Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201203000369163 Date of Registration: 06/03/2012
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Tranexamic Acid as a haemostatic adjunct to ornipressin during open myomectomy
Official scientific title Tranexamic Acid as a haemostatic adjunct to ornipressin during open myomectomy
Brief summary describing the background and objectives of the trial Haemorrhage during myomectomy is a significant complication requiring urgent intervention, studies done are few informing practice. The proposed study aims at demonstrating whether combining two agents ornipressin and tranexamic acid will translate to blood loss reduction during open myomectomy.Other objectives include duration of surgery , post operative stay and need for blood transfusion
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied myomectomy,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/05/2012
Actual trial start date
Anticipated date of last follow up 31/12/2013
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 34
Recruitment status Not yet recruiting
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 Block randomization of 4 by a computer generated sequence, assigning the intervention drug( tranexamic acid or Saline) The pharmacist preparing the intervention drug or placebo has sealed opaque envelopes containig the prescription of tranexamic acid or placebo, following preparation, the drug is dispensed to a study assistant who delivers it to theatre where the patient is undergoing myomectomy .The surgeon , study assistant and anaesthetist are blinded. Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Tranexamic Acid 1 gram of tranexamic acid in 200ml of normal saline plus (the standard care regime of administering ornipressin 5 international units diluted to 60 ml around the myoma). 20 minutes Tranexamic acid is an anti fibrinolytic agent that acts by blocking the lysine binding site on fibrin where plasminogen would bind to be converted to plasmin subsequently inhibiting fibrinolysis.This ensures clot stabilization and reduces blood loss. 17
Control Group Ornipressin 5 intrenational units diluted to 60 ml Injected around myoma bed Ornipressin (ornithine 8 vasopressin) was introduced in 1971, amino acid ornithine is substituted for arginine at position 8, the basicity of the amino acid at position 8 is what gives it the vasoconstrictive and antidiuretic activity, ornithine being less basic and a short chain amino acid reduces its binding on the distal tubule of the nephron without impairing its binding to vascular smooth mus 17
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patient with documented symptomatic uterine fibroids Written informed consent No prior treatment using GnRh analogues or antagonists No History of bleeding disorder prior use of anticoagulants No prior history of DVT or prothrombotic state Patient without fibroids Patient with Coagulopathies or treatment with anticoagulants Patient who declines to give consent 18 Year(s) 60 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
No 09/03/2012 AKUH ethics committee
Ethics Committee Address
Street address City Postal code Country
3RD AVENUE PARKLANDS Nairobi Box 30270-00100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome Duration of surgery Incision on the uterus up to the time of incision closure
Primary Outcome Blood loss in each group Intra operatve blood loss
Secondary Outcome Number of pints transfused Intra operative and post operative pints administered
Secondary Outcome Hospital stay From the time of extubation to 8am on the day of discharge
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Aga Khan University Hospital Nairobi 3rd Parklands avenue Nairobi Nairobi Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Aga Khan university PGME 3rd Parklands Avenue NAIROBI Box 30270-00100 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor AGA KHAN UNIVERSITY PGME 3rd Parklands avenue Nairobi NAIROBI Box 30270-00100 Kenya University
COLLABORATORS
Name Street address City Postal code Country
Timona Obura 3rd Parklands avenue Nairobi NAIROBI Box 30270-00100 Kenya
William Stones 3rd Parklands avenue Nairobi Nairobi Box 30270-00100 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sammy Ngichabe Kisabuli sammykulova@yahoo.com 0721494460 3rd Paklands Avenue Nairobi
City Postal code Country Position/Affiliation
Nairobi Kenya Resident
Role Name Email Phone Street address
Public Enquiries William Stones stones.william@aku.edu 0734364203 3rd Parklands Avenue
City Postal code Country Position/Affiliation
Nairobi Kenya Professor and Chair of Obstetrics and Gynecology
Role Name Email Phone Street address
Scientific Enquiries Obura Timona obura.timona@aku.edu 0722727772 3rd Paklands Avenue Nairobi
City Postal code Country Position/Affiliation
Nairobi Kenya Associate Professor of Obstetrics and Gynecology and Director of Medical Education
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information