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Tranexamic Acid for the Control of Blood Loss at Elective Cesarean Section

NCT03710330 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2020-08-05

No results posted yet for this study

Summary

The aim of the study is to determine, out of two doses (a standard and a low dose) compared to placebo, the optimal and minimal dose of an intravenously administered single bolus of tranexamic acid(TA) to reduce blood loss when administered during cesarean section(CS). Tranexamic acid is an antifibrinolytic agent, which causes a reversible and competitive blockade of the lysine binding sites on plasminogen molecules. It is a synthetic analog of the amino acid lysine and its action is to reduce blood loss. TA is widely in use in the field of obstetrics. Both antepartum and postpartum hemorrhage(PPH) is being treated by TA extensively. One study demonstrated for the first time that TA administered to women with overt PPH decreases blood loss and maternal morbidity. Prevention of PPH is another indication where TA has been used. Varied doses of TA ranging from 1 mg/kg to more than 100 mg/kg have been used in various surgeries. Even in studies involving CS, the doses used were either a bolus of 1 gm or 10 mg/kg intravenously.

The dose of 1 g or 10 mg/kg is commonly used prophylactically before CS, Because of the lack of data on lower doses and TA pharmacokinetics, a low 0.5-g dose should be tested.

Conditions

  • Cesarean Section Complications

Interventions

DRUG

normal saline

110 ml normal saline IV just before skin incision

DRUG

1gm tranexamic acid

1 gm tranexamic acid (2 ampoules of Capron 500 mg /5 ml; Cairo, Egypt) intravenous just before skin incision

DRUG

0.5 gm tranexamic acid

0.5 gm tranexamic acid (2 ampoules of Capron 500 mg /5 ml; Cairo, Egypt) intravenous just before skin incision

Sponsors & Collaborators

  • Aswan University Hospital

    lead OTHER

Principal Investigators

  • hany f sallam, md · Aswan University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-01
Primary Completion
2020-03-30
Completion
2020-08-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03710330 on ClinicalTrials.gov