Postpartum PeriodNCT07820670
Rivaroxaban vs Enoxaparin After Cesarean Section: Laboratory Thromboprophylaxis Outcomes
A study testing Rivaroxaban and Enoxaparin 40 mg in people with Postpartum Period and Cesarean Section Surgery, run by Wolfson Medical Center at 1 site in Israel.
Trial summary
Pregnancy and the postpartum period increase venous thromboembolism (VTE) risk. After cesarean section, low-molecular-weight heparin (LMWH; enoxaparin) is commonly used for short-term thromboprophylaxis, but it requires daily subcutaneous injections and can cause adverse effects. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Postpartum Period, Cesarean Section Surgery, VTE (Venous Thromboembolism)
- What is being tested?
- Rivaroxaban and Enoxaparin 40 mg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Dec 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Hebrew-speaking women
- age 18-50
- Elective cesarean at Wolfson
- Indicated for in-hospital thromboprophylaxis per local protocol (need ≥2 risk factors among: cesarean delivery; age >35; BMI >30; parity ≥3; labor duration ≥12 h; postpartum hemorrhage or blood transfusion; reduced mobility)
Who cannot join
- Known thrombophilia
- Prior arterial/venous thrombosis
- Creatinine clearance <29 mL/min
- Abnormal liver enzymes/bilirubin or liver disease
- Coagulation disorders
- Platelets <75,000/mm³
Show all 15Show fewer
- Interacting drugs affecting DOAC metabolism (e.g., strong CYP3A4/P-gp modulators; azoles; protease inhibitors; rifampicin; phenytoin; carbamazepine; phenobarbital; St. John's wort; dronedarone)
- Active bleeding or contraindication to anticoagulation
- Peptic disease/GI bleeding history
- Hemoptysis risk/history
- Preeclampsia
- Active infection
- Significant lower-limb varicosities
- Need for prophylaxis beyond discharge (≥3 risk factors)
- Maternal weight <50 kg or >100 kg
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Edith Wolfson Medical Center
Holon, 6997107
Hagit Eisenberg, MD, +972523397843, hagiteisen@yahoo.com
About this study
Official title: The Laboratory Effect of Rivaroxaban Compared to Enoxaparin as Prophylactic Anticoagulant Therapy After Cesarean Section: A Randomized Open-Label Trial
Pregnancy and the postpartum period increase venous thromboembolism (VTE) risk. After cesarean section, low-molecular-weight heparin (LMWH; enoxaparin) is commonly used for short-term thromboprophylaxis, but it requires daily subcutaneous injections and can cause adverse effects. Direct oral anticoagulants (DOACs) such as rivaroxaban offer convenient once-daily oral dosing. In women who meet institutional criteria for short-term postpartum thromboprophylaxis until hospital discharge, we will compare the laboratory anticoagulant effect of rivaroxaban versus enoxaparin using thrombin generation parameters.
This randomized, open-label trial will enroll women undergoing elective cesarean section who are indicated for in-hospital prophylaxis. Blood will be drawn on postoperative day 2 at trough (pre-dose) and peak (~3 hours post-dose) to measure thrombin generation, anti-Xa activity and drug levels, and participants will complete the Anti-Clot Treatment Scale (ACTS) satisfaction questionnaire. Safety follow-up will occur by telephone at 2 days post-discharge and at 6 weeks postpartum.
Read the detailed description
Randomized (1:1), open-label, parallel-group, single-center study at Wolfson Medical Center. Eligible participants (Hebrew-speaking, age 18-50, elective cesarean, and meeting local VTE prophylaxis criteria) are randomized to rivaroxaban 10 mg PO once daily or enoxaparin 40 mg SC once daily from the day of surgery until discharge (first dose ≥12 h after cesarean and ≥6 h after spinal anesthesia). On POD2 two blood draws are performed: trough pre-dose and peak ~3 h after dosing. Tests: PT, aPTT, anti-Xa with appropriate calibrators, thrombin generation (endogenous thrombin potential [ETP], lag time, peak thrombin). ACTS (Anti-Clot Treatment Scale (ACTS) satisfaction questionnaire) is administered before discharge. Safety follow-up calls 2 days after discharge and 6 weeks postpartum for bleeding, VTE, allergic reactions or other AEs.
