Arthritis KneeNCT05691751
Blood Loss Assessment in the Limited Application of Tourniquet During Primary Unilateral TKA
A study testing primary unilateral total knee arthroplasty with limited application of tourniquet and primary unilateral total knee arthroplasty with full application of tourniquet in people with Arthritis Knee and Blood Loss, run by Damascus University at 1 site in Syria.
Trial summary
Tourniquet application in total knee arthroplasty has many benefits and might have a role in the incidence of peri-operative complications the aim of this research: is to look into the effectiveness of the limited application of tourniquet during primary unilateral total knee arthroplasty and compare the perioperative… Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Arthritis Knee, Blood Loss, Arthroplasty Complications
- What is being tested?
- primary unilateral total knee arthroplasty with limited application of tourniquet and primary unilateral total knee arthroplasty with full application of tourniquet
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteSyria
- Study dates
- 1 Jan 2021to 23 Aug 2022
- 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 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients between 50 and 85 years of age with end-stage knee arthritis going primary unilateral TKA after the failure of conservative treatment.
Who cannot join
- o Patients younger than 50y and older than 85y.
- BMI less than 20 and more than 35.
- Patients having a vascular or hematologic disease.
- Patients who were taking anti-coagulant medicine and can't stop it.
- Patients having acute or chronic renal failure.
- Patients classified as the AAA as grade four or five.
Show all 9Show fewer
- Post-traumatic and secondary knee arthritis patients.
- Revisions and complex primary cases.
- Patients with an active infection or a history of lower limp infection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Blood Loss Assessment in the Limited Application of Tourniquet During Primary Unilateral TKA: a Randomized Controlled Study
Tourniquet application in total knee arthroplasty has many benefits and might have a role in the incidence of peri-operative complications the aim of this research: is to look into the effectiveness of the limited application of tourniquet during primary unilateral total knee arthroplasty and compare the perioperative complications with the standard full-time application.
Read the detailed description
Tourniquet application has been a routine choice for most joint surgeons around the world, reducing intra-operative blood loss and the better clearance of the surgical field and the better cementation technique with a blood-free cancellous bone are the main benefits, while the possible negatives are the pain of the thigh, skin burns, neurovascular complications and possibly increased risk of VTE, and the literature states a new orientation towards reducing the time of application of tourniquet or even eliminating it, favoring avoiding its risks rather than captivating its benefits so the investigator conducted a prospective randomized double-blinded controlled study, and enrolled 62 patients between the beginning of 2021 and august,2022.
after obtaining informed consent and approval by the institutional review board, the study was done in Damascus Syria, the investigator followed up every patient for six months, Participants were randomly assigned following simple randomization procedures (computerized random numbers) to 1 of 2 treatment groups, and the allocation was put into concealed envelopes independent of the surgeon and the author and the randomization was performed by a research fellow who was not involved in patient care, the tourniquet was applicated around the proximal thigh in all patients, the first group went unilateral primary TKA with inflating the tourniquet prior to incision and releasing it after closure and compression bandage application, while the second group went primary unilateral TKA with the tourniquet inflated only during cementation and final components application, the procedures were done under general, spinal or regional anesthesia based on the anesthetist consultant, a based-on-weight tranexamic acid dose was given intravenously before incision, all procedures was done by the same surgeon using the medial para-patellar approach , and the protheses used in all patients were cruciate scarifying cemented DePuy Synthes PFC Sigma without resurfacing of the patella, intramedullary guides were uses for the femoral and tibial cuts, the patients were blinded to the intervention during the whole period of the study, while the surgeon and the author were unblinded by opening the envelope by a research member just before initiating anesthesia
- Conditions
- Arthritis Knee, Blood Loss, Arthroplasty Complications
- Being tested
- primary unilateral total knee arthroplasty with limited application of tourniquet, primary unilateral total knee arthroplasty with full application of tourniquet
- Keywords
- total knee arthroplasty, blood loss, tourniquet, complications
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
primary unilateral total knee arthroplasty with limited application of tourniquetProcedure or surgery
the tourniquet will be applicated around the proximal thigh in all patients before the incision, all patients will undergo primary unilateral TKA by the same surgeon using the medial para-patellar approach, and the prostheses used in all patients will be cruciate scarifying cemented DePuy Synthes PFC Sigma without resurfacing of the patella, intramedullary guides will be used for the femoral and tibial cuts as seen appropriate by the surgeon, however, the application time of the tourniquet during surgery will be as the allocation of each patient imply.
