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

NCT03710330 | Completed Phase 4

• 1 other identifier: aswu/276/7/18
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

cesarean section; tranexamic acid; postpartum hemorrhage

Outcome Measures

Primary Outcomes (1)

• intraoperative blood loss

  amount of blood loss during the operation

  during the operation

Secondary Outcomes (3)

• postoperative blood loss

  6 hours post operative

• Number of participants need of uterotonic

  24 hours post operative

• Number of participants need blood transfusion

  24 hours post operative

Study Arms (3)

normal saline

PLACEBO COMPARATOR

the patients receives 110 ml normal saline IV just before skin incision

Drug: normal saline

1gm tranexamic acid

ACTIVE COMPARATOR

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

Drug: 1gm tranexamic acid

0.5 gm tranexamic acid

ACTIVE COMPARATOR

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

Drug: 0.5 gm tranexamic acid

Interventions

normal saline DRUG

110 ml normal saline IV just before skin incision

Also known as: placebo comparator

normal saline

1gm tranexamic acid DRUG

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

Also known as: active comparator

1gm tranexamic acid

0.5 gm tranexamic acid DRUG

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

Also known as: active comparator

0.5 gm tranexamic acid

Eligibility Criteria

• Age: 20 Years - 45 Years
• Gender Eligibility Details: all pregnant women scheduled for elective cesarean
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• Patients with a cardiac, hepatic, renal or thromboembolic disease.
• patients had an allergy to tranexamic acid
• patients who had received platelet antiaggregant such as Aspirin in the week before surgery
• patient refusing to be a participant

Sponsors & Collaborators

• Aswan University Hospital: lead

Study Sites (1)

Aswan University

Aswān, 81528, Egypt

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• hany f sallam, md

  Aswan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The trial will be appropriately blinded; the participants, outcome assessors and the surgeon performing the procedure will be blinded to the medication type, which will be used.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Eligible participants were allocated to one of three groups after induction of general anesthesia and immediately prior to the operation and just before skin incision. Groups were labeled as follows: Group one (120) - 5 ml of distilled water in 20 ml of 5% dextrose Group two (120) - TA in the dose of I gm in 20 ml of 5% dextrose Group three(120) - TA in the dose of 0.5gm in 20 ml of 5% dextrose

Study Record Dates

• First Submitted: October 13, 2018
• First Posted: October 18, 2018
• Study Start: November 1, 2018
• Primary Completion: March 30, 2020
• Study Completion: August 1, 2020
• Last Updated: August 5, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)