Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202312679640849 Date of Approval: 28/12/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A Randomized Comparison Of Tranexamic Acid And Tourniquet Versus Tourniquet For The Reduction Of Blood Loss During Abdominal Myomectomy In Enugu Nigeria.
Official scientific title Comparison of Tranexamic acid and Tourniquet versus Tourniquet for the reduction of blood loss during abdominal myomectomy in Enugu, Nigeria. A randomised control study
Brief summary describing the background and objectives of the trial Haemostatic agents (tranexamic acid), and conventional tourniquet have been used among other techniques for the reduction of hemorrhage during open myomectomies. There is limited evidence that a combination of tranexamic acid and tourniquet may further reduce bleeding during myomectomy. Objectives: To compare blood loss in reproductive age women that received intravenous tranexamic acid plus tourniquet versus tourniquet and placebo during open abdominal myomectomy in Enugu, Nigeria.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Uterine fibroid
Purpose of the trial Prevention
Anticipated trial start date 02/01/2024
Actual trial start date
Anticipated date of last follow up 01/05/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 114
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Tranexamic acid and Tourniquet group 1g of intravenous tranexamic acid by slow intravenous infusion over 10 minutes, 20 minutes before the skin incision, and another 25mg/kg/day in 3 divided doses each in 1litre of normal saline for 24hours after the surgery at the rate of 40 drops per minute. 20 minutes before skin incision up to 24 hours post-toperatively Eligible participant allocated to group A (tranexamic acid group together with tourniquet), received 1g of intravenous tranexamic acid by slow intravenous infusion over 10 minutes, 20 minutes before the skin incision, and another 25mg/kg/day in 3 divided doses each in 1litre of normal saline for 24hours after the surgery at the rate of 40 drops per minute (Trexam, (PROTECH) brand of tranexamic acid was used in this study). 57
Control Group Tourniquet and Placebo alone group 10 mls of water for injection. received 10mls of water for injection by slow intravenous infusion over 10 minutes, 20 minutes before the skin incision, and another 10mls of water for injection 8hrly each in 1litre of normal saline for 24hours after the surgery at the rate of 40 drops per minute 20 minutes before skin incision up to 24 hours postoperatively The control group received tourniquet with placebo (sterile water). As soon as access was gained into the peritoneal cavity, a general inspection was done, the uterus was lifted out of the pelvic cavity and a thorough inspection of the uterus, fallopian tubes and the ovaries were carried out. A size 24-gauge Foley catheter that was provided for each participant was applied at the base of the uterus close to the insertion of uterosacral ligament this was made tight by the application of strong Kochers forceps anteriorly. This temporally impeded the blood supply from the uterine and ovarian artery. And this was be released every 30minutes to prevent irreversible ischaemic injury to the uterus 57 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Women in reproductive age with symptomatic uterine fibroid, booked for open abdominal myomectomy at the study centers were recruited for this study. Women with the following history and co-morbid conditions were excluded from the study. 1. Patients with history of myomectomy in the past, 2. Use of GnRH analog before surgery 3. Allergy to the use of tranexamic acid 4. Thromboembolic disorders 5. Renal impairment 6. Obese (weight >30kg/m2) Adult: 19 Year-44 Year 18 Year(s) 45 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 20/03/2023 University of Nigeria Teaching Hospital Enugu Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Ituku-Ozalla, Enugu Enugu 400001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Mean estimated volume of intra-operative blood loss in milliliter in the study and control groups Intraoperatively
Secondary Outcome 1. Mean estimated volume of total blood loss in milliliter in both study group and control group. 2. Mean difference between pre-operative and post-operative haemoglobin in g/dl for study and control groups 3. The average number of pints of blood transfused per participant in both groups. Intraoperatively and postoperatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Nigeria Teaching Hospital ituku Ozalla. Ituku ozalla Enugu Nigeria
Enugu State University Teaching Hospital Parklane Enugu Nigeria
Mother of Christ Specialist Hospital Enugu Ogui Road beside Holy Ghost cathedral Enugu Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Self funding Ituku-Ozalla Enugu Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor DR. AMULU IFEANYI VICTOR Ituku-Ozalla Enugu Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator VICTOR AMULU ifeanyiamulu@yahoo.com +2348033867382 Ituku-Ozalla
City Postal code Country Position/Affiliation
Enugu Nigeria Senior Specialist Registrar Department of Obstetrics and Gynaecology University of Nigeria Teaching Hospital Enugu Nigeria
Role Name Email Phone Street address
Public Enquiries George Eleje georgel21@yahoo.com +234806811744 Old onitsha road
City Postal code Country Position/Affiliation
Nnewi Nigeria Consultant Obstetrician and Gynaecologist Department of OBGYN Nnamdi Azikiwe University Teaching Hospital Nnewi Nigeria
Role Name Email Phone Street address
Scientific Enquiries Chigozie Okafor chigolz@yahoo.com +2348034802657 Old Onitsha Road
City Postal code Country Position/Affiliation
Nnewi 435101 Nigeria Consultant Obstetrician and Gynaecologist Department of Obstetrics and Gynaecology Nnamdi Azikiwe University Teaching Hospital Nnewi Nigeria
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Study Protocol Immediately following publication, No end date Not applicable
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information