet on local and systemic markers of hypoxia, inflammation, involvement of endothelium, and coagulation activation. A finding of more prominent activation of the coagulation system with tourniquet use than with non-use will create an important opportunity to prevent thromboembolic events in these patients, as it has been shown that knee arthroscopy can be performed adequately without the use of a tourniquet. Furthermore, it will increase the understanding of the pathophysiology of thrombosis.
Read the detailed description
Background
Knee arthroscopy is the most commonly performed orthopaedic procedure worldwide, with, according to the American Society for Sports Medicine, over 4 million procedures performed each year. The risk of venous thrombosis following this procedure is considerable with rates of symptomatic events varying between 0.9% and 4.6%.
It is currently unknown how this high risk comes about considering its short duration and minimal tissue damage caused by the procedure. A factor that may play a role is the use of a tourniquet. A large majority of orthopaedic surgeons prefer to operate within a 'dry field', which is obtained by the use of a tourniquet. In the proposed study the investigators will investigate the effect of a tourniquet on local and systemic markers of hypoxia, inflammation, involvement of endothelium, and coagulation activation.
Objective
To investigate the effect of tourniquet application on the coagulation system in patients undergoing a knee arthroscopy. A finding of more prominent activation of the coagulation system with tourniquet use than with non-use will create an important opportunity to prevent thromboembolic events in these patients, as it has been shown that knee arthroscopy can be performed adequately without the use of a tourniquet. Furthermore, it will increase the understanding of the pathophysiology of thrombosis.
Study Design
In a randomized, controlled clinical study the investigators will compare local and systemic coagulation and inflammation markers before and after knee arthroscopy between two groups: 25 patients will be randomized to arthroscopy with tourniquet (Group I) and 25 patients to arthroscopy without tourniquet (Group II).
Inclusion and exclusion criteria
The patients will be recruited from one hospital in Gouda over a 6 months inclusion period. All patients over 18 years, scheduled for a meniscectomy, diagnostic arthroscopy or removal of corpora libera will be eligible for inclusion. Patients will be excluded when they suffer from any kind of coagulation disorder, use of hormonal anticonception, in case of pregnancy or puerperium, when they have a history of venous thrombosis, had major surgery or cast-immobilisation of the lower extremity in the past two months, have a neoplasm or inflammatory disease, have a BMI>30, or when they use anticoagulant therapy. Patients will generally receive spinal anaesthesia. Patients who are nevertheless exposed to any other type of anaesthesia will be excluded as well, to keep the effect of anaesthesia equal for all participants.
Intervention
Patients will be randomized to knee arthroscopy without tourniquet use and to knee arthroscopy with tourniquet use. In patients randomized to arthroscopy with tourniquet use, exsanguination in the leg in which the knee arthroscopy will be performed will be accomplished by raising the leg vertically for one minute. The tourniquet will be inflated to 100-150 mmHg above systolic blood pressure.
Data on duration of surgery and duration of tourniquet use will be collected. Blood collected from the cubital vein and the great saphenous vein during arthroscopy of the knee will be analyzed on outcome parameters that reflect a hypoxic state, an inflammatory reaction, involvement of the endothelium, a procoagulant state and thrombin formation.
Main study endpoints (primary)
Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery will be analyzed.
Different patterns will be analyzed to explore the effect of tourniquet application on the coagulation system by possible biological mechanism. A change (increase or decrease) of markers within one pattern, compared to baseline measurements (before surgery), is considered as a relevant shift of that pattern, thereby suggesting the involvement of that specific pathway.
Outcome parameters that reflect a hypoxic state:
- pH
- pO2
- pCO2
- Lactate
Outcome parameters that reflect an inflammatory reaction:
- White Blood Cell Count (WBCC)
- E-selectin
- Neutrophil Extracellular traps (NETs)
Outcome parameters that reflect involvement of the endothelium:
- Von Willebrand Factor (vWF)
- Thrombomodulin
- E-selectin
Outcome parameters that reflect a procoagulant state and thrombin formation:
- Prothrombin fragments 1+2
- D-dimer
- Plasmin Activator Inhibitor 1 (PAI 1)
- Tissue plasminogen activator (tPA)
- Factor VIII
- Thrombin and Antithrombin complexes (TAT)
- Plasmin and antiplasmin complexes (PAP)
Secondary study paramaters
- Visibility during arthroscopy and technical difficulty score.
