Coagulation, BloodTEGLegNCT00726570
Alterations of Blood Clotting With the Use of Sequential Compression Devices on the Lower Limbs
A study testing Sequential compression device therapy, Dalteparin and TEG in people with Coagulation, Blood and Compression Devices, Intermittent Pneumatic, run by University of Parma at 1 site in Italy.
Trial summary
This study aims to assess possible alteration in coagulation (blood clotting) following treatment with sequential compression devices (SCD) plus low-molecular weight heparin (LMWH) as opposed to LMWH alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coagulation, Blood, Compression Devices, Intermittent Pneumatic, Postoperative Complications
- What is being tested?
- Sequential compression device therapy, Dalteparin and TEG
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Aug 2008to Nov 2010
- 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
- Elective major abdominal surgery for neoplasm
- Planned admission to postsurgical ICU due to the patient's meeting one or more of the following:
- ASA Physical Status Class 4
- Surgery of modified Johns-Hopkins class ≥IV
- ASA 3 with modified Johns-Hopkins class 3 surgery
- Expected duration of surgery ≥8 h
Who cannot join
- History of coagulation abnormalities, either congenital or acquired
- Ongoing treatment with anticoagulants/antiplatelet agents other than LMWH or hormones
- Massive edema of the legs
- Severe peripheral arteriopathy or neuropathy
- Malformations or recent surgery/trauma to the lower extremities
Trial locations and contacts
1 site in 1 country.
Italy1 site
University Hospital / Azienda Ospedaliero-Universitaria
Parma, PR, 43100
About this study
Official title: Effects of Sequential Compression Devices on Coagulation Parameters Assessed by TEG® in Patients Undergoing Major Abdominal Surgery
This study aims to assess possible alteration in coagulation (blood clotting) following treatment with sequential compression devices (SCD) plus low-molecular weight heparin (LMWH) as opposed to LMWH alone.
The investigators will examine coagulation in the early postoperative period of patients undergoing major abdominal surgery during their stay in our Intensive Care Unit.
In addition to common laboratory tests, the investigators will examine coagulation using TEG®, a device which allows a semi-quantitative examination of all phases of coagulation.
Read the detailed description
Low molecular weight heparins (LMWH) are routinely used in perioperative prophylaxis of thromboembolic complications [(chiefly deep vein thrombosis (DVT)]. LMWHs have been proved to be safe and equipotent or superior when compared with unfractionated heparin.
Sequential compressing devices (SCD) are relatively novel pneumatic stockings with several air chambers. A computerized pump applies a gradient of pressure which decreases from the foot cranially. Pressure is also applied intermittently according to predetermined schedules. This devices are being employed for DVT prophylaxis in patients for whom anticoagulation therapy is contraindicated, or in those who have a low risk of DVT. They have also been employed to complement anticoagulant therapy in patients at high risk of DVT, such as those undergoing orthopedic surgery (Fordyce, 1992; Handoll, 2002; Warwick, 2002; Pitto, 2004).
The mechanism of action of SCD seems to be primarily mechanical, through a displacement of a column of blood through the venous system and towards the heart; they act as a surrogate of the muscular pump in immobilized patients (Killewich, 1995).
There is also some evidence that SCD activity may influence the coagulation/fibrinolysis system towards hypocoagulability (Dai, 2000; Kohro, 2003); Kohro and colleagues have also hypothesized that the shear forces generated by SCD may alter platelet adhesion by a direct effect on platelets and/or by increasing the release of factors from the venous endothelium (Kohro, 2005).
The investigators aim to assess the effects on coagulation when SCD are applied to patients at high risk of DVT in addition to standard LMWH therapy.The investigators chose to study a population in whom SCD may be useful in reducing the incidence of DVT, such as patients undergoing postoperative monitoring in the intensive care unit (ICU) after major abdominal surgery for cancer.
In addition to standard laboratory tests, the investigators will use thrombelastography (TEG®) to assess all phases of coagulation. A TEG parameter, maximum amplitude (MA), has been linked to an increase of thrombotic complications in a postoperative population (McCrath, 2005).
- Conditions
- Coagulation, Blood, Compression Devices, Intermittent Pneumatic, Postoperative Complications, Thrombelastography
- Being tested
- Sequential compression device therapy, Dalteparin, TEG
- Keywords
- Disorders, Blood coagulation, Deep Vein Thrombosis, Perioperative Care, Digestive System Surgical Procedures
- Medical subject headings
- Thrombosis, Postoperative Complications, Blood Coagulation Disorders, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sequential compression device therapyDevice
Also called SCD EXPRESS, Foot pump
Pneumatic stockings will be applied to patients.
Pressures ranging from 12 to 40 mmHg will be applied at different levels of the lower limb for 40-second cycles at 2-minute intervals. Therapy will continue until the morning after surgery.
