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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04560465
Other study ID # AEFUTHA
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


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