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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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PACTR |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
PACTR201203000369163 |
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Date of registration:
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06/03/2012 |
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Primary sponsor: |
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Public title:
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Tranexamic Acid as a haemostatic adjunct to ornipressin during open myomectomy
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Scientific title:
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Tranexamic Acid as a haemostatic adjunct to ornipressin during open myomectomy |
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Date of first enrolment:
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2012-05-01 |
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Target sample size:
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34 |
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Recruitment status: |
Not yet recruiting |
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URL:
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HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201203000369163 |
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Study type:
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interventional |
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Study design:
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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.,
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Countries of recruitment
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South Africa
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Contacts
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Name:
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Obura
Timona |
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Address:
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3rd Paklands Avenue Nairobi
Nairobi
Kenya |
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Telephone:
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0722727772 |
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Email:
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obura.timona@aku.edu |
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Affiliation:
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Associate Professor of Obstetrics and Gynecology and Director of Medical Education |
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Name:
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William
Stones |
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Address:
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3rd Parklands Avenue
Nairobi
Kenya |
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Telephone:
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0734364203 |
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Email:
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stones.william@aku.edu |
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Affiliation:
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Professor and Chair of Obstetrics and Gynecology |
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Key inclusion & exclusion criteria
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Inclusion criteria: 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
Exclusion criteria: Patient without fibroids
Patient with Coagulopathies or treatment with anticoagulants
Patient who declines to give consent
Age minimum:
18 Year
Age maximum:
60 Year
Gender:
Female
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Health Condition(s) or Problem(s) studied
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myomectomy
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Primary Outcome(s)
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Blood loss in each group
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Secondary Outcome(s)
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Duration of surgery
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Hospital stay
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Number of pints transfused
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Source(s) of Monetary Support
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Aga Khan university PGME
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