DalteparinDrug
Also called low molecular weight heparin, Fragmin, heparin, thromboprophylaxis
- 2500 UI qd if ≤ 50 kg body weight
- 5000 UI qd if > 50 kg
TEGProcedure or surgery
Also called thrombelastography, TEG®, thrombelastogram
A 2-ml blood sample will be used for each exam. A full analysis will be run both with and without heparinase at each time point.
TEG analyses will be run at:
- Patient admission (before SCD start)
- 40-60 min after admission
- Morning after surgery
| Study group | Role | What they receive |
|---|---|---|
| SCD + LMWH | Experimental | This group will receive sequential compression device therapy to the lower limbs from their ICU admission until the morning after surgery. Receives: Device: Sequential compression device therapy; Drug: Dalteparin; Procedure: TEG |
| LMWH only | Active comparator | Patients in this group will receive only standard LMWH therapy during their ICU stay. Receives: Drug: Dalteparin; Procedure: TEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in the area under the curve of maximum amplitude (MA) TEG value over time
Measured: 24 hours from application of SCD
Secondary outcomes (3)
Reduction in the area under the curve of the r time TEG value over time
Measured: 24 h after application of SCD
Reduction in the area under the curve of the alpha angle TEG value over time
Measured: 24 h after application of SCD
Incidence of hypotension (mean arterial pressure ≤60 mmHg)
Measured: ≤24 h after application of SCD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionNov 2010
- Study completionNov 2010
Why it stopped: Failed to reach the expected enrollment rates by the end of 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Coagulation, BloodStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Parma
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guido Fanelli, University of Parma
- Investigators
- Guido Fanelli, MD, Study chair, University of ParmaMaria Barbagallo, MD, Principal investigator, UO II Anestesia e Rianimazione, Azienda Ospedaliero-Universitaria di Parma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00726570
- Sponsor's protocol ID
- ICU-ICU-01
- Acronym
- TEGLeg
- Status last verified
- Nov 2013
- First submitted
- 29 Jul 2008
- Last updated
- 5 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Fordyce MJ, Ling RS. A venous foot pump reduces thrombosis after total hip replacement. J Bone Joint Surg Br. 1992 Jan;74(1):45-9. doi: 10.1302/0301-620X.74B1.1732264.
PubMed 1732264Handoll HH, Farrar MJ, McBirnie J, Tytherleigh-Strong G, Milne AA, Gillespie WJ. Heparin, low molecular weight heparin and physical methods for preventing deep vein thrombosis and pulmonary embolism following surgery for hip fractures. Cochrane Database Syst Rev. 2002;(4):CD000305. doi: 10.1002/14651858.CD000305.
PubMed 12519540Warwick D, Harrison J, Whitehouse S, Mitchelmore A, Thornton M. A randomised comparison of a foot pump and low-molecular-weight heparin in the prevention of deep-vein thrombosis after total knee replacement. J Bone Joint Surg Br. 2002 Apr;84(3):344-50. doi: 10.1302/0301-620x.84b3.12372.
PubMed 12002490Pitto RP, Hamer H, Heiss-Dunlop W, Kuehle J. Mechanical prophylaxis of deep-vein thrombosis after total hip replacement a randomised clinical trial. J Bone Joint Surg Br. 2004 Jul;86(5):639-42. doi: 10.1302/0301-620x.86b5.14763.
PubMed 15274256Killewich LA, Sandager GP, Nguyen AH, Lilly MP, Flinn WR. Venous hemodynamics during impulse foot pumping. J Vasc Surg. 1995 Nov;22(5):598-605. doi: 10.1016/s0741-5214(95)70046-3.
PubMed 7494362Dai G, Tsukurov O, Orkin RW, Abbott WM, Kamm RD, Gertler JP. An in vitro cell culture system to study the influence of external pneumatic compression on endothelial function. J Vasc Surg. 2000 Nov;32(5):977-87. doi: 10.1067/mva.2000.110357.
PubMed 11054230Kohro S, Yamakage M, Takahashi T, Ota K, Kondo M, Namiki A. Effects of intermittent pneumatic foot compression on blood coagulability and fibrinolysis assessed by a whole blood viscometer Sonoclot. J Anesth. 2003;17(3):208-10. doi: 10.1007/s00540-003-0180-x. No abstract available.
PubMed 12911214Kohro S, Yamakage M, Sato K, Sato JI, Namiki A. Intermittent pneumatic foot compression can activate blood fibrinolysis without changes in blood coagulability and platelet activation. Acta Anaesthesiol Scand. 2005 May;49(5):660-4. doi: 10.1111/j.1399-6576.2005.00661.x.