primary unilateral total knee arthroplasty with full application of tourniquetProcedure or surgery
the tourniquet will be applicated around the proximal thigh in all patients before the incision, all patients will undergo primary unilateral TKA by the same surgeon using the medial para-patellar approach, and the prostheses used in all patients will be
| Study group | Role | What they receive |
|---|---|---|
| limited application | Experimental | Will go primary unilateral TKA with the tourniquet inflated only during cementation and final components of the prosthesis application Receives: Procedure: primary unilateral total knee arthroplasty with limited application of tourniquet |
| full-time application | Experimental | will go unilateral primary TKA with inflating the tourniquet prior to incision and releasing it after closure and compression bandage application Receives: Procedure: primary unilateral total knee arthroplasty with full application of tourniquet |
What is being measured
The primary outcome is the main question the study is designed to answer.
total estimated blood loss
the total amount of lost blood in the perioperative period and will be calculated using the Gross formula which is estimated by hitting the patients' blood volume by the difference between pre and post-operative hematocrit value divided by the initial hematocrit value
Measured: measured once 2 days after surgery
intra-operative blood loss
the amount of lost blood intraoperatively and will be measured by calculating the increased weight of the utilized wet mops and the volume of the suction bottle after erasing the amount of the used lavage
Measured: measured once by the time of closure of the incision
post-operative blood loss
the amount of lost blood postoperatively will be calculated as the output of the drain bottle
Measured: measured once 2 days after surgery
hidden blood loss
the amount of lost blood in the tissues that were not measured intraoperatively or postoperatively and will be calculated using the difference between total blood loss and intra and post-operative blood loss
Measured: measured once 2 days after surgery
Secondary outcomes (3)
duration of surgery
the time of duration of surgery from incision to bandage application measured by minutes
Measured: measured once at the time of bandage application after closure
surgical field clearance
surgical field clearance as evaluated by the surgeon
Measured: measured once by the time of closure of incision
perioperative complications
like the incidence of infection, VTE, etc
Measured: assessed within two weeks intervals until 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start1 Jan 2021
- Primary completion23 Aug 2022
- Study completion23 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Arthritis KneeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- jaber ibrahim, MD PHD, Study chair, Damascus university - faculty of medicine - department of surgeryhakam alasaad, MD, Study director, Damascus university - faculty of medicine - department of surgerydoried Diri, MD, Principal investigator, Damascus university - faculty of medicine - department of surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05691751
- Sponsor's protocol ID
- UDMS-Orthopedics-1-2023
- Status last verified
- Oct 2023
- First submitted
- 11 Jan 2023
- Last updated
- 24 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Adie S, Harris I, Chuan A, Lewis P, Naylor JM. Selecting and optimising patients for total knee arthroplasty. Med J Aust. 2019 Feb;210(3):135-141. doi: 10.5694/mja2.12109. Epub 2019 Jan 18.
PubMed 30656689Singh JA. Epidemiology of knee and hip arthroplasty: a systematic review. Open Orthop J. 2011 Mar 16;5:80-5. doi: 10.2174/1874325001105010080.
PubMed 21584277Whittaker JL, Truong LK, Dhiman K, Beck C. Osteoarthritis year in review 2020: rehabilitation and outcomes. Osteoarthritis Cartilage. 2021 Feb;29(2):190-207. doi: 10.1016/j.joca.2020.10.005. Epub 2020 Nov 24.
PubMed 33242604Xu H, Yang J, Xie J, Huang Z, Huang Q, Cao G, Pei F. Tourniquet use in routine primary total knee arthroplasty is associated with a higher transfusion rate and longer postoperative length of stay: a real-world study. BMC Musculoskelet Disord. 2020 Sep 18;21(1):620. doi: 10.1186/s12891-020-03623-5.
PubMed 32948173Horlocker TT, Hebl JR, Gali B, Jankowski CJ, Burkle CM, Berry DJ, Zepeda FA, Stevens SR, Schroeder DR. Anesthetic, patient, and surgical risk factors for neurologic complications after prolonged total tourniquet time during total knee arthroplasty. Anesth Analg. 2006 Mar;102(3):950-5. doi: 10.1213/01.ane.0000194875.05587.7e.
