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

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

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.

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

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

Intervention / Treatment
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* Drug: Tranexamic acid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: two groups comprising of cases and control
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tranexamic acid, Myomectomy, Blood loss, Gravimetric