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TRAnexamic Acid for Preventing Postpartum Hemorrhage Following a Cesarean Delivery (TRAAP2)

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ClinicalTrials.gov Identifier: NCT03431805
Recruitment Status : Recruiting
First Posted : February 13, 2018
Last Update Posted : May 13, 2019
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Bordeaux

Brief Summary:
The aim is to assess the impact of tranexamic acid (TXA) for preventing postpartum hemorrhage (PPH) following a cesarean section (CS).

Condition or disease Intervention/treatment Phase
Postpartum Hemorrhage Drug: Tranexamic Acid Injectable Solution Drug: Sodium Chloride 0.9% Phase 3

Detailed Description:

Regarding the prevention of PPH, recent randomized controlled trials (RCTs) of unclear quality have suggested that TXA may reduce blood loss and maternal morbidity, while a Cochrane Collaboration review has concluded, that "TXA (in addition to uterotonic medications) decreases postpartum blood loss and prevents PPH and blood transfusions following vaginal birth and CS in women at low risk of PPH based on studies of mixed quality. Further investigations are needed on efficacy and safety of this regimen for preventing PPH.

Treatment, that is a 10-mL blinded vial of the study drug (either 1g TXA or placebo according to the randomization sequence), will be administered intravenously to the participant women during the third stage of labor of cesarean delivery.

The follow-up visit will take place in the postpartum ward of the maternity unit, on D2 postpartum. This stage will include a venous blood sample to measure plasma concentrations of Hb and Ht, urea and creatinemia, prothrombin time (PT), active prothrombin time (aPTT), aspartate and alanine transaminase, total bilirubin and fibrinogen, and the completion of a self-questionnaire about satisfaction by the women, as well as the assessment of the adverse events.

At 8 weeks postpartum, a self-questionnaire assessing psychological status and well-being will be sent to the women. At 12 weeks postpartum, all participants will be contacted by phone to assess the incidence of thrombotic and any other significant events.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4524 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Double blind
Primary Purpose: Prevention
Official Title: TRAnexamic Acid for Preventing Postpartum Hemorrhage Following a Cesarean Delivery :a Multicenter Randomised, Double Blind Placebo Controlled Trial (TRAAP2)
Actual Study Start Date : March 3, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tranexamic acid
intravenous administration of 10-mL of tranexamic acid (EXACYL® 1 g/10 ml I.V., solution injectable)
Drug: Tranexamic Acid Injectable Solution
After the routine and prophylactic administration of a uterotonic , the intervention will be the IV administration of a 10-ml blinded ampoule of the study drug (either TXA or placebo according to the randomisation sequence) to the woman within 3 minutes after birth, slowly (over 30-60 seconds), once the cord has been clamped.

Placebo Comparator: Chloride solution
sodium intravenous administration of 10-mL of chloride solution (0.9% -10mL).
Drug: Sodium Chloride 0.9%
After a routine and prophylactic administration of a uterotonic , the intervention will be the IV administration of a 10-ml blinded ampoule of the study drug (either TXA or placebo according to the randomisation sequence) to the patient within 3 minutes afterbirth), slowly (over 30-60 seconds), once the cord has been clamped.




Primary Outcome Measures :
  1. postpartum hemorrhage [ Time Frame: day 2 ]
    Incidence of PPH defined by a calculated blood loss > 1000mL [Calculated estimated blood loss = estimated blood volume × (preoperative Ht - postoperative Ht)/preoperative Ht (where estimated blood volume (mL) = weight (Kg) × 85)] or red blood cell transfusion up to day 2 postpartum. Preoperative Ht will be the most recent Ht within one week before delivery. Postoperative Ht will be measured at D2


Secondary Outcome Measures :
  1. mean calculated blood loss > 500mL [ Time Frame: day 2 ]
  2. mean calculated blood loss > 1500mL [ Time Frame: day 2 ]
  3. total mean calculated blood loss [ Time Frame: day 2 ]
  4. mean gravimetrically estimated blood loss [ Time Frame: 6 hours ]
    by measuring the suction volume and swab weight; proportion of women requiring supplementary uterotonic treatment including sulprostone

  5. incidence of postpartum transfusion [ Time Frame: day 2 ]
  6. Mean or median number of units of red blood cells transfused [ Time Frame: day 2 ]
  7. incidence of arterial embolisation or emergency surgery for PPH [ Time Frame: 3 months ]
  8. mean peripartum change in haemoglobin [ Time Frame: day 2 ]
    difference between the most recent Hb within one week before delivery and at day 2 postpartum

  9. mean peripartum change in hematocrit [ Time Frame: day 2 ]
    difference between the most recent Ht within one week before delivery and at day 2 postpartum

  10. heart rate [ Time Frame: 15, 30, 45, 60 and 120 minutes after delivery ]
    bpm

  11. diastolic blood pressure [ Time Frame: 15, 30, 45, 60 and 120 minutes after delivery ]
    mmHg