PubMed 15836680McCrath DJ, Cerboni E, Frumento RJ, Hirsh AL, Bennett-Guerrero E. Thromboelastography maximum amplitude predicts postoperative thrombotic complications including myocardial infarction. Anesth Analg. 2005 Jun;100(6):1576-1583. doi: 10.1213/01.ANE.0000155290.86795.12.
PubMed 15920177
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sequential Compression Devices on Coagulation Parameters Assessed by TEG® in Patients Undergoing Major Abdominal Surgery
- ClinicalTrials.gov ID
- NCT00726570
- Acronym / sponsor ID
- TEGLeg / ICU-ICU-01
- Conditions
- Coagulation, Blood, Compression Devices, Intermittent Pneumatic, Postoperative Complications, Thrombelastography
- Keywords
- Disorders, Blood coagulation, Deep Vein Thrombosis, Perioperative Care, Digestive System Surgical Procedures
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Failed to reach the expected enrollment rates by the end of 2010
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of ParmaUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 1 Aug 2008 (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.
This study aims to assess possible alteration in coagulation (blood clotting) following treatment with sequential compression devices (SCD) plus low-molecular weight heparin (LMWH) as opposed to LMWH alone.
The investigators will examine coagulation in the early postoperative period of patients undergoing major abdominal surgery during their stay in our Intensive Care Unit.
In addition to common laboratory tests, the investigators will examine coagulation using TEG®, a device which allows a semi-quantitative examination of all phases of coagulation.
Detailed description
Low molecular weight heparins (LMWH) are routinely used in perioperative prophylaxis of thromboembolic complications [(chiefly deep vein thrombosis (DVT)]. LMWHs have been proved to be safe and equipotent or superior when compared with unfractionated heparin.
Sequential compressing devices (SCD) are relatively novel pneumatic stockings with several air chambers. A computerized pump applies a gradient of pressure which decreases from the foot cranially. Pressure is also applied intermittently according to predetermined schedules. This devices are being employed for DVT prophylaxis in patients for whom anticoagulation therapy is contraindicated, or in those who have a low risk of DVT. They have also been employed to complement anticoagulant therapy in patients at high risk of DVT, such as those undergoing orthopedic surgery (Fordyce, 1992; Handoll, 2002; Warwick, 2002; Pitto, 2004).
The mechanism of action of SCD seems to be primarily mechanical, through a displacement of a column of blood through the venous system and towards the heart; they act as a surrogate of the muscular pump in immobilized patients (Killewich, 1995).
There is also some evidence that SCD activity may influence the coagulation/fibrinolysis system towards hypocoagulability (Dai, 2000; Kohro, 2003); Kohro and colleagues have also hypothesized that the shear forces generated by SCD may alter platelet adhesion by a direct effect on platelets and/or by increasing the release of factors from the venous endothelium (Kohro, 2005).
The investigators aim to assess the effects on coagulation when SCD are applied to patients at high risk of DVT in addition to standard LMWH therapy.The investigators chose to study a population in whom SCD may be useful in reducing the incidence of DVT, such as patients undergoing postoperative monitoring in the intensive care unit (ICU) after major abdominal surgery for cancer.
In addition to standard laboratory tests, the investigators will use thrombelastography (TEG®) to assess all phases of coagulation. A TEG parameter, maximum amplitude (MA), has been linked to an increase of thrombotic complications in a postoperative population (McCrath, 2005).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCD + LMWH | Experimental | Device: Sequential compression device therapy, Drug: Dalteparin, Procedure: TEGThis group will receive sequential compression device therapy to the lower limbs from their ICU admission until the morning after surgery. |
| LMWH only | Active comparator | Drug: Dalteparin, Procedure: TEGPatients in this group will receive only standard LMWH therapy during their ICU stay. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Elective major abdominal surgery for neoplasm
- Planned admission to postsurgical ICU due to the patient's meeting one or more of the following:
Key exclusion criteria (5 listed)
- History of coagulation abnormalities, either congenital or acquired
- Ongoing treatment with anticoagulants/antiplatelet agents other than LMWH or hormones
- Massive edema of the legs
- Severe peripheral arteriopathy or neuropathy
- Malformations or recent surgery/trauma to the lower extremities
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 |
|---|---|---|
| Sequential compression device therapyAlso: SCD EXPRESS, Foot pumpPneumatic stockings will be applied to patients. Pressures ranging from 12 to 40 mmHg will be applied at different levels of the lower limb for 40-second cycles at 2-minute intervals. Therapy will continue until the morning after surgery. | Device | SCD + LMWH |
| DalteparinAlso: low molecular weight heparin, Fragmin, heparin, thromboprophylaxis* 2500 UI qd if ≤ 50 kg body weight * 5000 UI qd if > 50 kg | Drug | LMWH only, SCD + LMWH |
| TEGAlso: thrombelastography, TEG®, thrombelastogramA 2-ml blood sample will be used for each exam. A full analysis will be run both with and without heparinase at each time point. TEG analyses will be run at: * Patient admission (before SCD start) * 40-60 min after admission * Morning after surgery | Procedure or surgery | LMWH only, SCD + LMWH |
Primary outcome
Reduction in the area under the curve of maximum amplitude (MA) TEG value over time
Time frame: 24 hours from application of SCD
3 secondary outcomes
Reduction in the area under the curve of the r time TEG value over time
Time frame: 24 h after application of SCD
Reduction in the area under the curve of the alpha angle TEG value over time
Time frame: 24 h after application of SCD
Incidence of hypotension (mean arterial pressure ≤60 mmHg)
Time frame: ≤24 h after application of SCD
Results and safety
The study was stopped early (reason given: Failed to reach the expected enrollment rates by the end of 2010). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2013.