Time Schedule
Month 1-3: Completion of study protocol, procedure for approval by METC. Set up of database and randomisation procedure. Instruction of participating clinicians and surgery/anaesthesia staff.
Month 4-6: Inclusion of patients, data collection. Month 7-8: Laboratory tests. Month 9-12: Data analysis, writing and submission of manuscript.
- Conditions
- Venous Thrombosis
- Being tested
- Thigh Tourniquet, Knee arthroscopy
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thigh TourniquetDevice
Knee arthroscopy with the use of a thigh tourniquet that is inflated to 100-150 mmHg above systolic blood pressure.
Knee arthroscopyProcedure or surgery
Knee arthroscopy
| Study group | Role | What they receive |
|---|---|---|
| No Tourniquet | Active comparator | Knee arthroscopy without the use of a thigh tourniquet. Receives: Procedure: Knee arthroscopy |
| Tourniquet | Experimental | Knee arthroscopy with the use of a thigh tourniquet. Receives: Device: Thigh Tourniquet; Procedure: Knee arthroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in parameters that reflect a hypoxic state assessed by pH
Change in pH between timepoints
Measured: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery.
Change in parameters that reflect a hypoxic state assessed by pO2
Change in pO2 between timepoints
Measured: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery.
Change in parameters that reflect a hypoxic state assessed by pCO2
Change in pCO2 between timepoints
Measured: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery.
Change in parameters that reflect a hypoxic state assessed by Lactate
Change in Lactate between timepoints
Measured: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery.
Change in parameters that reflect an inflammatory reaction assessed by WBCC
Change in White Blood Cell Count (WBCC) between timepoints
Measured: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery.
Change in parameters that reflect an inflammatory reaction and/or endothelium involvement assessed by E-selectin
Change in E-selectin between timepoints
Measured: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery.
Change in parameters that reflect an inflammatory reaction assessed by NETs
Change in Neutrophil Extracellular traps (NETs) between timepoints
Measured: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery.
Outcome parameters that reflect involvement of the endothelium assessed by vWF
Change in Von Willebrand Factor (vWF) between timepoints
Measured: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery.
Outcome parameters that reflect involvement of the endothelium assessed by thrombomodulin.
Change in Thrombomodulin between timepoints
Measured: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery.
Outcome parameters that reflect involvement of the endothelium assessed by f 1+2
Change in Prothrombin fragments 1+2 (f 1+2) between timepoints
Measured: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery.
Outcome parameters that reflect a procoagulant state and thrombin formation assessed by D-dimer
Change in D-dimer between timepoints
Measured: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery.
Outcome parameters that reflect a procoagulant state and thrombin formation assessed by PAI 1
Change in Plasmin Activator Inhibitor 1 (PAI 1) between timepoints
Measured: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery.
Outcome parameters that reflect a procoagulant state and thrombin formation assessed by tPA
Change in Tissue plasminogen activator (tPA) between timepoints
Measured: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery.
Outcome parameters that reflect a procoagulant state and thrombin formation assessed by factor VIII
Change in Factor VIII between timepoints
Measured: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery.
Outcome parameters that reflect a procoagulant state and thrombin formation assessed by TAT
Change in Thrombin and Antithrombin complexes (TAT) between timepoints
Measured: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery.
Outcome parameters that reflect a procoagulant state and thrombin formation assessed by PAP
Change in Plasmin and antiplasmin complexes (PAP) between timepoints
Measured: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery.
