Pregnancy ComplicationsPhase 4TRACESNCT02797119

Tranexamic Acid to Reduce Blood Loss in Hemorrhagic Caesarean Delivery

A Phase 4 study testing tranexamic acid 1 g (TA1), tranexamic acid 0.5 g (TA1/2) and Saline Solution (TA0) in people with Pregnancy Complications and Hemorrhage, run by University Hospital, Lille at 5 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 60 years, women onlyHealthy volunteers can take part
Conditions the study is for: Pregnancy Complications, Hemorrhage
What is being tested?: tranexamic acid 1 g (TA1), tranexamic acid 0.5 g (TA1/2) and Saline Solution (TA0)
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 225 participants
Where: 5 sitesFrance
Study dates: 15 Mar 2016to 15 Apr 2021
Phase: Phase 4
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 60 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Experimental group: Each patient
experiencing a bleeding volume of more than 800 mL
due to surgery or to atony uterine
during an elective or non-emergent caesarean section
secondary post-partum haemorrhage after caesarean section, even if CS has been emergent
after complete information and consent signature.

Show all 11Show fewer

covered by social security. Reference non-hemorrhagic group: Each patient
experiencing a bleeding volume of strictly less than 800 mL
during an elective or emergent caesarean section
after complete information and consent signature.
covered by social security.

Who cannot join

Patient unable to consent (<18 years old or incapable people and specially protected mentioned in the article L1121-5 to L1121-8) RCP medical contraindication to tranexamic acid such as
Hypersensibility to the product or excipient,
Previous or ongoing arterial or venous thrombosis,
Coagulopathy, except DIC associated with a predominant fibrinolytic profile,
Renal failure,
Previous seizures,

Show all 12Show fewer

intrathecal or intraventricular administration. Obstetrical contraindication to TA
Severe HELLP syndrome (platelet count <50 000/m3 or renal failure prior to the caesarean (RIFLE score>2) Protocol related contraindication to inclusion
Administration of TA before inclusion-Inherited haemorrhagic diseases and low molecular weight heparin within 24 hours before inclusion
Patients who participated in a study on the efficacy of an experimental drug in the two month preceding the caesarean section
Inherited haemorrhagic diseases or low molecular weight heparin within 24 hours before inclusion
Previous inclusion in an interventional trial since the 2 months before CS

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

France5 sites

Hôpital Jeanne de Flandre - CHRU de Lille
Lille
Hospices civils de Lyon CHU-Lyon Croix Rousse
Lyon
Assistance Publique Hôpitaux Paris Hôpital Louis Mourier
Paris
Assistance Publique Hôpitaux Paris Hôpital Trousseau
Paris
Centre Hospitalier Maternité Monaco Valenciennes
Valenciennes

Other trials in France

About this study

Official title: Tranexamic Acid to Reduce Blood Loss in Hemorrhagic Caesarean Delivery: a Multicenter Randomized Double Blind Placebo Controlled Therapeutic and Pharmaco-biological Dose Ranging Study (TRACES) for Its Optimal Benefit/Risk

TRACES trial is a multicenter randomized double blind placebo control therapeutic and pharmaco-biological dose ranging study to measure the effect on blood loss reduction of a single intravenous infusion of two doses regimens (standard dose and low dose) of TA administered at the onset of an active PPH (>800mL) during elective or non-emergent CS and to correlate this clinical effect with the biological effect of fibrinolysis inhibition and the pharmacodynamic measure of TA uterine bleeding and venous blood concentration.

Read the detailed description

Postpartum hemorrhage (PPH) is the leading cause of maternal death. Tranexamic acid (TA) (Exacyl® Sanofi France), an antifibrinolytic drug, reduces bleeding and transfusion need in major surgery and trauma (1). In ongoing PPH following vaginal delivery (2), a high dose of TA decreased the volume and duration of PPH, the transfusion need and the maternal morbidity, while early fibrinolysis was inhibited (3). Prophylactic use of TA limited the postoperative bleeding in elective non hemorrhagic caesarean section (CS). (1, 4) TA efficiency in the hemorrhagic caesarean context has not been previously published.