PubMed 16492857Dunn CJ, Goa KL. Tranexamic acid: a review of its use in surgery and other indications. Drugs. 1999 Jun;57(6):1005-32. doi: 10.2165/00003495-199957060-00017.
PubMed 10400410Gross JB. Estimating allowable blood loss: corrected for dilution. Anesthesiology. 1983 Mar;58(3):277-80. doi: 10.1097/00000542-198303000-00016. No abstract available.
PubMed 6829965Vaishya R, Chauhan M, Vaish A. Bone cement. J Clin Orthop Trauma. 2013 Dec;4(4):157-63. doi: 10.1016/j.jcot.2013.11.005. Epub 2013 Dec 15.
PubMed 26403875Schroer WC, Berend KR, Lombardi AV, Barnes CL, Bolognesi MP, Berend ME, Ritter MA, Nunley RM. Why are total knees failing today? Etiology of total knee revision in 2010 and 2011. J Arthroplasty. 2013 Sep;28(8 Suppl):116-9. doi: 10.1016/j.arth.2013.04.056. Epub 2013 Aug 15.
PubMed 23954423Park JH, Restrepo C, Norton R, Mandel S, Sharkey PF, Parvizi J. Common peroneal nerve palsy following total knee arthroplasty: prognostic factors and course of recovery. J Arthroplasty. 2013 Oct;28(9):1538-42. doi: 10.1016/j.arth.2013.02.025. Epub 2013 Apr 4.
PubMed 23562462Sundaram K, Udo-Inyang I, Mont MA, Molloy R, Higuera-Rueda C, Piuzzi NS. Vascular Injuries in Total Knee Arthroplasty: A Systematic Review and Meta-Analysis. JBJS Rev. 2020 Jan;8(1):e0051. doi: 10.2106/JBJS.RVW.19.00051.
PubMed 32105241Ejaz A, Laursen AC, Kappel A, Laursen MB, Jakobsen T, Rasmussen S, Nielsen PT. Faster recovery without the use of a tourniquet in total knee arthroplasty. Acta Orthop. 2014 Aug;85(4):422-6. doi: 10.3109/17453674.2014.931197. Epub 2014 Jun 23.
PubMed 24954487Tai TW, Lin CJ, Jou IM, Chang CW, Lai KA, Yang CY. Tourniquet use in total knee arthroplasty: a meta-analysis. Knee Surg Sports Traumatol Arthrosc. 2011 Jul;19(7):1121-30. doi: 10.1007/s00167-010-1342-7. Epub 2010 Dec 15.
PubMed 21161177Sehat KR, Evans RL, Newman JH. Hidden blood loss following hip and knee arthroplasty. Correct management of blood loss should take hidden loss into account. J Bone Joint Surg Br. 2004 May;86(4):561-5.
PubMed 15174554Gao FQ, Li ZJ, Zhang K, Sun W, Zhang H. Four Methods for Calculating Blood-loss after Total Knee Arthroplasty. Chin Med J (Engl). 2015 Nov 5;128(21):2856-60. doi: 10.4103/0366-6999.168041.
PubMed 26521781
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Loss Assessment in the Limited Application of Tourniquet During Primary Unilateral TKA: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05691751
- Acronym / sponsor ID
- UDMS-Orthopedics-1-2023
- Conditions
- Arthritis Knee, Blood Loss, Arthroplasty Complications
- Keywords
- total knee arthroplasty, blood loss, tourniquet, complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 23 Aug 2022 (actual)
- Study completion
- 23 Aug 2022 (actual)
- First posted
- 20 Jan 2023 (actual)
- 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.
Tourniquet application in total knee arthroplasty has many benefits and might have a role in the incidence of peri-operative complications the aim of this research: is to look into the effectiveness of the limited application of tourniquet during primary unilateral total knee arthroplasty and compare the perioperative complications with the standard full-time application.