Secondary outcomes (3)
Duration of surgery
The total duration of surgery in minutes
Measured: intraoperative, duration in minutes between first incision until closure
Duration of tourniquet use
The total duration of tourniquet inflation in minutes
Measured: intraoperative, duration in minutes between tourniquet inflation and deflation
Per-operative visibility
Visibility during surgery, measured on a Visual Analogue Scale scale (0-10)
Measured: Per-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2015 (estimated)
- Study startSep 2015
- Primary completionJun 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Venous ThrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groene Hart Ziekenhuis
- Sponsor type
- University, hospital or other
- Collaborators
- Leiden University Medical Center
- Responsible party
- Principal investigator, Ron Onstenk, Groene Hart Ziekenhuis
- Investigators
- Suzanne C Cannegieter, MD, PhD, Study chair, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02567903
- Sponsor's protocol ID
- NL49117.058.14
- Status last verified
- Feb 2020
- First submitted
- 21 Sep 2015
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
American Academy of Orthopaedic Surgeons. Knee Arthroscopy. 2013. http://orthoinfo.aaos.org/topic.cfm?topic=a00299. Accessed April 15, 2014
Geerts WH, Bergqvist D, Pineo GF, Heit JA, Samama CM, Lassen MR, Colwell CW. Prevention of venous thromboembolism: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008 Jun;133(6 Suppl):381S-453S. doi: 10.1378/chest.08-0656.
PubMed 18574271Hoppener MR, Ettema HB, Kraaijenhagen RA, Verheyen CC, Henny PC. Day-care or short-stay surgery and venous thromboembolism. J Thromb Haemost. 2003 Apr;1(4):863-5. doi: 10.1046/j.1538-7836.2003.t01-9-00115.x. No abstract available.
PubMed 12871434Hoppener MR, Ettema HB, Henny CP, Verheyen CC, Buller HB. Symptomatic deep vein thrombosis and immobilization after day-care arthroscopy of the knee. J Thromb Haemost. 2005 Jan;3(1):185-7. doi: 10.1111/j.1538-7836.2004.01091.x. No abstract available.
PubMed 15634289Hoppener MR, Ettema HB, Henny CP, Verheyen CC, Buller HR. Low incidence of deep vein thrombosis after knee arthroscopy without thromboprophylaxis: a prospective cohort study of 335 patients. Acta Orthop. 2006 Oct;77(5):767-71. doi: 10.1080/17453670610012962.
PubMed 17068708Camporese G, Bernardi E, Prandoni P, Noventa F, Verlato F, Simioni P, Ntita K, Salmistraro G, Frangos C, Rossi F, Cordova R, Franz F, Zucchetta P, Kontothanassis D, Andreozzi GM; KANT (Knee Arthroscopy Nadroparin Thromboprophylaxis) Study Group. Low-molecular-weight heparin versus compression stockings for thromboprophylaxis after knee arthroscopy: a randomized trial. Ann Intern Med. 2008 Jul 15;149(2):73-82. doi: 10.7326/0003-4819-149-2-200807150-00003.
PubMed 18626046Ilahi OA, Reddy J, Ahmad I. Deep venous thrombosis after knee arthroscopy: a meta-analysis. Arthroscopy. 2005 Jun;21(6):727-30. doi: 10.1016/j.arthro.2005.03.007.
PubMed 15944631Ramos J, Perrotta C, Badariotti G, Berenstein G. Interventions for preventing venous thromboembolism in adults undergoing knee arthroscopy. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD005259. doi: 10.1002/14651858.CD005259.pub3.
PubMed 18843687Bovill EG, van der Vliet A. Venous valvular stasis-associated hypoxia and thrombosis: what is the link? Annu Rev Physiol. 2011;73:527-45. doi: 10.1146/annurev-physiol-012110-142305.
PubMed 21034220Aglietti P, Baldini A, Vena LM, Abbate R, Fedi S, Falciani M. Effect of tourniquet use on activation of coagulation in total knee replacement. Clin Orthop Relat Res. 2000 Feb;(371):169-77. doi: 10.1097/00003086-200002000-00021.