TA doses range vary from 2,5 to 100 mg/kg and side effects were observed with the largest doses.(1,4) Pharmacokinetics old data concerned non hemorrhagic patients.(1) WOMAN ongoing international trial using a one gram dose have a mortality reduction objective.(5) The optimal dose for ongoing caesarean PPH has to be determined.

Aim of the study:

The aim of the multicenter randomized double blind placebo control therapeutic and pharmaco-biological dose ranging study TRACES is to measure the effect on blood loss reduction of a single intravenous infusion of two doses regimens of TA administered at the onset of an active PPH (>800mL) during elective or non-emergent CS and to correlate this clinical effect with the biological effect of fibrinolysis inhibition and the pharmacodynamic measure of TA uterine bleeding and venous blood concentration.

Statistical method:

The sample size computation is based on the expected difference between the placebo group and the low dose. On the base of EXADELI trial results, the investigators calculated that a total of 342 subjects (114 per group) is required, For the main objective, the blood loss volume measured in each experimental group (low dose and high dose) will be compared to that of the placebo group by using an analysis of covariance adjusted for baseline blood loss volume. In cases of non-normal distribution, relative blood loss volume will be calculated and compared using a Mann-Whitney U test. Analyses will be done on an intention-to-treat basis and all statistical tests will be performed with a 2-tailed alpha risk of 0.05. The sample size computation for the pharmaco-biological substudy have been calculated regarding the inhibition of fibrinolysis (D Dimers increase between 30 and 120 minutes negative or null (EXADELI trial 11)). The NNS for this substudy is 48 patients in each of the 3 hemorrhagic groups and 48 patients in the reference non-hemorrhagic group for a total of 192 patients. These substudy hemorrhagic patients will be selected from the experimental groups as the first 144 patients for which the TA concentration and plasmin peak specific sampling will be completed regarding the blood collection and congelation organisation in each center.

Expected research benefit:

The project is aimed to answer for a current clinical practice question: Timing and dose of TA to reduce blood loss and maternal morbidity due to active hemorrhage during CS in order to determine the optimal and minimal TA dose to obtain the better efficacy and the limitations of side-effects.

Conditions: Pregnancy Complications, Hemorrhage
Being tested: tranexamic acid 1 g (TA1), tranexamic acid 0.5 g (TA1/2), Saline Solution (TA0)
Keywords: Tranexamic acid, Fibrinolysis, Cesarean section, Pharmacokinetics, D dimers, Fibrinogen, Plasmin, Transfusion
Medical subject headings: Pregnancy Complications, Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

tranexamic acid 1 g (TA1)Drug
1 g standard dose tranexamic acid, intravenous unique bolus over 1 minute
tranexamic acid 0.5 g (TA1/2)Drug
0.5 g standard dose tranexamic acid, intravenous unique bolus over 1 minute
Saline Solution (TA0)Drug

Study groups in NCT02797119
Study group	Role	What they receive
tranexamic acid 1 g (TA1)	Experimental	To measure the efficacy of a standard 1g dose TA to reduce blood loss in ongoing hemorrhagic cesarean section. To correlate this clinical effect with the fibrinolysis inhibition and the TA venous and uterine blood concentration Receives: Drug: tranexamic acid 1 g (TA1)
tranexamic acid 0.5 g (TA1/2)	Experimental	To measure the efficacy of a low 0,5g dose TA to reduce blood loss in ongoing hemorrhagic cesarean section To correlate this clinical effect with the fibrinolysis inhibition and the TA venous and uterine blood concentration Receives: Drug: tranexamic acid 0.5 g (TA1/2)
Saline Solution (TA0)	Placebo comparator	To measure the evolution of blood loss without TA in ongoing hemorrhagic cesarean section To correlate this clinical evolution with fibrinolysis. Receives: Drug: Saline Solution (TA0)
NH	No intervention	To measure the reference fibrinolytic activity in non-hemorrhagic cesarean section

What is being measured

The primary outcome is the main question the study is designed to answer.

