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

Phase 2

Completed

• Conditions: To Determine Efficacy of Tranexamic Acid in Reducing Blood Loss During Myomectomy
• Interventions: Drug: Tranexamic acid

• Registration Number: NCT04560465
• Lead Sponsor: Alex Ekwueme Federal University Teaching Hospital

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2018-06-01
• Primary Completion: 2019-05-31
• Study Completion: 2019-06-01
• Status Verified: 2020-09
• Study First Submitted: 2020-09-18
• Study First Submitted QC: 2020-09-18
• Last Update Submitted: 2020-09-18
• Study First Posted: 2020-09-23
• Last Update Posted: 2020-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 59

Inclusion Criteria

• non-pregnant women with symptomatic myomas women with no known contraindication to tranexamic acid

Exclusion Criteria

• past history of thromboembolic disorder, ischaemic heart disease, malignancy or liver disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group A: Cases that had tranexamic acid infusion	Tranexamic acid	Group A had perioperative tranexamic acid infusion at the rate of 100mls per hour
Group B: Control	Tranexamic acid	control were given perioperative placebo at the rate of 100mls per hour

Primary Outcome Measures

Name	Time	Method
Postoperative Haemoglobin concentration	one year	Average Postoperative Haemoglobin concentration of both groups were determined
Average duration of surgery in each group	one year	Average duration of Surgeries were calculated for each group
Mean intraoperative Blood loss	one year	The mean intraoperative blood loss was calculated for both groups

Secondary Outcome Measures

Name	Time	Method
Blood Transfusion	One year	Risk of Blood Transfusion of both groups were determined

Trial Locations

Locations (1)

AEFUTHA; 🇳🇬 Abakaliki, Ebonyi, Nigeria