PubMed 10693564Katsumata S, Nagashima M, Kato K, Tachihara A, Wauke K, Saito S, Jin E, Kawanami O, Ogawa R, Yoshino S. Changes in coagulation-fibrinolysis marker and neutrophil elastase following the use of tourniquet during total knee arthroplasty and the influence of neutrophil elastase on thromboembolism. Acta Anaesthesiol Scand. 2005 Apr;49(4):510-6. doi: 10.1111/j.1399-6576.2005.00621.x.
PubMed 15777299Kageyama K, Nakajima Y, Shibasaki M, Hashimoto S, Mizobe T. Increased platelet, leukocyte, and endothelial cell activity are associated with increased coagulability in patients after total knee arthroplasty. J Thromb Haemost. 2007 Apr;5(4):738-45. doi: 10.1111/j.1538-7836.2007.02443.x.
PubMed 17408407Reikeras O, Clementsen T. Time course of thrombosis and fibrinolysis in total knee arthroplasty with tourniquet application. Local versus systemic activations. J Thromb Thrombolysis. 2009 Nov;28(4):425-8. doi: 10.1007/s11239-008-0299-6. Epub 2008 Dec 6.
PubMed 19067121Sharrock NE, Go G, Sculco TP, Ranawat CS, Maynard MJ, Harpel PC. Changes in circulatory indices of thrombosis and fibrinolysis during total knee arthroplasty performed under tourniquet. J Arthroplasty. 1995 Aug;10(4):523-8. doi: 10.1016/s0883-5403(05)80155-x.
PubMed 8523013Estebe JP, Davies JM, Richebe P. The pneumatic tourniquet: mechanical, ischaemia-reperfusion and systemic effects. Eur J Anaesthesiol. 2011 Jun;28(6):404-11. doi: 10.1097/EJA.0b013e328346d5a9.
PubMed 21502865
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tourniquet Study: Is the High Thrombosis Risk After Knee Arthroscopy Caused by Limb-tourniquet Application? A Randomized Clinical Trial Into the Effect of Tourniquet Use on the Coagulation System
- ClinicalTrials.gov ID
- NCT02567903
- Acronym / sponsor ID
- NL49117.058.14
- Conditions
- Venous Thrombosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Groene Hart ZiekenhuisUniversity, hospital or other
- Collaborators
- Leiden University Medical Center
- Study start
- Sep 2015 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 5 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Knee arthroscopy is the most commonly performed orthopaedic procedure worldwide, with, according to the American Society for Sports Medicine, over 4 million procedures performed each year. The risk of venous thrombosis following this procedure is considerable with rates of symptomatic events varying between 0.9% and 4.6%. It is currently unknown how this high risk comes about considering its short duration and minimal tissue damage caused by the procedure. A factor that may play a role is the use of a tourniquet. A large majority of orthopaedic surgeons prefer to operate within a 'dry field', which is obtained by the use of a tourniquet. Tourniquet applied surgery is not without risks. Although its use during orthopedic surgery is widely accepted and a standard procedure, tourniquet use can lead to loss of muscle functional strength and contractile speed, vessel wall damage and nerve injury, next to the possibly increased risk of venous thrombosis. In the proposed study the investigators will investigate the effect of a tourniquet on local and systemic markers of hypoxia, inflammation, involvement of endothelium, and coagulation activation. A finding of more prominent activation of the coagulation system with tourniquet use than with non-use will create an important opportunity to prevent thromboembolic events in these patients, as it has been shown that knee arthroscopy can be performed adequately without the use of a tourniquet. Furthermore, it will increase the understanding of the pathophysiology of thrombosis.
Detailed description
Background
Knee arthroscopy is the most commonly performed orthopaedic procedure worldwide, with, according to the American Society for Sports Medicine, over 4 million procedures performed each year. The risk of venous thrombosis following this procedure is considerable with rates of symptomatic events varying between 0.9% and 4.6%.
It is currently unknown how this high risk comes about considering its short duration and minimal tissue damage caused by the procedure. A factor that may play a role is the use of a tourniquet. A large majority of orthopaedic surgeons prefer to operate within a 'dry field', which is obtained by the use of a tourniquet. In the proposed study the investigators will investigate the effect of a tourniquet on local and systemic markers of hypoxia, inflammation, involvement of endothelium, and coagulation activation.