Bleeding
Bleeding will be strictly measured (mL) in aspiration or cell salvage bags (substraction of the amniotic fluid if needed) and drapes weighting at each time point.
Measured: between inclusion (T0) and 6 hours after inclusion (T360).

Secondary outcomes (20)

Postpartum anemia
Measured: at day 2, at day 5
Postpartum blood loss
Measured: at Day 2
number of patients presenting with maternal morbidity ie haemostatic interventions and organ failure and ICU admission
Measured: At day 5, At day 42
Death
Measured: at day 42
Biological fibrinolysis inhibition
Percentage of patients for which D Dimers increase is blunted.
Measured: Between T0 (inclusion) and T360 (6hours later)
Urinary urea and Creatinuria on timed diuresis
Urinary Urea (g/L) and creatinuria (mg/L) are measured on a timed urinary sample : collected from the bladder catheter, initial diuresis at the beginning of CS is thrown out at the time of inclusion. A strict measure of urinary volume is made at T120, a sample of one monovette of urines is done to get the concentration of urea, creatinuria and tranexamic acid and their ratio and then thrown out. The same process is done on the urinary volume collected between T120 and T360.
Measured: Between T0 (inclusion) and T360 (6hours later)
the number of patients developing an oliguria or a renal failure (RIFLE score more than 2)
Diuresis is measured on a timed urinary sample : collected from the bladder catheter, initial diuresis at the beginning of CS is thrown out at the time of inclusion. A strict measure of urinary volume is made at T120 and T360. Oliguria is defined as a diuresis less than 180mL per 6 hours. Urea (g/L) and creatininemia (mg/L) are measured at T0 inclusion and T360, 6 hours later. the number of patients developping an oliguria or a renal failure (RIFLE score more than 2) is collected.
Measured: Between T0 (inclusion) and T360 (6hours later)
Deep vein thrombosis or pulmonary embolism
Number of patient developing a deep vein thrombosis or pulmonary embolism clinically diagnosed and confirmed by echodoppler for DVT and angiosccanner for PE. Data collected from the clinical follow up since hospital discharge and a phone call at D42 +/- 10 days
Measured: Between T0 (inclusion) and Day 42
Seizures
Number of patient developing a seizure clinically diagnosed
Measured: Between T0 (inclusion) and Day 42
Visual disturbances
Number of patient developing a colours' visual disturbance clinically diagnosed. Data collected from the clinical follow up since hospital discharge and a phone call at D42 +/- 10 days.
Measured: Between T0 (inclusion) and Day 42
Nausea
Number of patient developing nausea clinically diagnosed and needing a treatment. Data collected from the clinical follow up since hospital discharge and a phone call at D42 +/- 10 days.
Measured: Between T0 (inclusion) and Day 42
Peak Plasma Concentration (Cmax) in venous blood
Venous blood sampled on a dedicated catheter. Biological assessment using Van Geffen method for thrombin and plasmin direct measurement in a weill. Plasmin inhibition.
Measured: Between T0 (inclusion) and T360 (6hours after inclusion)
Area under the plasma concentration versus time curve (AUC) in venous blood
Venous blood sampled on a dedicated catheter. Biological assessment using Van Geffen method for thrombin and plasmin direct measurement in a weill.
Measured: Between T0 (inclusion) and T360 (6hours after inclusion)
Lagtime between thrombin and plasmin peaks (s) in venous blood
Venous blood sampled on a dedicated catheter. Biological assessment using Van Geffen method for thrombin and plasmin direct measurement in a weill.
Measured: Between T0 (inclusion) and T360 (6hours after inclusion)
Peak Plasma Concentration (Cmax) in uterine bleeding
Uterine bleeding sampled by obstetrician in placental bed and after hysterotomy is closed, collected vaginally. Biological assessment using Van Geffen method for thrombin and plasmin direct measurement in a weill.
Measured: Between T0 (inclusion) and T360 (6hours after inclusion)
Area under the plasma concentration versus time curve (AUC) in uterine bleeding
Uterine bleeding sampled by obstetrician in placental bed and after hysterotomy is closed, collected vaginally. Biological assessment using Van Geffen method for thrombin and plasmin direct measurement in a weill.
Measured: Between T0 (inclusion) and T360 (6hours after inclusion)
Lagtime between thrombin and plasmin peaks (s) in uterine bleeding
Uterine bleeding sampled by obstetrician in placental bed and after hysterotomy is closed, collected vaginally. Biological assessment using Van Geffen method for thrombin and plasmin direct measurement in a weill.
Measured: Between T0 (inclusion) and T360 (6hours after inclusion)
Tranexamic acid plasma concentration
Venous blood sampled on a dedicated catheter. Biological assessment using direct plasma drug concentration (mg/L) measurement.
Measured: Between T0 (inclusion) and T360 (6hours after inclusion)
Tranexamic acid concentration in uterine bleeding
Uterine bleeding sampled by obstetrician in placental bed and after hysterotomy is closed, collected vaginally. Biological assessment using direct plasma drug concentration (mg/L) measurement.
Measured: Between T0 (inclusion) and T360 (6hours after inclusion)
Tranexamic acid urinary excretion
Tranexamic acid concentration (mg/L) is measured parallely to urinary urea (g/L) and creatinuria (mg/L) on a timed urinary sample : collected from the bladder catheter, initial diuresis at the beginning of CS is thrown out at the time of inclusion. A strict measure of urinary volume is made at T120, a sample of one monovette of urines is done to get the concentration of urea, creatinuria and tranexamic acid and their ratio and then thrown out. The same process is done on the urinary volume collected between T120 and T360.
Measured: Between T0 (inclusion) and T360 (6hours after inclusion)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Mar 201615 Apr 2021

