Postpartum HemorrhageBIO-TRAAPNCT03742947
Haemostasis and Tranexamic Acid in Caesarean Delivery
A study testing peripartum haemostasis in people with Postpartum Hemorrhage and Hyperfibrinolysis, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
The aim of the study is to evaluate haemostasis and fibrinolysis in peripartum of caesarean delivery and the effect of tranexamic acid (TXA) given in prevention of post-partum haemorrhage (PPH). Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Postpartum Hemorrhage, Hyperfibrinolysis
- What is being tested?
- peripartum haemostasis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jan 2019to 17 Jan 2020
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient randomized into TRAAP2 study (NCT03431805):
- adult women admitted for a planned caesarean delivery,
- at term ≥ 34 weeks,
- haemoglobin level at the last blood sample >9g/dl,
- blood Formula numbering within 7 days before caesarean delivery, informed signed consent)
- informed signed consent for BIO-TRAAP
Who cannot join
- patient not included into TRAAP2 study:
- previous thrombotic event or pre-existing pro-thrombotic disease,
- epileptic state or history of seizures,
- presence of any chronic or active cardiovascular disease outside hypertension,
- any chronic or active renal disease including renal, chronic or acute insufficiency (glomerular flow <90mL / min), and chronic or active liver disease at risk thrombotic or haemorrhagic,
- autoimmune disease,
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- sickle cell disease,
- placenta praevia,
- placenta accreta/increta/percreta,
- abruption placentae,
- eclampsia,
- HELLP syndrome,
- in utero fetal death,
- administration of low-molecular-weight heparin or antiplatelet agents during the week before delivery,
- general anaesthesia,
- hypersensitivity to tranexamic acid or concentrated hydrochloric acid, instrumental extraction failure,
- multiple pregnancy with genital delivery of the first twin and caesarean delivery for the second or at third trimester,
- poor understanding of the French language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Peripartum Haemostasis and Effects of Tranexamic Acid in Caesarean Delivery: Biologic Ancillary Study in TRAAP2 Patients Recruited at the Bordeaux University Hospital: BIO-TRAAP
The aim of the study is to evaluate haemostasis and fibrinolysis in peripartum of caesarean delivery and the effect of tranexamic acid (TXA) given in prevention of post-partum haemorrhage (PPH).
Read the detailed description
Post-partum haemorrhage (PPH) remains a leading cause of maternal morbidity and mortality. Haemostasis and fibrinolysis are activated in peripartum. Fibrinolysis is decreased during pregnancy, is quickly activated after childbirth and can be overactivated in case of PPH. Tranexamic acid (TXA), an antifibrinolytic drug, has been proven to efficiently decrease bleeding and death in PPH. Its place in prevention of PPH after caesarean section remains to be established. The aim of the study protocol TRAAP2 is to conduct a large multicentre randomized, double blind placebo-controlled trial to adequately assess the impact of TXA for preventing PPH following a caesarean section. Peripartum is also a period of increased thrombo-embolic risk. TXA has never been proven to increase thromboembolic events. Nevertheless, it seems important to reserve TXA for women with activated fibrinolysis.
The aim of the ancillary biologic study BIO-TRAAP is thus to explore haemostasis and fibrinolysis in peripartum, to determine which women will in the future benefit from TXA. Fibrinolysis will be studied by clot lysis time by Global Fibrinolytic Capacity test on the Lysis Timer (GFC/LT), t-PA, PAI-1, PAI-2, euglobulin clot lysis time, plasminogen, plasmin-anti-plasmin complex, thrombin-anti-thrombin complex, fibrin degradation products (FDP).
- Conditions
- Postpartum Hemorrhage, Hyperfibrinolysis
- Being tested
- peripartum haemostasis
- Keywords
- ancillary biologic study, fibrinolysis, tranexamic acid, post-partum haemorrhage
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peripartum haemostasisDiagnostic test
Three blood samples of 20 ml each at T0 after the anaesthesia for the caesarean section and before the administration of the product (TXA or placebo), T15 fifteen minutes after the administration of the product and T120, 2 hours after the administration of the product.