Objective
To investigate the effect of tourniquet application on the coagulation system in patients undergoing a knee arthroscopy. A finding of more prominent activation of the coagulation system with tourniquet use than with non-use will create an important opportunity to prevent thromboembolic events in these patients, as it has been shown that knee arthroscopy can be performed adequately without the use of a tourniquet. Furthermore, it will increase the understanding of the pathophysiology of thrombosis.
Study Design
In a randomized, controlled clinical study the investigators will compare local and systemic coagulation and inflammation markers before and after knee arthroscopy between two groups: 25 patients will be randomized to arthroscopy with tourniquet (Group I) and 25 patients to arthroscopy without tourniquet (Group II).
Inclusion and exclusion criteria
The patients will be recruited from one hospital in Gouda over a 6 months inclusion period. All patients over 18 years, scheduled for a meniscectomy, diagnostic arthroscopy or removal of corpora libera will be eligible for inclusion. Patients will be excluded when they suffer from any kind of coagulation disorder, use of hormonal anticonception, in case of pregnancy or puerperium, when they have a history of venous thrombosis, had major surgery or cast-immobilisation of the lower extremity in the past two months, have a neoplasm or inflammatory disease, have a BMI>30, or when they use anticoagulant therapy. Patients will generally receive spinal anaesthesia. Patients who are nevertheless exposed to any other type of anaesthesia will be excluded as well, to keep the effect of anaesthesia equal for all participants.
Intervention
Patients will be randomized to knee arthroscopy without tourniquet use and to knee arthroscopy with tourniquet use. In patients randomized to arthroscopy with tourniquet use, exsanguination in the leg in which the knee arthroscopy will be performed will be accomplished by raising the leg vertically for one minute. The tourniquet will be inflated to 100-150 mmHg above systolic blood pressure.
Data on duration of surgery and duration of tourniquet use will be collected. Blood collected from the cubital vein and the great saphenous vein during arthroscopy of the knee will be analyzed on outcome parameters that reflect a hypoxic state, an inflammatory reaction, involvement of the endothelium, a procoagulant state and thrombin formation.
Main study endpoints (primary)
Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery will be analyzed.
Different patterns will be analyzed to explore the effect of tourniquet application on the coagulation system by possible biological mechanism. A change (increase or decrease) of markers within one pattern, compared to baseline measurements (before surgery), is considered as a relevant shift of that pattern, thereby suggesting the involvement of that specific pathway.
Outcome parameters that reflect a hypoxic state:
- pH
- pO2
- pCO2
- Lactate
Outcome parameters that reflect an inflammatory reaction:
- White Blood Cell Count (WBCC)
- E-selectin
- Neutrophil Extracellular traps (NETs)
Outcome parameters that reflect involvement of the endothelium:
- Von Willebrand Factor (vWF)
- Thrombomodulin
- E-selectin
Outcome parameters that reflect a procoagulant state and thrombin formation:
- Prothrombin fragments 1+2
- D-dimer
- Plasmin Activator Inhibitor 1 (PAI 1)
- Tissue plasminogen activator (tPA)
- Factor VIII
- Thrombin and Antithrombin complexes (TAT)
- Plasmin and antiplasmin complexes (PAP)
Secondary study paramaters
- Visibility during arthroscopy and technical difficulty score.
Time Schedule
Month 1-3: Completion of study protocol, procedure for approval by METC. Set up of database and randomisation procedure. Instruction of participating clinicians and surgery/anaesthesia staff.