First posted13 Jun 2016 (estimated)
Study start15 Mar 2016
Primary completion15 Apr 2021
Study completion15 Apr 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Pregnancy ComplicationsStudies of the same condition, open and under way.
More trials run by University Hospital, LilleThe 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 225 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02797119
Sponsor's protocol ID: 2015_13
Other IDs: 2015-002499-26, PHRC_2014_0032, 2015
Acronym: TRACES
Status last verified: Apr 2026
First submitted: 17 May 2016
Last updated: 21 Apr 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

van Geffen M, Loof A, Lap P, Boezeman J, Laros-van Gorkom BA, Brons P, Verbruggen B, van Kraaij M, van Heerde WL. A novel hemostasis assay for the simultaneous measurement of coagulation and fibrinolysis. Hematology. 2011 Nov;16(6):327-36. doi: 10.1179/102453311X13085644680348.
PubMed 22183066
Ducloy-Bouthors AS, Gilliot S, Kyheng M, Faraoni D, Turbelin A, Keita-Meyer H, Rigouzzo A, Moyanotidou G, Constant B, Broisin F, Gouez AL, Favier R, Peynaud E, Ghesquiere L, Lebuffe G, Duhamel A, Allorge D, Susen S, Hennart B, Jeanpierre E, Odou P; TRACES working group. Tranexamic acid dose-response relationship for antifibrinolysis in postpartum haemorrhage during Caesarean delivery: TRACES, a double-blind, placebo-controlled, multicentre, dose-ranging biomarker study. Br J Anaesth. 2022 Dec;129(6):937-945. doi: 10.1016/j.bja.2022.08.033. Epub 2022 Oct 13.
PubMed 36243576
Ducloy-Bouthors AS, Jude B, Duhamel A, Broisin F, Huissoud C, Keita-Meyer H, Mandelbrot L, Tillouche N, Fontaine S, Le Goueff F, Depret-Mosser S, Vallet B; EXADELI Study Group; Susen S. High-dose tranexamic acid reduces blood loss in postpartum haemorrhage. Crit Care. 2011;15(2):R117. doi: 10.1186/cc10143. Epub 2011 Apr 15.
PubMed 21496253
Anne-Sophie Ducloy-Bouthors, Alain Duhamel, Antoine Tournoys, Annabelle, Gisele Debize, Edith Peneau, Brigitte Jude, Benoit Vallet, Dominique De Prost, Cyril Huissoud, Sophie Susen., Hyperfibrinolysis and post-partum haemorrhage induced coagulopathy. 2013, Thrombosis research Volume 131, Supplement S88-89. Accepted BJA-2014-00923.
Goobie SM, Meier PM, Sethna NF, Soriano SG, Zurakowski D, Samant S, Pereira LM. Population pharmacokinetics of tranexamic acid in paediatric patients undergoing craniosynostosis surgery. Clin Pharmacokinet. 2013 Apr;52(4):267-76. doi: 10.1007/s40262-013-0033-1.
PubMed 23371895
Rozen L, Faraoni D, Sanchez Torres C, Willems A, Noubouossie DC, Barglazan D, Van der Linden P, Demulder A. Effective tranexamic acid concentration for 95% inhibition of tissue-type plasminogen activator induced hyperfibrinolysis in children with congenital heart disease: A prospective, controlled, in-vitro study. Eur J Anaesthesiol. 2015 Dec;32(12):844-50. doi: 10.1097/EJA.0000000000000316.
