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

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

— AEFUTHA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04560465
• Other study ID #: AEFUTHA
• Status: Completed
• Phase: Phase 2
• Start date: June 1, 2018
• Est. completion date: June 1, 2019

Study information

• Verified date: September 2020
• Source: Alex Ekwueme Federal University Teaching Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: June 1, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Nigeria	AEFUTHA	Abakaliki	Ebonyi

Sponsors (1)

Lead Sponsor	Collaborator
Alex Ekwueme Federal University Teaching Hospital

Country where clinical trial is conducted

Nigeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average duration of surgery in each group	Average duration of Surgeries were calculated for each group	one year
Primary	Mean intraoperative Blood loss	The mean intraoperative blood loss was calculated for both groups	one year
Primary	Postoperative Haemoglobin concentration	Average Postoperative Haemoglobin concentration of both groups were determined	one year
Secondary	Blood Transfusion	Risk of Blood Transfusion of both groups were determined	One year