Month 4-6: Inclusion of patients, data collection. Month 7-8: Laboratory tests. Month 9-12: Data analysis, writing and submission of manuscript.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Tourniquet | Active comparator | Procedure: Knee arthroscopyKnee arthroscopy without the use of a thigh tourniquet. |
| Tourniquet | Experimental | Device: Thigh Tourniquet, Procedure: Knee arthroscopyKnee arthroscopy with the use of a thigh tourniquet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Meniscectomy
- Diagnostic arthroscopy
- Removal of corpora libera
Key exclusion criteria (10 listed)
- Any kind of coagulation disorder
- pregnant or within 3 months of childbirth
- Use of hormonal anticonception
- A history of venous thrombosis
- Had major surgery in the past two months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thigh TourniquetKnee arthroscopy with the use of a thigh tourniquet that is inflated to 100-150 mmHg above systolic blood pressure. | Device | Tourniquet |
| Knee arthroscopyKnee arthroscopy | Procedure or surgery | No Tourniquet, Tourniquet |
Primary outcome
Change in parameters that reflect a hypoxic state assessed by pH
Time frame: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery.
Change in pH between timepoints
Change in parameters that reflect a hypoxic state assessed by pO2
Time frame: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery.
Change in pO2 between timepoints
Change in parameters that reflect a hypoxic state assessed by pCO2
Time frame: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery.
Change in pCO2 between timepoints
Change in parameters that reflect a hypoxic state assessed by Lactate
Time frame: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery.
Change in Lactate between timepoints
Change in parameters that reflect an inflammatory reaction assessed by WBCC
Time frame: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery.
Change in White Blood Cell Count (WBCC) between timepoints
Change in parameters that reflect an inflammatory reaction and/or endothelium involvement assessed by E-selectin
Time frame: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery.
Change in E-selectin between timepoints
Change in parameters that reflect an inflammatory reaction assessed by NETs
Time frame: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery.
Change in Neutrophil Extracellular traps (NETs) between timepoints
Outcome parameters that reflect involvement of the endothelium assessed by vWF
Time frame: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery.
Change in Von Willebrand Factor (vWF) between timepoints
Outcome parameters that reflect involvement of the endothelium assessed by thrombomodulin.
Time frame: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery.
Change in Thrombomodulin between timepoints
Outcome parameters that reflect involvement of the endothelium assessed by f 1+2
Time frame: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery.
Change in Prothrombin fragments 1+2 (f 1+2) between timepoints
Outcome parameters that reflect a procoagulant state and thrombin formation assessed by D-dimer
Time frame: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery.
Change in D-dimer between timepoints
Outcome parameters that reflect a procoagulant state and thrombin formation assessed by PAI 1
Time frame: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery.
Change in Plasmin Activator Inhibitor 1 (PAI 1) between timepoints
Outcome parameters that reflect a procoagulant state and thrombin formation assessed by tPA
Time frame: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery.
Change in Tissue plasminogen activator (tPA) between timepoints
Outcome parameters that reflect a procoagulant state and thrombin formation assessed by factor VIII
Time frame: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery.
Change in Factor VIII between timepoints
Outcome parameters that reflect a procoagulant state and thrombin formation assessed by TAT
Time frame: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery.
Change in Thrombin and Antithrombin complexes (TAT) between timepoints
Outcome parameters that reflect a procoagulant state and thrombin formation assessed by PAP
Time frame: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery.
Change in Plasmin and antiplasmin complexes (PAP) between timepoints
3 secondary outcomes
Duration of surgery
Time frame: intraoperative, duration in minutes between first incision until closure
Duration of tourniquet use
Time frame: intraoperative, duration in minutes between tourniquet inflation and deflation
Per-operative visibility
Time frame: Per-operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- BackgroundAmerican Academy of Orthopaedic Surgeons. Knee Arthroscopy. 2013. http://orthoinfo.aaos.org/topic.cfm?topic=a00299. Accessed April 15, 2014
- Background: PubMed 18574271Geerts WH, Bergqvist D, Pineo GF, Heit JA, Samama CM, Lassen MR, Colwell CW. Prevention of venous thromboembolism: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008 Jun;133(6 Suppl):381S-453S. doi: 10.1378/chest.08-0656.