PubMed 26258658
Ducloy-Bouthors AS, Jeanpierre E, Saidi I, Baptiste AS, Simon E, Lannoy D, Duhamel A, Allorge D, Susen S, Hennart B. TRAnexamic acid in hemorrhagic CESarean section (TRACES) randomized placebo controlled dose-ranging pharmacobiological ancillary trial: study protocol for a randomized controlled trial. Trials. 2018 Mar 1;19(1):149. doi: 10.1186/s13063-017-2421-6.
PubMed 29490690
Bouthors AS, Hennart B, Jeanpierre E, Baptiste AS, Saidi I, Simon E, Lannoy D, Duhamel A, Allorge D, Susen S. Therapeutic and pharmaco-biological, dose-ranging multicentre trial to determine the optimal dose of TRAnexamic acid to reduce blood loss in haemorrhagic CESarean delivery (TRACES): study protocol for a randomised, double-blind, placebo-controlled trial. Trials. 2018 Mar 1;19(1):148. doi: 10.1186/s13063-017-2420-7.
PubMed 29490682

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Tranexamic Acid to Reduce Blood Loss in Hemorrhagic Caesarean Delivery: a Multicenter Randomized Double Blind Placebo Controlled Therapeutic and Pharmaco-biological Dose Ranging Study (TRACES) for Its Optimal Benefit/Risk
ClinicalTrials.gov ID: NCT02797119
Acronym / sponsor ID: TRACES / 2015_13
Conditions: Pregnancy Complications, Hemorrhage
Keywords: Tranexamic acid, Fibrinolysis, Cesarean section, Pharmacokinetics, D dimers, Fibrinogen, Plasmin, Transfusion
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 225 participants (actual)
Lead sponsor: University Hospital, LilleUniversity, hospital or other
Collaborators: Ministry of Health, France, French Health Products Safety Agency
Study start: 15 Mar 2016 (actual)
Primary completion: 15 Apr 2021 (actual)
Study completion: 15 Apr 2021 (actual)
First posted: 13 Jun 2016 (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.

Detailed description

Aim of the study:

Statistical method:

Expected research benefit:

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
tranexamic acid 1 g (TA1)	Experimental	Drug: tranexamic acid 1 g (TA1)To measure the efficacy of a standard 1g dose TA to reduce blood loss in ongoing hemorrhagic cesarean section. To correlate this clinical effect with the fibrinolysis inhibition and the TA venous and uterine blood concentration
tranexamic acid 0.5 g (TA1/2)	Experimental	Drug: tranexamic acid 0.5 g (TA1/2)To measure the efficacy of a low 0,5g dose TA to reduce blood loss in ongoing hemorrhagic cesarean section To correlate this clinical effect with the fibrinolysis inhibition and the TA venous and uterine blood concentration
Saline Solution (TA0)	Placebo comparator	Drug: Saline Solution (TA0)To measure the evolution of blood loss without TA in ongoing hemorrhagic cesarean section To correlate this clinical evolution with fibrinolysis.
NH	No intervention	–To measure the reference fibrinolytic activity in non-hemorrhagic cesarean section