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid | Experimental | intravenous administration of 10-mL of tranexamic acid (EXACYL® 1 g/10 ml I.V., solution injectable) Receives: Diagnostic Test: peripartum haemostasis |
| Chloride solution | Placebo comparator | sodium intravenous administration of 10-mL of chloride solution (0.9% -10mL) Receives: Diagnostic Test: peripartum haemostasis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clot lysis time
Clot lysis time in minutes studied by the Global Fibrinolytic Capacity on the Lysis Timer
Measured: Baseline (defined as the time of insertion of the peripheric venous line)
Secondary outcomes (20)
Lysis Timer clot lysis time
Clot lysis time in minutes studied by the Global Fibrinolytic Capacity on the Lysis Timer
Measured: Time 15min and Time 120min (defined as 15 minutes 120 minutes after the administration of the product, respectively)
Routine clot lysis time
Clot lysis time in minutes studied by the routine biological tests
Measured: Baseline, Time 15min, and Time 120min
t-PA
tissue-Plasminogen Activator (ng/ml)
Measured: Baseline, Time 15min, and Time 120min
PAI-1
Plasminogen activator inhibitor-1 (ng/ml)
Measured: Baseline, Time 15min, and Time 120min
PAI-2
Plasminogen activator inhibitor-2 (ng/ml)
Measured: Baseline, Time 15min, and Time 120min
Euglobulin clot lysis time
Euglobulin clot lysis time (min),
Measured: Baseline, Time 15min, and Time 120min
Plasminogen
Plasminogen (%)
Measured: Baseline, Time 15min, and Time 120min
Hb
Hemoglobin (g/dl)
Measured: Baseline, Time 15min, and Time 120min
Platelets
Platelets (G/l)
Measured: Baseline, Time 15min, and Time 120min
TP
Prothrombin ratio (%)
Measured: Baseline, Time 15min, and Time 120min
aPTT ratio
Activated Cephalin Time (sec)
Measured: Baseline, Time 15min, and Time 120min
Fibrinogen
Fibrinogen (g/l)
Measured: Baseline, Time 15min, and Time 120min
Fibrin degradation products
Fibrin degradation products (µg/l)
Measured: Baseline, Time 15min, and Time 120min
Plasmin-antiplasmin complex
Plasmin-antiplasmin complex (µg/l)
Measured: Baseline, Time 15min, and Time 120min
Thrombin-antithrombin complex
Thrombin-antithrombin complex (ng/ml)
Measured: Baseline, Time 15min, and Time 120min
Bleeding
Bleeding (ml)
Measured: Baseline, Time 15min, and Time 120min
Transfusion of packs of red blood cells
Number of packs of red blood cells
Measured: Time 120min
Transfusion of platelet concentrates
Number of platelet concentrates
Measured: Time 120min
Transfusion of plasma
volume of plasma (ml)
Measured: Time 120min
Transfusion of fibrinogen concentrate
Amount (g) of fibrinogen concentrate
Measured: Time 120min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study start10 Jan 2019
- Primary completion17 Jan 2020
- Study completion17 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum HemorrhageStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- 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
- Model description
- Three blood samples of 20 ml each at T0 after the anesthesia for the caesarean section and before the administration of the product (TXA or placebo), T15 fifteen minutes after the administration of the product and T120, 2 hours after the administration of TRAAP2 study IMP (tranexamic acid or placebo).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Bordeaux Association for Training and Research in Obstetric Gynecology, Association of Anesthesiologists and Intensivists of Vascular Surgery and Transplantation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03742947
- Sponsor's protocol ID
- CHUBX 2018/24
- Other IDs
- 2018-A01838-47
- Acronym
- BIO-TRAAP
- Status last verified
- Apr 2020
- First submitted
- 30 Oct 2018
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Roullet S, Rivoire T, Houssin C, Labrouche S, Paquin S, Nouette-Gaulain K, Deneux-Tharaux C, Amiral J, James C, Sentilhes L. Hemostatic Effects of Tranexamic Acid in Cesarean Delivery: An Ancillary Study of the TRAAP2 Study. Thromb Haemost. 2022 Nov;122(11):1869-1878. doi: 10.1055/s-0042-1755379. Epub 2022 Sep 8.
PubMed 36075235
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Peripartum Haemostasis and Effects of Tranexamic Acid in Caesarean Delivery: Biologic Ancillary Study in TRAAP2 Patients Recruited at the Bordeaux University Hospital: BIO-TRAAP
- ClinicalTrials.gov ID
- NCT03742947
- Acronym / sponsor ID
- BIO-TRAAP / CHUBX 2018/24
- Conditions
- Postpartum Hemorrhage, Hyperfibrinolysis
- Keywords
- ancillary biologic study, fibrinolysis, tranexamic acid, post-partum haemorrhage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Bordeaux Association for Training and Research in Obstetric Gynecology, Association of Anesthesiologists and Intensivists of Vascular Surgery and Transplantation
- Study start
- 10 Jan 2019 (actual)
- Primary completion
- 17 Jan 2020 (actual)
- Study completion
- 17 Jan 2020 (actual)
- First posted
- 15 Nov 2018 (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.
The aim of the study is to evaluate haemostasis and fibrinolysis in peripartum of caesarean delivery and the effect of tranexamic acid (TXA) given in prevention of post-partum haemorrhage (PPH).