- Background: PubMed 12871434Hoppener MR, Ettema HB, Kraaijenhagen RA, Verheyen CC, Henny PC. Day-care or short-stay surgery and venous thromboembolism. J Thromb Haemost. 2003 Apr;1(4):863-5. doi: 10.1046/j.1538-7836.2003.t01-9-00115.x. No abstract available.
- Background: PubMed 15634289Hoppener MR, Ettema HB, Henny CP, Verheyen CC, Buller HB. Symptomatic deep vein thrombosis and immobilization after day-care arthroscopy of the knee. J Thromb Haemost. 2005 Jan;3(1):185-7. doi: 10.1111/j.1538-7836.2004.01091.x. No abstract available.
- Background: PubMed 17068708Hoppener MR, Ettema HB, Henny CP, Verheyen CC, Buller HR. Low incidence of deep vein thrombosis after knee arthroscopy without thromboprophylaxis: a prospective cohort study of 335 patients. Acta Orthop. 2006 Oct;77(5):767-71. doi: 10.1080/17453670610012962.
- Background: PubMed 18626046Camporese G, Bernardi E, Prandoni P, Noventa F, Verlato F, Simioni P, Ntita K, Salmistraro G, Frangos C, Rossi F, Cordova R, Franz F, Zucchetta P, Kontothanassis D, Andreozzi GM; KANT (Knee Arthroscopy Nadroparin Thromboprophylaxis) Study Group. Low-molecular-weight heparin versus compression stockings for thromboprophylaxis after knee arthroscopy: a randomized trial. Ann Intern Med. 2008 Jul 15;149(2):73-82. doi: 10.7326/0003-4819-149-2-200807150-00003.
- Background: PubMed 15944631Ilahi OA, Reddy J, Ahmad I. Deep venous thrombosis after knee arthroscopy: a meta-analysis. Arthroscopy. 2005 Jun;21(6):727-30. doi: 10.1016/j.arthro.2005.03.007.
- Background: PubMed 18843687Ramos J, Perrotta C, Badariotti G, Berenstein G. Interventions for preventing venous thromboembolism in adults undergoing knee arthroscopy. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD005259. doi: 10.1002/14651858.CD005259.pub3.
- Background: PubMed 21034220Bovill EG, van der Vliet A. Venous valvular stasis-associated hypoxia and thrombosis: what is the link? Annu Rev Physiol. 2011;73:527-45. doi: 10.1146/annurev-physiol-012110-142305.
- Background: PubMed 10693564Aglietti P, Baldini A, Vena LM, Abbate R, Fedi S, Falciani M. Effect of tourniquet use on activation of coagulation in total knee replacement. Clin Orthop Relat Res. 2000 Feb;(371):169-77. doi: 10.1097/00003086-200002000-00021.
- Background: PubMed 15777299Katsumata S, Nagashima M, Kato K, Tachihara A, Wauke K, Saito S, Jin E, Kawanami O, Ogawa R, Yoshino S. Changes in coagulation-fibrinolysis marker and neutrophil elastase following the use of tourniquet during total knee arthroplasty and the influence of neutrophil elastase on thromboembolism. Acta Anaesthesiol Scand. 2005 Apr;49(4):510-6. doi: 10.1111/j.1399-6576.2005.00621.x.
- Background: PubMed 17408407Kageyama K, Nakajima Y, Shibasaki M, Hashimoto S, Mizobe T. Increased platelet, leukocyte, and endothelial cell activity are associated with increased coagulability in patients after total knee arthroplasty. J Thromb Haemost. 2007 Apr;5(4):738-45. doi: 10.1111/j.1538-7836.2007.02443.x.
Related trials for Venous Thrombosis
RecruitingPhase 2
SBRT With Immunotherapy and Atezo-Bev in HCC With Major Portal Vein Thrombosis
HCC
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzanne C Cannegieter, MD, PhD study chair
Leiden University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thigh Tourniquet and Knee arthroscopy in people with Venous Thrombosis, run by Groene Hart Ziekenhuis at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in parameters that reflect a hypoxic state assessed by pH (time frame: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery.). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02567903, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.