Who may qualify

Ages: 18 to 60 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (11 listed)

Experimental group: Each patient
experiencing a bleeding volume of more than 800 mL
due to surgery or to atony uterine
during an elective or non-emergent caesarean section
secondary post-partum haemorrhage after caesarean section, even if CS has been emergent

Key exclusion criteria (12 listed)

Patient unable to consent (<18 years old or incapable people and specially protected mentioned in the article L1121-5 to L1121-8) RCP medical contraindication to tranexamic acid such as
Hypersensibility to the product or excipient,
Previous or ongoing arterial or venous thrombosis,
Coagulopathy, except DIC associated with a predominant fibrinolytic profile,
Renal failure,

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
tranexamic acid 1 g (TA1)1 g standard dose tranexamic acid, intravenous unique bolus over 1 minute	Drug	tranexamic acid 1 g (TA1)
tranexamic acid 0.5 g (TA1/2)0.5 g standard dose tranexamic acid, intravenous unique bolus over 1 minute	Drug	tranexamic acid 0.5 g (TA1/2)
Saline Solution (TA0)	Drug	Saline Solution (TA0)

Primary outcome

Bleeding
Time frame: between inclusion (T0) and 6 hours after inclusion (T360).
Bleeding will be strictly measured (mL) in aspiration or cell salvage bags (substraction of the amniotic fluid if needed) and drapes weighting at each time point.

20 secondary outcomes

Postpartum anemia
Time frame: at day 2, at day 5
Postpartum blood loss
Time frame: at Day 2
number of patients presenting with maternal morbidity ie haemostatic interventions and organ failure and ICU admission
Time frame: At day 5, At day 42
Death
Time frame: at day 42
Biological fibrinolysis inhibition
Time frame: Between T0 (inclusion) and T360 (6hours later)
Urinary urea and Creatinuria on timed diuresis
Time frame: Between T0 (inclusion) and T360 (6hours later)
the number of patients developing an oliguria or a renal failure (RIFLE score more than 2)
Time frame: Between T0 (inclusion) and T360 (6hours later)
Deep vein thrombosis or pulmonary embolism
Time frame: Between T0 (inclusion) and Day 42
Seizures
Time frame: Between T0 (inclusion) and Day 42
Visual disturbances
Time frame: Between T0 (inclusion) and Day 42
Nausea
Time frame: Between T0 (inclusion) and Day 42
Peak Plasma Concentration (Cmax) in venous blood
Time frame: Between T0 (inclusion) and T360 (6hours after inclusion)
Area under the plasma concentration versus time curve (AUC) in venous blood
Time frame: Between T0 (inclusion) and T360 (6hours after inclusion)
Lagtime between thrombin and plasmin peaks (s) in venous blood
Time frame: Between T0 (inclusion) and T360 (6hours after inclusion)
Peak Plasma Concentration (Cmax) in uterine bleeding
Time frame: Between T0 (inclusion) and T360 (6hours after inclusion)
Area under the plasma concentration versus time curve (AUC) in uterine bleeding
Time frame: Between T0 (inclusion) and T360 (6hours after inclusion)
Lagtime between thrombin and plasmin peaks (s) in uterine bleeding
Time frame: Between T0 (inclusion) and T360 (6hours after inclusion)
Tranexamic acid plasma concentration
Time frame: Between T0 (inclusion) and T360 (6hours after inclusion)
Tranexamic acid concentration in uterine bleeding
Time frame: Between T0 (inclusion) and T360 (6hours after inclusion)
Tranexamic acid urinary excretion
Time frame: Between T0 (inclusion) and T360 (6hours after inclusion)