  12. systolic blood pressure [ Time Frame: 15, 30, 45, 60 and 120 minutes after delivery ]
    mmHg

  13. number of participants with nausea reported by caregivers [ Time Frame: 6 hours ]
  14. number of participants with vomiting reported by caregivers [ Time Frame: 6 hours ]
  15. number of participants with phosphenes reported by caregivers [ Time Frame: 6 hours ]
  16. number of participants with dizziness reported by caregivers [ Time Frame: 6 hours ]
  17. creatinemia [ Time Frame: day 2 ]
    micromol/L

  18. urea [ Time Frame: day 2 ]
    g/L

  19. prothrombin time (PT) [ Time Frame: day 2 ]
  20. aspartate transaminase [ Time Frame: day 2 ]
    IU/L

  21. alanine transaminase [ Time Frame: day 2 ]
    IU/L

  22. total bilirubin [ Time Frame: day 2 ]
    micromol/L

  23. total fibrinogen [ Time Frame: day 2 ]
    g/L

  24. number of participants with deep venous thrombosis confirmed by paraclinical exams [ Time Frame: within twelve weeks after the delivery ]
  25. number of participants with pulmonary embolism confirmed by paraclinical exams [ Time Frame: within twelve weeks after the delivery ]
  26. number of participants with myocardial infarction confirmed by paraclinical exams [ Time Frame: within twelve weeks after the delivery ]
  27. number of participants with any thrombotic event confirmed by paraclinical exams [ Time Frame: within twelve weeks after the delivery ]
  28. seizure [ Time Frame: within twelve weeks after the delivery ]
  29. renal failure [ Time Frame: within twelve weeks after the delivery ]
    defined by the need for dialysis

  30. women's satisfaction [ Time Frame: day 2 and weeks 8 postpartum ]
    assessed by a self-administered questionnaire

  31. Provider-assessed clinically significant PPH [ Time Frame: day 2 ]
  32. Hb drop > 2g/DL [ Time Frame: day 2 ]
  33. Active prothrombin time (aPTT) [ Time Frame: day 2 ]
  34. aspartate transaminase > 2N [ Time Frame: day 2 ]
  35. alanine transaminase > 2N (day 2) [ Time Frame: day 2 ]
  36. gravimetrically estimated blood loss > 500mL [ Time Frame: day 2 ]
  37. gravimetrically estimated blood loss > 1000 mL [ Time Frame: day 2 ]
  38. Shock [ Time Frame: day 2 ]
  39. Transfer to Intensive Care Unit [ Time Frame: twelve weeks after delivery ]
  40. Death from any cause [ Time Frame: 42 days postpartum ]
  41. supplementary uterotonic treatment [ Time Frame: day 2 ]
    proportion of women requiring supplementary uterotonic treatment

  42. iron sucrose perfusion [ Time Frame: discharge from hospital ]
    incidence of iron sucrose perfusion

  43. mean gravimetrically estimated blood loss [ Time Frame: at the end of the cesarean delivery ]


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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • : adult women admitted for a cesarean delivery before or during labor, at a term ≥ 34 weeks,
  • hemoglobin level at the last blood sample >9g/dl,
  • available blood test for Hb and Ht within one week before caesarean delivery,
  • informed signed consent

Exclusion Criteria:

  • previous thrombotic event or preexisting 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 and chronic or active liver disease at risk thrombotic or hemorrhagic, autoimmune disease,
  • sickle cell disease,
  • placenta praevia,
  • placenta accreta/increta/percreta,
  • abruption placentae,
  • eclampsia,
  • HELLP syndrome,
  • significant hemorrhage before cesarean section
  • in utero fetal death,
  • administration of low-molecular-weight heparin or antiplatelet agents during the week before delivery,
  • planned general anesthesia,
  • hypersensitivity to tranexamic acid or concentrated hydrochloric acid,
  • instrumental extraction failure,
  • multiple pregnancy with vaginal delivery of the first child,
  • poor understanding of the French language.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03431805


Contacts
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Contact: Loïc Sentilhes, MD,PfD +335 56 79 55 79 loic.sentilhes@chu-bordeaux.fr
Contact: Catherine Deneux-Tharaux, MD + 331 42 34 55 79 catherine.deneux-tharaux@inserm.fr

