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Completed

NCT Number: NCT04560465

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.

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Key information

Conditions

To Determine Efficacy of Tranexamic Acid in Reducing Blood Loss During Myomectomy Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

AEFUTHA

Abakaliki, Ebonyi State, 480213, Nigeria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tranexamic Acid

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

Primary outcomes

  1. Average duration of surgery in each group

    Time frame: one year

    Average duration of Surgeries were calculated for each group

  2. Mean intraoperative Blood loss

    Time frame: one year

    The mean intraoperative blood loss was calculated for both groups

  3. Postoperative Haemoglobin concentration

    Time frame: one year

    Average Postoperative Haemoglobin concentration of both groups were determined

Secondary outcomes

  1. Blood Transfusion

    Time frame: One year

    Risk of Blood Transfusion of both groups were determined

Sponsors and collaborators

Lead sponsor

Alex Ekwueme Federal University Teaching Hospital

Other

Registry information

Official study title

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

Acronym: AEFUTHA

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 23, 2020
Registry last updated
Sep 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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