Detailed description
Tourniquet application has been a routine choice for most joint surgeons around the world, reducing intra-operative blood loss and the better clearance of the surgical field and the better cementation technique with a blood-free cancellous bone are the main benefits, while the possible negatives are the pain of the thigh, skin burns, neurovascular complications and possibly increased risk of VTE, and the literature states a new orientation towards reducing the time of application of tourniquet or even eliminating it, favoring avoiding its risks rather than captivating its benefits so the investigator conducted a prospective randomized double-blinded controlled study, and enrolled 62 patients between the beginning of 2021 and august,2022.
after obtaining informed consent and approval by the institutional review board, the study was done in Damascus Syria, the investigator followed up every patient for six months, Participants were randomly assigned following simple randomization procedures (computerized random numbers) to 1 of 2 treatment groups, and the allocation was put into concealed envelopes independent of the surgeon and the author and the randomization was performed by a research fellow who was not involved in patient care, the tourniquet was applicated around the proximal thigh in all patients, the first group went unilateral primary TKA with inflating the tourniquet prior to incision and releasing it after closure and compression bandage application, while the second group went primary unilateral TKA with the tourniquet inflated only during cementation and final components application, the procedures were done under general, spinal or regional anesthesia based on the anesthetist consultant, a based-on-weight tranexamic acid dose was given intravenously before incision, all procedures was done by the same surgeon using the medial para-patellar approach , and the protheses used in all patients were cruciate scarifying cemented DePuy Synthes PFC Sigma without resurfacing of the patella, intramedullary guides were uses for the femoral and tibial cuts, the patients were blinded to the intervention during the whole period of the study, while the surgeon and the author were unblinded by opening the envelope by a research member just before initiating anesthesia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| limited application | Experimental | Procedure: primary unilateral total knee arthroplasty with limited application of tourniquetWill go primary unilateral TKA with the tourniquet inflated only during cementation and final components of the prosthesis application |
| full-time application | Experimental | Procedure: primary unilateral total knee arthroplasty with full application of tourniquetwill go unilateral primary TKA with inflating the tourniquet prior to incision and releasing it after closure and compression bandage application |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients between 50 and 85 years of age with end-stage knee arthritis going primary unilateral TKA after the failure of conservative treatment.
Key exclusion criteria (9 listed)
- o Patients younger than 50y and older than 85y.
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 |
|---|---|---|
| primary unilateral total knee arthroplasty with limited application of tourniquetthe tourniquet will be applicated around the proximal thigh in all patients before the incision, all patients will undergo primary unilateral TKA by the same surgeon using the medial para-patellar approach, and the prostheses used in all patients will be cruciate scarifying cemented DePuy Synthes PFC Sigma without resurfacing of the patella, intramedullary guides will be used for the femoral and tibial cuts as seen appropriate by the surgeon, however, the application time of the tourniquet during surgery will be as the allocation of each patient imply. | Procedure or surgery | limited application |
| primary unilateral total knee arthroplasty with full application of tourniquetthe tourniquet will be applicated around the proximal thigh in all patients before the incision, all patients will undergo primary unilateral TKA by the same surgeon using the medial para-patellar approach, and the prostheses used in all patients will be | Procedure or surgery | full-time application |
Primary outcome
total estimated blood loss
Time frame: measured once 2 days after surgery
the total amount of lost blood in the perioperative period and will be calculated using the Gross formula which is estimated by hitting the patients' blood volume by the difference between pre and post-operative hematocrit value divided by the initial hematocrit value
intra-operative blood loss
Time frame: measured once by the time of closure of the incision
the amount of lost blood intraoperatively and will be measured by calculating the increased weight of the utilized wet mops and the volume of the suction bottle after erasing the amount of the used lavage
post-operative blood loss
Time frame: measured once 2 days after surgery
the amount of lost blood postoperatively will be calculated as the output of the drain bottle
hidden blood loss
Time frame: measured once 2 days after surgery
the amount of lost blood in the tissues that were not measured intraoperatively or postoperatively and will be calculated using the difference between total blood loss and intra and post-operative blood loss
3 secondary outcomes
duration of surgery
Time frame: measured once at the time of bandage application after closure
surgical field clearance
Time frame: measured once by the time of closure of incision
perioperative complications
Time frame: assessed within two weeks intervals until 6 months after surgery
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 24 Oct 2023.
- Background: PubMed 30656689Adie S, Harris I, Chuan A, Lewis P, Naylor JM. Selecting and optimising patients for total knee arthroplasty. Med J Aust. 2019 Feb;210(3):135-141. doi: 10.5694/mja2.12109. Epub 2019 Jan 18.
