Can Tranexamic Acid Reduce Bleeding After Post Partum Hemorrhage in Cesarean Section Delivery
NCT ID: NCT01599468
Last Updated: 2012-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
74 participants
INTERVENTIONAL
2011-07-31
2012-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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tranexamic acid, post partum hemorrhage
Tranexamic Acid
10 mg/kg of tranexamic acid as induction dose within 12 minutes and 1mg/Kg/h as maintenance within the 2 following hours
placebo
saline serum
The Placebo group received normal saline with the same volumes
Interventions
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Tranexamic Acid
10 mg/kg of tranexamic acid as induction dose within 12 minutes and 1mg/Kg/h as maintenance within the 2 following hours
saline serum
The Placebo group received normal saline with the same volumes
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* severe pre-eclampsia
* coagulopathy and uterine rupture
* the contra indications of TXA : past history of vascular occlusive event, convulsion, and allergy.
20 Years
40 Years
FEMALE
No
Sponsors
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Hédi Chaker Hospital
OTHER
Responsible Party
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mohamed ayedi
Principal Investigator
Principal Investigators
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mohamed ayedi
Role: PRINCIPAL_INVESTIGATOR
hedi chaker university hospital of sfax, tunisia
Locations
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Hedi Chaker University Hospital of Sfax, Department of Anesthesiology and Intensive Care
Sfax, Sfax Governorate, Tunisia
Countries
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References
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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.
Other Identifiers
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TXA-1
Identifier Type: -
Identifier Source: org_study_id
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