Back to resultsEfficacy of Tranexamic Acid in Reducing Myomectomy Associated Blood Loss in Federal Teaching Hospital Abakaliki. (AEFUTHA)
Primary Purpose
To Determine Efficacy of Tranexamic Acid in Reducing Blood Loss During Myomectomy
Status
Completed
Phase
Phase 2
Locations
Nigeria
Study Type
Interventional
Intervention
Tranexamic acid
Sponsored by
About this trial
This is an interventional treatment trial for To Determine Efficacy of Tranexamic Acid in Reducing Blood Loss During Myomectomy focused on measuring Tranexamic acid, Myomectomy, Blood loss, Gravimetric
Eligibility Criteria
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
Sites / Locations
- AEFUTHA
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
group A: Cases that had tranexamic acid infusion
Group B: Control
Arm Description
Group A had perioperative tranexamic acid infusion at the rate of 100mls per hour
control were given perioperative placebo at the rate of 100mls per hour
Outcomes
Primary Outcome Measures
Average duration of surgery in each group
Average duration of Surgeries were calculated for each group
Mean intraoperative Blood loss
The mean intraoperative blood loss was calculated for both groups
Postoperative Haemoglobin concentration
Average Postoperative Haemoglobin concentration of both groups were determined
Secondary Outcome Measures
Blood Transfusion
Risk of Blood Transfusion of both groups were determined
Full Information
NCT ID
NCT04560465
First Posted
September 18, 2020
Last Updated
September 18, 2020
Sponsor
Alex Ekwueme Federal University Teaching Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04560465
Brief Title
Efficacy of Tranexamic Acid in Reducing Myomectomy Associated Blood Loss in Federal Teaching Hospital Abakaliki.
Acronym
AEFUTHA
Official Title
Efficacy of Tranexamic Acid in Reducing Myomectomy Associated Blood Loss in Federal Teaching Hospital Abakaliki
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
May 31, 2019 (Actual)
Study Completion Date
June 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alex Ekwueme Federal University Teaching Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
to determine safety and efficacy of Tranexamic Acid in reducing blood loss during Myomectomy in our institution.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
To Determine Efficacy of Tranexamic Acid in Reducing Blood Loss During Myomectomy
Keywords
Tranexamic acid, Myomectomy, Blood loss, Gravimetric
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
two groups comprising of cases and control
Masking
ParticipantCare ProviderInvestigator
Masking Description
double blind
Allocation
Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group A: Cases that had tranexamic acid infusion
Arm Type
Experimental
Arm Description
Group A had perioperative tranexamic acid infusion at the rate of 100mls per hour
Arm Title
Group B: Control
Arm Type
Placebo Comparator
Arm Description
control were given perioperative placebo at the rate of 100mls per hour
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid
Intervention Description
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 Outcome Measure Information:
Title
Average duration of surgery in each group
Description
Average duration of Surgeries were calculated for each group
Time Frame
one year
Title
Mean intraoperative Blood loss
Description
The mean intraoperative blood loss was calculated for both groups
Time Frame
one year
Title
Postoperative Haemoglobin concentration
Description
Average Postoperative Haemoglobin concentration of both groups were determined
Time Frame
one year
Secondary Outcome Measure Information:
Title
Blood Transfusion
Description
Risk of Blood Transfusion of both groups were determined
Time Frame
One year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
AEFUTHA
City
Abakaliki
State/Province
Ebonyi
ZIP/Postal Code
480213
Country
Nigeria
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Tranexamic Acid in Reducing Myomectomy Associated Blood Loss in Federal Teaching Hospital Abakaliki.
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