- Background: PubMed 21584277Singh JA. Epidemiology of knee and hip arthroplasty: a systematic review. Open Orthop J. 2011 Mar 16;5:80-5. doi: 10.2174/1874325001105010080.
- Background: PubMed 33242604Whittaker JL, Truong LK, Dhiman K, Beck C. Osteoarthritis year in review 2020: rehabilitation and outcomes. Osteoarthritis Cartilage. 2021 Feb;29(2):190-207. doi: 10.1016/j.joca.2020.10.005. Epub 2020 Nov 24.
- Background: PubMed 32948173Xu H, Yang J, Xie J, Huang Z, Huang Q, Cao G, Pei F. Tourniquet use in routine primary total knee arthroplasty is associated with a higher transfusion rate and longer postoperative length of stay: a real-world study. BMC Musculoskelet Disord. 2020 Sep 18;21(1):620. doi: 10.1186/s12891-020-03623-5.
- Background: PubMed 16492857Horlocker TT, Hebl JR, Gali B, Jankowski CJ, Burkle CM, Berry DJ, Zepeda FA, Stevens SR, Schroeder DR. Anesthetic, patient, and surgical risk factors for neurologic complications after prolonged total tourniquet time during total knee arthroplasty. Anesth Analg. 2006 Mar;102(3):950-5. doi: 10.1213/01.ane.0000194875.05587.7e.
- Background: PubMed 10400410Dunn CJ, Goa KL. Tranexamic acid: a review of its use in surgery and other indications. Drugs. 1999 Jun;57(6):1005-32. doi: 10.2165/00003495-199957060-00017.
- Background: PubMed 6829965Gross JB. Estimating allowable blood loss: corrected for dilution. Anesthesiology. 1983 Mar;58(3):277-80. doi: 10.1097/00000542-198303000-00016. No abstract available.
- Background: PubMed 26403875Vaishya R, Chauhan M, Vaish A. Bone cement. J Clin Orthop Trauma. 2013 Dec;4(4):157-63. doi: 10.1016/j.jcot.2013.11.005. Epub 2013 Dec 15.
- Background: PubMed 23954423Schroer WC, Berend KR, Lombardi AV, Barnes CL, Bolognesi MP, Berend ME, Ritter MA, Nunley RM. Why are total knees failing today? Etiology of total knee revision in 2010 and 2011. J Arthroplasty. 2013 Sep;28(8 Suppl):116-9. doi: 10.1016/j.arth.2013.04.056. Epub 2013 Aug 15.
- Background: PubMed 23562462Park JH, Restrepo C, Norton R, Mandel S, Sharkey PF, Parvizi J. Common peroneal nerve palsy following total knee arthroplasty: prognostic factors and course of recovery. J Arthroplasty. 2013 Oct;28(9):1538-42. doi: 10.1016/j.arth.2013.02.025. Epub 2013 Apr 4.
- Background: PubMed 32105241Sundaram K, Udo-Inyang I, Mont MA, Molloy R, Higuera-Rueda C, Piuzzi NS. Vascular Injuries in Total Knee Arthroplasty: A Systematic Review and Meta-Analysis. JBJS Rev. 2020 Jan;8(1):e0051. doi: 10.2106/JBJS.RVW.19.00051.
- Background: PubMed 24954487Ejaz A, Laursen AC, Kappel A, Laursen MB, Jakobsen T, Rasmussen S, Nielsen PT. Faster recovery without the use of a tourniquet in total knee arthroplasty. Acta Orthop. 2014 Aug;85(4):422-6. doi: 10.3109/17453674.2014.931197. Epub 2014 Jun 23.
- Individual participant dataSharing planned: No
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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.
jaber ibrahim, MD PHD study chair
Damascus university - faculty of medicine - department of surgery
hakam alasaad, MD study director
Damascus university - faculty of medicine - department of surgery
doried Diri, MD principal investigator
Damascus university - faculty of medicine - department of surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing primary unilateral total knee arthroplasty with limited application of tourniquet and primary unilateral total knee arthroplasty with full application of tourniquet in people with Arthritis Knee and Blood Loss, run by Damascus University at 1 site in Syria.
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 1 inclusion and 9 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 24 Oct 2023. 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 Syria. 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?
total estimated blood loss (time frame: measured once 2 days after surgery). The study lists 4 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 NCT05691751, which also lists 23 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 24 Oct 2023.