- Being tested
- Rivaroxaban, Enoxaparin 40 mg
- Keywords
- Rivaroxaban, Enoxaparin, LMWH, DOAC, Thromboprophylaxis, Thrombin Generation, Endogenous Thrombin Potential, Post-cesarean
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RivaroxabanDrug
Also called Xarelto
10 mg PO once daily from ≥12 h post-C-section until discharge
Enoxaparin 40 mgDrug
Also called Clexane
40 mg SC once daily from ≥12 h post-C-section until discharge
| Study group | Role | What they receive |
|---|---|---|
| Rivaroxaban | Experimental | Participants receive rivaroxaban 10 mg orally (PO) once daily, starting ≥12 hours after cesarean delivery and ≥6 hours after spinal anesthesia, and continuing once daily during the index hospitalization until discharge. Standard postpartum care is provided to all participants. Receives: Drug: Rivaroxaban |
| Enoxaparin | Active comparator | Participants receive enoxaparin 40 mg subcutaneously (SC) once daily, starting ≥12 hours after cesarean delivery and ≥6 hours after spinal anesthesia, and continuing once daily during the index hospitalization until discharge. Standard postpartum care is provided to all participants Receives: Drug: Enoxaparin 40 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endogenous Thrombin Potential (ETP)
Between-group comparison of ETP to assess similarity of anticoagulant effect; lower ETP indicates greater anticoagulation.
Measured: Postoperative day 2: immediately before the study drug dose (trough) and approximately 3 hours after the study drug dose (peak), during the index hospitalization
Secondary outcomes (6)
Thrombin Generation - Lag Time (minutes)
Thrombin Generation - Lag Time (minutes)
Measured: Postoperative day 2: immediately before the study drug dose (trough) and approximately 3 hours after the study drug dose (peak), during the index hospitalization
Thrombin Generation - Peak Thrombin (nM)
Thrombin Generation - Peak Thrombin (nM)
Measured: Postoperative day 2: immediately before the study drug dose (trough) and approximately 3 hours after the study drug dose (peak), during the index hospitalization
Anti-Xa activity (IU/mL) - Enoxaparin arm
Anti-Xa activity (IU/mL) - Enoxaparin arm
Measured: Postoperative day 2: immediately before the enoxaparin dose (trough) and approximately 3 hours after the enoxaparin dose (peak), during the index hospitalization
Plasma Rivaroxaban Concentration (ng/mL) - Rivaroxaban arm
Plasma Rivaroxaban Concentration (ng/mL) - Rivaroxaban arm
Measured: Postoperative day 2: immediately before the rivaroxaban dose (trough) and approximately 3 hours after the rivaroxaban dose (peak), during the index hospitalization
Treatment Satisfaction (ACTS Questionnaire total and subscales)
The Anti-Clot Treatment Scale (validated patient-reported measure; higher scores reflect greater satisfaction)
Measured: Postoperative day 2, prior to hospital discharge
Adverse Events (bleeding and VTE)
Clinically evident bleeding, confirmed VTE events, allergic reactions, or other AEs possibly related to study drugs, collected during hospitalization and via phone at ~2 days post-discharge and 6 weeks.
Measured: From randomization through 6 weeks postpartum, including assessment during the index hospitalization, approximately 2 days after discharge, and at 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start1 Dec 2025
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Postpartum PeriodStudies 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
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hagit Eisenberg, Wolfson Medical Center
- Investigators
- Amihai Rottenstreich, MD, Principal investigator, Wolfson Medical CenterIlia Kleiner, MD, Study director, Wolfson Medical CenterNoa Gonen, MD, Study director, Wolfson Medical CenterHagit Eisenberg, MD, Study director, Wolfson Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07820670
- Sponsor's protocol ID
- 0085-25-WOMC
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying the main results will be shared, including: demographics and baseline characteristics; operative/anesthesia details relevant to timing; thrombin-generation parameters (ETP, lag time, peak thrombin); anti-Xa activity (enoxaparin arm); plasma rivaroxaban levels (rivaroxaban arm); ACTS questionnaire scores; adverse events (bleeding/VTE) and follow-up outcomes through 6 weeks postpartum. A data dictionary/codebook will accompany the dataset. Free-text notes and direct identifiers (names, full dates, contact details, MRNs) will not be shared.