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 21 Apr 2026.
Background: PubMed 22183066van Geffen M, Loof A, Lap P, Boezeman J, Laros-van Gorkom BA, Brons P, Verbruggen B, van Kraaij M, van Heerde WL. A novel hemostasis assay for the simultaneous measurement of coagulation and fibrinolysis. Hematology. 2011 Nov;16(6):327-36. doi: 10.1179/102453311X13085644680348.
Results publication: PubMed 36243576Ducloy-Bouthors AS, Gilliot S, Kyheng M, Faraoni D, Turbelin A, Keita-Meyer H, Rigouzzo A, Moyanotidou G, Constant B, Broisin F, Gouez AL, Favier R, Peynaud E, Ghesquiere L, Lebuffe G, Duhamel A, Allorge D, Susen S, Hennart B, Jeanpierre E, Odou P; TRACES working group. Tranexamic acid dose-response relationship for antifibrinolysis in postpartum haemorrhage during Caesarean delivery: TRACES, a double-blind, placebo-controlled, multicentre, dose-ranging biomarker study. Br J Anaesth. 2022 Dec;129(6):937-945. doi: 10.1016/j.bja.2022.08.033. Epub 2022 Oct 13.
Results publication: PubMed 21496253Ducloy-Bouthors AS, Jude B, Duhamel A, Broisin F, Huissoud C, Keita-Meyer H, Mandelbrot L, Tillouche N, Fontaine S, Le Goueff F, Depret-Mosser S, Vallet B; EXADELI Study Group; Susen S. High-dose tranexamic acid reduces blood loss in postpartum haemorrhage. Crit Care. 2011;15(2):R117. doi: 10.1186/cc10143. Epub 2011 Apr 15.
Results publicationAnne-Sophie Ducloy-Bouthors, Alain Duhamel, Antoine Tournoys, Annabelle, Gisele Debize, Edith Peneau, Brigitte Jude, Benoit Vallet, Dominique De Prost, Cyril Huissoud, Sophie Susen., Hyperfibrinolysis and post-partum haemorrhage induced coagulopathy. 2013, Thrombosis research Volume 131, Supplement S88-89. Accepted BJA-2014-00923.
Results publication: PubMed 23371895Goobie SM, Meier PM, Sethna NF, Soriano SG, Zurakowski D, Samant S, Pereira LM. Population pharmacokinetics of tranexamic acid in paediatric patients undergoing craniosynostosis surgery. Clin Pharmacokinet. 2013 Apr;52(4):267-76. doi: 10.1007/s40262-013-0033-1.
Results publication: PubMed 26258658Rozen L, Faraoni D, Sanchez Torres C, Willems A, Noubouossie DC, Barglazan D, Van der Linden P, Demulder A. Effective tranexamic acid concentration for 95% inhibition of tissue-type plasminogen activator induced hyperfibrinolysis in children with congenital heart disease: A prospective, controlled, in-vitro study. Eur J Anaesthesiol. 2015 Dec;32(12):844-50. doi: 10.1097/EJA.0000000000000316.
Derived from this study: PubMed 29490690Ducloy-Bouthors AS, Jeanpierre E, Saidi I, Baptiste AS, Simon E, Lannoy D, Duhamel A, Allorge D, Susen S, Hennart B. TRAnexamic acid in hemorrhagic CESarean section (TRACES) randomized placebo controlled dose-ranging pharmacobiological ancillary trial: study protocol for a randomized controlled trial. Trials. 2018 Mar 1;19(1):149. doi: 10.1186/s13063-017-2421-6.
Derived from this study: PubMed 29490682Bouthors AS, Hennart B, Jeanpierre E, Baptiste AS, Saidi I, Simon E, Lannoy D, Duhamel A, Allorge D, Susen S. Therapeutic and pharmaco-biological, dose-ranging multicentre trial to determine the optimal dose of TRAnexamic acid to reduce blood loss in haemorrhagic CESarean delivery (TRACES): study protocol for a randomised, double-blind, placebo-controlled trial. Trials. 2018 Mar 1;19(1):148. doi: 10.1186/s13063-017-2420-7.
Individual participant dataSharing planned: Undecided

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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.

Anne-Sophie Ducloy-Bouthors, MD principal investigator

University Hospital, Lille

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 11 inclusion and 12 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 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Bleeding (time frame: between inclusion (T0) and 6 hours after inclusion (T360).). 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 NCT02797119, which also lists 8 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 21 Apr 2026.