Efficacy of Tranexamic Acid in Reducing Myomectomy Associated Blood Loss in Federal Teaching Hospital Abakaliki.

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2019-06-01

Brief Summary

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to determine safety and efficacy of Tranexamic Acid in reducing blood loss during Myomectomy in our institution.

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Detailed Description

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A double blinded randomized controlled trial in which cases were given 1000mg intravenous tranexamic acid into 1L of intravenous normal saline and control were given 10mls of placebo water for injection into same amount of intravenous fluid. outcome of both groups in terms of intraoperative blood loss, duration of surgery, postoperative packed cell volume and total blood loss with risk of blood transfusion were then determined.

Conditions

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To Determine Efficacy of Tranexamic Acid in Reducing Blood Loss During Myomectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

two groups comprising of cases and control

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

double blind

Study Groups

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group A: Cases that had tranexamic acid infusion

Group A had perioperative tranexamic acid infusion at the rate of 100mls per hour

Group Type EXPERIMENTAL

Tranexamic acid

Intervention Type DRUG

intravenous perioperative tranexamic acid was added into infusion of normal saline for the cases while placebo of intravenous water for injection was added into normal saline perioperatively for control

Group B: Control

control were given perioperative placebo at the rate of 100mls per hour

Group Type PLACEBO_COMPARATOR

Tranexamic acid

Intervention Type DRUG

intravenous perioperative tranexamic acid was added into infusion of normal saline for the cases while placebo of intravenous water for injection was added into normal saline perioperatively for control

Interventions

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Tranexamic acid

intravenous perioperative tranexamic acid was added into infusion of normal saline for the cases while placebo of intravenous water for injection was added into normal saline perioperatively for control

Intervention Type DRUG