Publications
Cano SJ, Lamping DL, Bamber L, Smith S. The Anti-Clot Treatment Scale (ACTS) in clinical trials: cross-cultural validation in venous thromboembolism patients. Health Qual Life Outcomes. 2012 Sep 26;10:120. doi: 10.1186/1477-7525-10-120.
PubMed 23013426Cohen H, Dore CJ, Clawson S, Hunt BJ, Isenberg D, Khamashta M, Muirhead N; RAPS Trial Protocol Collaborators. Rivaroxaban in antiphospholipid syndrome (RAPS) protocol: a prospective, randomized controlled phase II/III clinical trial of rivaroxaban versus warfarin in patients with thrombotic antiphospholipid syndrome, with or without SLE. Lupus. 2015 Sep;24(10):1087-94. doi: 10.1177/0961203315581207. Epub 2015 May 4.
PubMed 25940537Eerenberg ES, Kamphuisen PW, Sijpkens MK, Meijers JC, Buller HR, Levi M. Reversal of rivaroxaban and dabigatran by prothrombin complex concentrate: a randomized, placebo-controlled, crossover study in healthy subjects. Circulation. 2011 Oct 4;124(14):1573-9. doi: 10.1161/CIRCULATIONAHA.111.029017. Epub 2011 Sep 6.
PubMed 21900088Guyatt GH, Akl EA, Crowther M, Gutterman DD, Schuunemann HJ; American College of Chest Physicians Antithrombotic Therapy and Prevention of Thrombosis Panel. Executive summary: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):7S-47S. doi: 10.1378/chest.1412S3. No abstract available.
PubMed 22315257Chan NC, Eikelboom JW, Weitz JI. Evolving Treatments for Arterial and Venous Thrombosis: Role of the Direct Oral Anticoagulants. Circ Res. 2016 Apr 29;118(9):1409-24. doi: 10.1161/CIRCRESAHA.116.306925.
PubMed 27126650Greer IA, Nelson-Piercy C. Low-molecular-weight heparins for thromboprophylaxis and treatment of venous thromboembolism in pregnancy: a systematic review of safety and efficacy. Blood. 2005 Jul 15;106(2):401-7. doi: 10.1182/blood-2005-02-0626. Epub 2005 Apr 5.
PubMed 15811953Stein PD, Hull RD, Kayali F, Olson RE, Alshab AK, Meyers FA, Ghali WA, Silbergleit A, Gibson P. Venous thromboembolism in pregnancy: 21-year trends. Am J Med. 2004 Jul 15;117(2):121-5. doi: 10.1016/j.amjmed.2004.02.021. No abstract available.
PubMed 15234649
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Laboratory Effect of Rivaroxaban Compared to Enoxaparin as Prophylactic Anticoagulant Therapy After Cesarean Section: A Randomized Open-Label Trial
- ClinicalTrials.gov ID
- NCT07820670
- Acronym / sponsor ID
- 0085-25-WOMC
- Keywords
- Rivaroxaban, Enoxaparin, LMWH, DOAC, Thromboprophylaxis, Thrombin Generation, Endogenous Thrombin Potential, Post-cesarean
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 15 Sep 2026 (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.
Pregnancy and the postpartum period increase venous thromboembolism (VTE) risk. After cesarean section, low-molecular-weight heparin (LMWH; enoxaparin) is commonly used for short-term thromboprophylaxis, but it requires daily subcutaneous injections and can cause adverse effects. Direct oral anticoagulants (DOACs) such as rivaroxaban offer convenient once-daily oral dosing. In women who meet institutional criteria for short-term postpartum thromboprophylaxis until hospital discharge, we will compare the laboratory anticoagulant effect of rivaroxaban versus enoxaparin using thrombin generation parameters.