Locations
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France
CHU Angers Recruiting
Angers, France, 49033
Contact: Guillaume Legendre, MD       guillaume.legendre@chu-angers.fr   
CHU Jean Minjoz Recruiting
Besançon, France, 25000
Contact: Didier Riethmuller, MD,PhD       didier.riethmuller@univ-fcomte.fr   
CHU Bordeaux Recruiting
Bordeaux, France, 33076
Contact: Loic Sentilhes, MD,PhD       loic.sentilhes@chu-bordeaux.fr   
Contact: Olivier delorme       olivier.delorme@chu-bordeaux.fr   
CHU Hôpital Femme Mère Enfant Not yet recruiting
Bron, France, 69677
Contact: Muriel Doret, MD,PhD       muriel.doret-dion@chu-lyon.fr   
CHRU Côte de Nacre Recruiting
Caen, France, 14033
Contact: Delphine Vardon, MD    +336 66 93 52 86    vardon-d@chu-caen.fr   
CHU Estain Recruiting
Clermont Ferrand, France, 63001
Contact: Denis Gallot, MD,PhD       dgallot@chu-clermontferrand.fr   
Centre Hospitalier Intercommunal de Créteil Recruiting
Créteil, France
Contact: Bassam Haddad, MD       bassam.haddad@chicreteil.fr   
Hôpital Saint Joseph Marseille Recruiting
Marseille, France, 13008
Contact: Raoul Desbrières, MD       raoul.desbriere@orange.fr   
Hopital Nord Recruiting
Marseille, France, 13915
Contact: Florence Bretelle, MD,PhD       florence.bretelle@ap-hm.fr   
CHU de Montpellier Recruiting
Montpellier, France, 34295
Contact: Florent Fuchs, MD       f-fuchs@chu-montpellier.fr   
CHRU de Nancy Recruiting
Nancy, France, 54000
Contact: Olivier Morel, MD,PhD       olivier.morel@chru-nancy.fr   
CHU Nantes Recruiting
Nantes, France, 44093
Contact: Norbert Winer, MD,PhD       norbert.winer@chu-nantes.fr   
CHU Nice Not yet recruiting
Nice, France, 06202
Contact: André Bongain, MD,PhD       bongain.a@chu-nice.fr   
CHU Nîmes Recruiting
Nîmes, France, 30900
Contact: Vincent Letouzey, MD,PhD       vincent.letouzey@chu-nimes.fr   
Hôpital Trousseau Recruiting
Paris, France, 75012
Contact: Gilles Kayem, MD,PhD       gkayem@gmail.com   
Hôpital Saint Joseph Paris Recruiting
Paris, France, 75014
Contact: Elie Azria, MD       eazria@hpsj.fr   
Maternité de Port-Royal Paris Recruiting
Paris, France, 75014
Contact: François Goffinet, MD,PhD       francois.goffinet@aphp.fr   
Hôpital universitaire Necker-Enfants malades Recruiting
Paris, France, 75015
Contact: Laurent Salomon, MD,PhD       laurentsalomon@gmail.com   
Hôpital universitaire Robert Debré Recruiting
Paris, France, 75019
Contact: Thomas Schmitz, MD,PhD       thomas.schmitz@aphp.fr   
Hôpital Lariboisière Paris Recruiting
Paris, France, 75475
Contact: Jeremy Sroussi, MD       jeremy.sroussi@aphp.fr   
Hôpital universitaire Kremlin-Bicètre Recruiting
Paris, France, 94270
Contact: Marie Victoire Senat, MD,PhD       marie-victoire.senat@aphp.fr   
CH de Pau Recruiting
Pau, France
Contact: Caroline BOHEC, MD       caroline.bohec@ch-pau.fr   
Centre Hospitalier Intercommunal Poissy-Saint Germain Recruiting
Poissy, France, 78303
Contact: Patrick Rozenberg, MD,PhD       prozenberg@chi-poissy-st-germain.fr   
CHU Rennes Recruiting
Rennes, France, 35033
Contact: Hélène Isly, MD,PhD       helene.isly@chu-rennes.fr   
Principal Investigator: Maela Le Lous, MD         
CHU Charles Nicolle Recruiting
Rouen, France, 76000
Contact: Eric Verspyck, MD,PhD       Eric.Verspyck@chu-rouen.fr   
CHU Saint Etienne Recruiting
Saint Etienne, France, 42270
Contact: Céline Chauleur, MD,PhD       celine.chauleur@chu-st-etienne.fr   
CHU Strasbourg Recruiting
Strasbourg, France, 67098
Contact: Nicolas Sananes, MD       Nicolas.SANANES@chru-strasbourg.fr   
Contact: Bruno Langer, MD, PhD       Bruno.Langer@chru-strasbourg.fr   
Hôpital Paule de Viguier CHU Toulouse Recruiting
Toulouse, France, 31059
Contact: Paul Guerby, MD       guerby.p@chu-toulouse.fr   
CHU Tours Recruiting
Tours, France, 37044
Contact: Franck Perrotin, MD,PhD       franck.perrotin@med.univ-tours.fr   
Sponsors and Collaborators
University Hospital, Bordeaux
Ministry of Health, France

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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT03431805     History of Changes
Other Study ID Numbers: CHUBX 2015/41
First Posted: February 13, 2018    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Bordeaux:
Randomized
double blind placebo controlled trial
prevention
tranexamic acid
postpartum hemorrhage
cesarean

Additional relevant MeSH terms:
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Hemorrhage
Postpartum Hemorrhage
Uterine Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Pharmaceutical Solutions
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants