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.: PACTR202404508588938 Date of Approval: 24/04/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title effectiveness of intravenous tranexamic acid and pericervical touniquette i reducing blood loss in open abdominal myomectomy
Official scientific title A randomized control trial of the effect of intravenous tranexamic acid and pericervical tourniquet on peri-operative blood loss in open abdominal myomectomy .
Brief summary describing the background and objectives of the trial Uterine fibroid is the commonest gynaecological tumour, with a prevalence of 70% to 80% in women who have reached the age of 50years. The incidence is higher in Negroid women. Abnormal uterine bleeding is one of the commonest modes of presentation with studies reporting a high incidence of anaemia in women with uterine fibroid who presented with menorrhagia. Open abdominal myomectomy is the most common treatment option in our environment,This study assessed the effectiveness of intravenous tranexamic acid in reducing blood loss when used as an adjunct to peri-cervical tourniquet during open abdominal myomectomy
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Genetic Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/06/2023
Actual trial start date 01/07/2023
Anticipated date of last follow up 31/12/2023
Actual Last follow-up date 31/12/2023
Anticipated target sample size (number of participants) 36
Actual target sample size (number of participants) 36
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group intravenous tranexamic acid 1gram, 10minutes The drug will be administered slowly at 1grm in double dilution as a clear fluid intra-op following induction of anesthesia. An anti fibrinolytic agent 18
Control Group normal saline 20mls 10minutes administration of 20mls normal saline intra-op as placebo 18 Placebo
Experimental Group tranexamic acid as antifibrinolytic drug 1g slowly start, at induction of anesthesia 24hours 1gram tranwexamic acid colourless 18
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
all fibroid size between 12 to 24weeks coagulopathy, repeat myomectomy, reaction to the drug 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 23/05/2023 BDTH HREC
Ethics Committee Address
Street address City Postal code Country
LAFIYA ROAD kaduna 800212 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome level of blood loss intraoperatively
Secondary Outcome mean blood transfusion rate intraoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
baraudikko teaching hospital kaduna lafiya road kaduna 800001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
lubabatu malali kaduna 800001 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor lubabatu malali kaduna 800001 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mujtaba abdulrasheed mujtaba@yahoo.com +2348035991853 zaria
City Postal code Country Position/Affiliation
kaduna 800001 Nigeria srenior lecturer
Role Name Email Phone Street address
Public Enquiries muhammad salisu muhd379037@gmail.com +2348037139707 malali
City Postal code Country Position/Affiliation
kaduna 800001 Nigeria senior leturer
Role Name Email Phone Street address
Scientific Enquiries ibrahim abdulrasheed ibrahim4abdul@gmail.com +2348032582022 kurminmashi
City Postal code Country Position/Affiliation
kaduna 800001 Nigeria lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes data to be shared will be Individual participant data that underlie the results reported in the article, after deidentification[text,tables,figures,and appendices], the data will be available post publication no end date to anyone who wishes to access the data.for any purpose. Analyses type could be for individual meta analysis.Data will be available indefinitely at bdth.kdsg.gov.ng Clinical Study Report,Informed Consent Form 3months phone/email
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