This randomized, open-label trial will enroll women undergoing elective cesarean section who are indicated for in-hospital prophylaxis. Blood will be drawn on postoperative day 2 at trough (pre-dose) and peak (~3 hours post-dose) to measure thrombin generation, anti-Xa activity and drug levels, and participants will complete the Anti-Clot Treatment Scale (ACTS) satisfaction questionnaire. Safety follow-up will occur by telephone at 2 days post-discharge and at 6 weeks postpartum.
Detailed description
Randomized (1:1), open-label, parallel-group, single-center study at Wolfson Medical Center. Eligible participants (Hebrew-speaking, age 18-50, elective cesarean, and meeting local VTE prophylaxis criteria) are randomized to rivaroxaban 10 mg PO once daily or enoxaparin 40 mg SC once daily from the day of surgery until discharge (first dose ≥12 h after cesarean and ≥6 h after spinal anesthesia). On POD2 two blood draws are performed: trough pre-dose and peak ~3 h after dosing. Tests: PT, aPTT, anti-Xa with appropriate calibrators, thrombin generation (endogenous thrombin potential [ETP], lag time, peak thrombin). ACTS (Anti-Clot Treatment Scale (ACTS) satisfaction questionnaire) is administered before discharge. Safety follow-up calls 2 days after discharge and 6 weeks postpartum for bleeding, VTE, allergic reactions or other AEs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rivaroxaban | Experimental | Drug: RivaroxabanParticipants receive rivaroxaban 10 mg orally (PO) once daily, starting ≥12 hours after cesarean delivery and ≥6 hours after spinal anesthesia, and continuing once daily during the index hospitalization until discharge. Standard postpartum care is provided to all participants. |
| Enoxaparin | Active comparator | Drug: Enoxaparin 40 mgParticipants receive enoxaparin 40 mg subcutaneously (SC) once daily, starting ≥12 hours after cesarean delivery and ≥6 hours after spinal anesthesia, and continuing once daily during the index hospitalization until discharge. Standard postpartum care is provided to all participants |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Hebrew-speaking women
- age 18-50
- Elective cesarean at Wolfson
- Indicated for in-hospital thromboprophylaxis per local protocol (need ≥2 risk factors among: cesarean delivery; age >35; BMI >30; parity ≥3; labor duration ≥12 h; postpartum hemorrhage or blood transfusion; reduced mobility)
Key exclusion criteria (15 listed)
- Known thrombophilia
- Prior arterial/venous thrombosis
- Creatinine clearance <29 mL/min
- Abnormal liver enzymes/bilirubin or liver disease
- Coagulation disorders
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 |
|---|---|---|
| RivaroxabanAlso: Xarelto10 mg PO once daily from ≥12 h post-C-section until discharge | Drug | Rivaroxaban |
| Enoxaparin 40 mgAlso: Clexane40 mg SC once daily from ≥12 h post-C-section until discharge | Drug | Enoxaparin |
Primary outcome
Endogenous Thrombin Potential (ETP)
Time frame: Postoperative day 2: immediately before the study drug dose (trough) and approximately 3 hours after the study drug dose (peak), during the index hospitalization
Between-group comparison of ETP to assess similarity of anticoagulant effect; lower ETP indicates greater anticoagulation.
6 secondary outcomes
Thrombin Generation - Lag Time (minutes)
Time frame: Postoperative day 2: immediately before the study drug dose (trough) and approximately 3 hours after the study drug dose (peak), during the index hospitalization
Thrombin Generation - Peak Thrombin (nM)
Time frame: Postoperative day 2: immediately before the study drug dose (trough) and approximately 3 hours after the study drug dose (peak), during the index hospitalization
Anti-Xa activity (IU/mL) - Enoxaparin arm
Time frame: Postoperative day 2: immediately before the enoxaparin dose (trough) and approximately 3 hours after the enoxaparin dose (peak), during the index hospitalization
Plasma Rivaroxaban Concentration (ng/mL) - Rivaroxaban arm
Time frame: Postoperative day 2: immediately before the rivaroxaban dose (trough) and approximately 3 hours after the rivaroxaban dose (peak), during the index hospitalization
Treatment Satisfaction (ACTS Questionnaire total and subscales)
Time frame: Postoperative day 2, prior to hospital discharge
Adverse Events (bleeding and VTE)
Time frame: From randomization through 6 weeks postpartum, including assessment during the index hospitalization, approximately 2 days after discharge, and at 6 weeks postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Results publication: PubMed 23013426Cano SJ, Lamping DL, Bamber L, Smith S. The Anti-Clot Treatment Scale (ACTS) in clinical trials: cross-cultural validation in venous thromboembolism patients. Health Qual Life Outcomes. 2012 Sep 26;10:120. doi: 10.1186/1477-7525-10-120.
