NCT01599468

Brief Summary

The purpose of this study was to evaluate the effect of early administration of tranexamic acid (TXA) on post partum hemorrhage caused by uterine atony after cesarean section delivery. This was a randomised, placebo controlled trial including 74 patients. The investigators included ASA1 parturients with correct haemostatic status undergoing cesarean section under spinal anesthesia. The randomization begins after the inefficacy of oxytocin injections and starting up sulprostone perfusion at the request of the surgeon. TXA Group received 10 mg/kg of tranexamic acid as induction dose within 12 minutes and 1mg/Kg/h as maintenance within the 2 following hours. Placebo Group received same volumes of normal saline. The investigators compared blood loss and transfusions in both groups.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2011

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 14, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 16, 2012

Completed
Last Updated

May 22, 2012

Status Verified

May 1, 2012

Enrollment Period

9 months

First QC Date

May 14, 2012

Last Update Submit

May 21, 2012

Conditions

Post Partum Hemorrhage

Keywords

post partum hemorrhagetransfusiontranexamic acid

Outcome Measures

Primary Outcomes (1)

  • volume blood loss

    within 5 days after delivery

Secondary Outcomes (1)

  • transfusion rates.

    within 5 days after delivery

Study Arms (2)

tranexamic acid, post partum hemorrhage

EXPERIMENTAL
Drug: Tranexamic Acid

placebo

PLACEBO COMPARATOR
Drug: saline serum

Interventions

Tranexamic AcidDRUG

10 mg/kg of tranexamic acid as induction dose within 12 minutes and 1mg/Kg/h as maintenance within the 2 following hours

Also known as: exacyl
tranexamic acid, post partum hemorrhage
saline serumDRUG

The Placebo group received normal saline with the same volumes

Also known as: normal saline; NaCl 0.9%
placebo

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ASA1 parturients
  • aged from 20 to 40
  • correct preoperative haemostatic status (prothrombine ratio \> 60 % and platelet rate \> 100 000),
  • cesarean section under spinal anesthesia complicated by uterine atony needing the introduction of Sulprostone

You may not qualify if:

  • abnormal placentation
  • severe pre-eclampsia
  • coagulopathy and uterine rupture
  • the contra indications of TXA : past history of vascular occlusive event, convulsion, and allergy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hedi Chaker University Hospital of Sfax, Department of Anesthesiology and Intensive Care

Sfax, Sfax Governorate, 3029, Tunisia

Location

Related Publications (1)

  • 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: 21496253BACKGROUND

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Tranexamic AcidSaline SolutionSodium Chloride

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • mohamed ayedi

    hedi chaker university hospital of sfax, tunisia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 14, 2012

First Posted

May 16, 2012

Study Start

July 1, 2011

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

May 22, 2012

Record last verified: 2012-05

Locations

TU(1)