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

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

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

Study Overview

• Status: Completed
• Conditions: To Determine Efficacy of Tranexamic Acid in Reducing Blood Loss During Myomectomy
• Intervention / Treatment: Drug: Tranexamic acid

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 Type: Interventional
• Enrollment (Actual): 59
• Phase: Phase 2

Contacts and Locations

Study Locations

• Nigeria
  • Ebonyi
    • Abakaliki, Ebonyi, Nigeria, 480213
      • AEFUTHA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group A: Cases that had tranexamic acid infusion; Group A had perioperative tranexamic acid infusion at the rate of 100mls per hour	Drug: 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
Placebo Comparator: Group B: Control; control were given perioperative placebo at the rate of 100mls per hour	Drug: 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Transfusion	Risk of Blood Transfusion of both groups were determined	One year

Collaborators and Investigators

• Sponsor: Alex Ekwueme Federal University Teaching Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): May 31, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: September 18, 2020
• First Submitted That Met QC Criteria: September 18, 2020
• First Posted (Actual): September 23, 2020

Study Record Updates

• Last Update Posted (Actual): September 23, 2020
• Last Update Submitted That Met QC Criteria: September 18, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Tranexamic acid, Myomectomy, Blood loss, Gravimetric
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: AEFUTHA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No