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

Alex Ekwueme Federal University Teaching Hospital

Status and phase: Completed; Phase 2

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

Treatments: Drug: Tranexamic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT04560465

AEFUTHA

Details and patient eligibility

About

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

Full 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.

Enrollment: 59 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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59 participants in 2 patient groups, including a placebo group

group A: Cases that had tranexamic acid infusion

Experimental group

Description:

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

Treatment:

Drug: Tranexamic acid

Group B: Control

Placebo Comparator group

Description:

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

Treatment:

Drug: Tranexamic acid