Detailed description
Post-partum haemorrhage (PPH) remains a leading cause of maternal morbidity and mortality. Haemostasis and fibrinolysis are activated in peripartum. Fibrinolysis is decreased during pregnancy, is quickly activated after childbirth and can be overactivated in case of PPH. Tranexamic acid (TXA), an antifibrinolytic drug, has been proven to efficiently decrease bleeding and death in PPH. Its place in prevention of PPH after caesarean section remains to be established. The aim of the study protocol TRAAP2 is to conduct a large multicentre randomized, double blind placebo-controlled trial to adequately assess the impact of TXA for preventing PPH following a caesarean section. Peripartum is also a period of increased thrombo-embolic risk. TXA has never been proven to increase thromboembolic events. Nevertheless, it seems important to reserve TXA for women with activated fibrinolysis.
The aim of the ancillary biologic study BIO-TRAAP is thus to explore haemostasis and fibrinolysis in peripartum, to determine which women will in the future benefit from TXA. Fibrinolysis will be studied by clot lysis time by Global Fibrinolytic Capacity test on the Lysis Timer (GFC/LT), t-PA, PAI-1, PAI-2, euglobulin clot lysis time, plasminogen, plasmin-anti-plasmin complex, thrombin-anti-thrombin complex, fibrin degradation products (FDP).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Three blood samples of 20 ml each at T0 after the anesthesia for the caesarean section and before the administration of the product (TXA or placebo), T15 fifteen minutes after the administration of the product and T120, 2 hours after the administration of TRAAP2 study IMP (tranexamic acid or placebo).
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid | Experimental | Diagnostic Test: peripartum haemostasisintravenous administration of 10-mL of tranexamic acid (EXACYL® 1 g/10 ml I.V., solution injectable) |
| Chloride solution | Placebo comparator | Diagnostic Test: peripartum haemostasissodium intravenous administration of 10-mL of chloride solution (0.9% -10mL) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- patient randomized into TRAAP2 study (NCT03431805):
- informed signed consent for BIO-TRAAP
Key exclusion criteria (18 listed)
- patient not included into TRAAP2 study:
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 |
|---|---|---|
| peripartum haemostasisThree blood samples of 20 ml each at T0 after the anaesthesia for the caesarean section and before the administration of the product (TXA or placebo), T15 fifteen minutes after the administration of the product and T120, 2 hours after the administration of the product. | Diagnostic test | Chloride solution, Tranexamic acid |
Primary outcome
Clot lysis time
Time frame: Baseline (defined as the time of insertion of the peripheric venous line)
Clot lysis time in minutes studied by the Global Fibrinolytic Capacity on the Lysis Timer
20 secondary outcomes
Lysis Timer clot lysis time
Time frame: Time 15min and Time 120min (defined as 15 minutes 120 minutes after the administration of the product, respectively)
Routine clot lysis time
Time frame: Baseline, Time 15min, and Time 120min
t-PA
Time frame: Baseline, Time 15min, and Time 120min
PAI-1
Time frame: Baseline, Time 15min, and Time 120min
PAI-2
Time frame: Baseline, Time 15min, and Time 120min
Euglobulin clot lysis time
Time frame: Baseline, Time 15min, and Time 120min
Plasminogen
Time frame: Baseline, Time 15min, and Time 120min
Hb
Time frame: Baseline, Time 15min, and Time 120min
Platelets
Time frame: Baseline, Time 15min, and Time 120min
TP
Time frame: Baseline, Time 15min, and Time 120min
aPTT ratio
Time frame: Baseline, Time 15min, and Time 120min
Fibrinogen
Time frame: Baseline, Time 15min, and Time 120min
Fibrin degradation products
Time frame: Baseline, Time 15min, and Time 120min
Plasmin-antiplasmin complex
Time frame: Baseline, Time 15min, and Time 120min
Thrombin-antithrombin complex
Time frame: Baseline, Time 15min, and Time 120min
Bleeding
Time frame: Baseline, Time 15min, and Time 120min
Transfusion of packs of red blood cells
Time frame: Time 120min
Transfusion of platelet concentrates
Time frame: Time 120min
Transfusion of plasma
Time frame: Time 120min
Transfusion of fibrinogen concentrate
Time frame: Time 120min
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 14 May 2026.
- Results publication: PubMed 36075235Roullet S, Rivoire T, Houssin C, Labrouche S, Paquin S, Nouette-Gaulain K, Deneux-Tharaux C, Amiral J, James C, Sentilhes L. Hemostatic Effects of Tranexamic Acid in Cesarean Delivery: An Ancillary Study of the TRAAP2 Study. Thromb Haemost. 2022 Nov;122(11):1869-1878. doi: 10.1055/s-0042-1755379. Epub 2022 Sep 8.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing peripartum haemostasis in people with Postpartum Hemorrhage and Hyperfibrinolysis, run by University Hospital, Bordeaux at 1 site in France.
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 18 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 14 May 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 France. 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. Some participants in this study may receive a placebo. 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?
Clot lysis time (time frame: Baseline (defined as the time of insertion of the peripheric venous line)). 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 NCT03742947, which also lists 1 linked publication.
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 14 May 2026.