- Results publication: PubMed 25940537Cohen H, Dore CJ, Clawson S, Hunt BJ, Isenberg D, Khamashta M, Muirhead N; RAPS Trial Protocol Collaborators. Rivaroxaban in antiphospholipid syndrome (RAPS) protocol: a prospective, randomized controlled phase II/III clinical trial of rivaroxaban versus warfarin in patients with thrombotic antiphospholipid syndrome, with or without SLE. Lupus. 2015 Sep;24(10):1087-94. doi: 10.1177/0961203315581207. Epub 2015 May 4.
- Results publication: PubMed 21900088Eerenberg ES, Kamphuisen PW, Sijpkens MK, Meijers JC, Buller HR, Levi M. Reversal of rivaroxaban and dabigatran by prothrombin complex concentrate: a randomized, placebo-controlled, crossover study in healthy subjects. Circulation. 2011 Oct 4;124(14):1573-9. doi: 10.1161/CIRCULATIONAHA.111.029017. Epub 2011 Sep 6.
- Results publication: PubMed 22315257Guyatt GH, Akl EA, Crowther M, Gutterman DD, Schuunemann HJ; American College of Chest Physicians Antithrombotic Therapy and Prevention of Thrombosis Panel. Executive summary: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):7S-47S. doi: 10.1378/chest.1412S3. No abstract available.
- Results publication: PubMed 27126650Chan NC, Eikelboom JW, Weitz JI. Evolving Treatments for Arterial and Venous Thrombosis: Role of the Direct Oral Anticoagulants. Circ Res. 2016 Apr 29;118(9):1409-24. doi: 10.1161/CIRCRESAHA.116.306925.
- Results publication: PubMed 15811953Greer IA, Nelson-Piercy C. Low-molecular-weight heparins for thromboprophylaxis and treatment of venous thromboembolism in pregnancy: a systematic review of safety and efficacy. Blood. 2005 Jul 15;106(2):401-7. doi: 10.1182/blood-2005-02-0626. Epub 2005 Apr 5.
- Results publication: PubMed 15234649Stein PD, Hull RD, Kayali F, Olson RE, Alshab AK, Meyers FA, Ghali WA, Silbergleit A, Gibson P. Venous thromboembolism in pregnancy: 21-year trends. Am J Med. 2004 Jul 15;117(2):121-5. doi: 10.1016/j.amjmed.2004.02.021. No abstract available.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) underlying the main results will be shared, including: demographics and baseline characteristics; operative/anesthesia details relevant to timing; thrombin-generation parameters (ETP, lag time, peak thrombin); anti-Xa activity (enoxaparin arm); plasma rivaroxaban levels (rivaroxaban arm); ACTS questionnaire scores; adverse events (bleeding/VTE) and follow-up outcomes through 6 weeks postpartum. A data dictionary/codebook will accompany the dataset. Free-text notes and direct identifiers (names, full dates, contact details, MRNs) will not be shared.
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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.
Amihai Rottenstreich, MD principal investigator
Wolfson Medical Center
Ilia Kleiner, MD study director
Wolfson Medical Center
Noa Gonen, MD study director
Wolfson 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 Rivaroxaban and Enoxaparin 40 mg in people with Postpartum Period and Cesarean Section Surgery, run by Wolfson Medical Center at 1 site in Israel.
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 4 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 15 Sep 2026. 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 Israel. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Or Marom, MD (+972-52-554-0490, orr.marom@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endogenous Thrombin Potential (ETP) (time frame: Postoperative day 2: immediately before the study drug dose (trough) and approximately 3 hours after the study drug dose (peak), during the index hospitalization). 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 NCT07820670, which also lists 7 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 15 Sep 2026.