- Background: PubMed 1732264Fordyce MJ, Ling RS. A venous foot pump reduces thrombosis after total hip replacement. J Bone Joint Surg Br. 1992 Jan;74(1):45-9. doi: 10.1302/0301-620X.74B1.1732264.
- Background: PubMed 12519540Handoll HH, Farrar MJ, McBirnie J, Tytherleigh-Strong G, Milne AA, Gillespie WJ. Heparin, low molecular weight heparin and physical methods for preventing deep vein thrombosis and pulmonary embolism following surgery for hip fractures. Cochrane Database Syst Rev. 2002;(4):CD000305. doi: 10.1002/14651858.CD000305.
- Background: PubMed 12002490Warwick D, Harrison J, Whitehouse S, Mitchelmore A, Thornton M. A randomised comparison of a foot pump and low-molecular-weight heparin in the prevention of deep-vein thrombosis after total knee replacement. J Bone Joint Surg Br. 2002 Apr;84(3):344-50. doi: 10.1302/0301-620x.84b3.12372.
- Background: PubMed 15274256Pitto RP, Hamer H, Heiss-Dunlop W, Kuehle J. Mechanical prophylaxis of deep-vein thrombosis after total hip replacement a randomised clinical trial. J Bone Joint Surg Br. 2004 Jul;86(5):639-42. doi: 10.1302/0301-620x.86b5.14763.
- Background: PubMed 7494362Killewich LA, Sandager GP, Nguyen AH, Lilly MP, Flinn WR. Venous hemodynamics during impulse foot pumping. J Vasc Surg. 1995 Nov;22(5):598-605. doi: 10.1016/s0741-5214(95)70046-3.
- Background: PubMed 11054230Dai G, Tsukurov O, Orkin RW, Abbott WM, Kamm RD, Gertler JP. An in vitro cell culture system to study the influence of external pneumatic compression on endothelial function. J Vasc Surg. 2000 Nov;32(5):977-87. doi: 10.1067/mva.2000.110357.
- Background: PubMed 12911214Kohro S, Yamakage M, Takahashi T, Ota K, Kondo M, Namiki A. Effects of intermittent pneumatic foot compression on blood coagulability and fibrinolysis assessed by a whole blood viscometer Sonoclot. J Anesth. 2003;17(3):208-10. doi: 10.1007/s00540-003-0180-x. No abstract available.
- Background: PubMed 15836680Kohro S, Yamakage M, Sato K, Sato JI, Namiki A. Intermittent pneumatic foot compression can activate blood fibrinolysis without changes in blood coagulability and platelet activation. Acta Anaesthesiol Scand. 2005 May;49(5):660-4. doi: 10.1111/j.1399-6576.2005.00661.x.
- Background: PubMed 15920177McCrath DJ, Cerboni E, Frumento RJ, Hirsh AL, Bennett-Guerrero E. Thromboelastography maximum amplitude predicts postoperative thrombotic complications including myocardial infarction. Anesth Analg. 2005 Jun;100(6):1576-1583. doi: 10.1213/01.ANE.0000155290.86795.12.
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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.
Guido Fanelli, MD study chair
University of Parma
Maria Barbagallo, MD principal investigator
UO II Anestesia e Rianimazione, Azienda Ospedaliero-Universitaria di Parma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sequential compression device therapy, Dalteparin and TEG in people with Coagulation, Blood and Compression Devices, Intermittent Pneumatic, run by University of Parma at 1 site in Italy.
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 6 inclusion and 5 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: stopped early, as of the sponsor's last update on 5 Nov 2013. 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 Italy. 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 was stopped early (reason given: Failed to reach the expected enrollment rates by the end of 2010). Results are not available in the source record.
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?
Reduction in the area under the curve of maximum amplitude (MA) TEG value over time (time frame: 24 hours from application of SCD). 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 NCT00726570, which also lists 9 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 Nov 2013.