Tranexamic Acid to Reduce Blood Loss in Hemorrhagic Caesarean Delivery

NCT02797119 | Completed Phase 4

• 3 other identifiers: 2015_132015-002499-26PHRC_2014_0032
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Hemorrhage; Pregnancy Complications

Keywords

Tranexamic acid; Fibrinolysis; Cesarean section; Pharmacokinetics; D dimers; Fibrinogen; Plasmin; Transfusion

Outcome Measures

Primary Outcomes (1)

• 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.

  between inclusion (T0) and 6 hours after inclusion (T360).

Secondary Outcomes (20)

• Postpartum anemia

  at day 2, at day 5

• Postpartum blood loss

  at Day 2

• number of patients presenting with maternal morbidity ie haemostatic interventions and organ failure and ICU admission

  At day 5, At day 42

• Death

  at day 42

• Biological fibrinolysis inhibition

  Between T0 (inclusion) and T360 (6hours later)

Study Arms (4)

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

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

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.

Drug: Saline Solution (TA0)

NH

NO INTERVENTION

To measure the reference fibrinolytic activity in non-hemorrhagic cesarean section

Interventions

tranexamic acid 1 g (TA1) DRUG

1 g standard dose tranexamic acid, intravenous unique bolus over 1 minute

tranexamic acid 1 g (TA1)

tranexamic acid 0.5 g (TA1/2) DRUG

0.5 g standard dose tranexamic acid, intravenous unique bolus over 1 minute

tranexamic acid 0.5 g (TA1/2)

Saline Solution (TA0) DRUG

Saline Solution (TA0)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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,
• intrathecal or intraventricular administration. Obstetrical contraindication to TA
• Patients who participated in a study on the efficacy of an experimental drug in the two month preceding the caesarean section

Sponsors & Collaborators

• University Hospital, Lille: lead
• Ministry of Health, France: collaborator
• French Health Products Safety Agency: collaborator

Study Sites (5)

Hôpital Jeanne de Flandre - CHRU de Lille

Lille, France

Location

Hospices civils de Lyon CHU-Lyon Croix Rousse

Lyon, France

Location

Assistance Publique Hôpitaux Paris Hôpital Louis Mourier

Paris, France

Location

Assistance Publique Hôpitaux Paris Hôpital Trousseau

Paris, France

Location

Centre Hospitalier Maternité Monaco Valenciennes

Valenciennes, France

Location

Related Publications (8)

• 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.

  PMID: 22183066 BACKGROUND

• 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.

  PMID: 36243576 RESULT

• 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.

  PMID: 21496253 RESULT

• 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.

  RESULT

• 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.

  PMID: 23371895 RESULT

• 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.

  PMID: 26258658 RESULT

• 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.

  PMID: 29490690 DERIVED

• 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.

  PMID: 29490682 DERIVED

MeSH Terms

Conditions

Pregnancy Complications; Hemorrhage

Interventions

Tranexamic Acid; Saline Solution

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Anne-Sophie Ducloy-Bouthors, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2016
• First Posted: June 13, 2016
• Study Start: March 15, 2016
• Primary Completion: April 15, 2021
• Study Completion: April 15, 2021
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

FR (5)