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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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SLCTR |
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Last refreshed on:
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27 May 2013 |
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Main ID: |
SLCTR/2007/008 |
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Date of registration:
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12/06/2007 |
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Primary sponsor: |
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Public title:
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International study of bleeding after injury
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Scientific title:
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Clinical Randomization of an Antifibrinolytic agent in Significant Haemorrhage |
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Date of first enrolment:
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1/4/2007 |
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Target sample size:
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20000 patients around the world |
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Recruitment status: |
Completed |
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URL:
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http://www.slctr.lk/trial_details.asp?reg_id={89CEE364-D6E9-4305-816A-EB81B5B24F85} |
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Study type:
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Interventional |
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Study design:
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Doubled blind controlled randomization
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Countries of recruitment
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Albania,Argentina,Australia,Belgium,Cameroon,Canada,Colombia,Cuba,Czech Republic,Ecuador,Egypt,Georgia,India,Indonesia,Iran,Iraq,Italy,Japan,Malaysia,Mexico,Nigeria,Peru,Saudi Arabia,Serbia and Montenegro,Singapore,Slovakia,SA,Thailand,Tunisia,UK
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Contacts
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Name:
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Dr. R.N. Ellawala
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Address:
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Accident Service , National Hospital of Sri Lanka, Colombo
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Telephone:
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+ 94(0)777316933 |
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Email:
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ranjithellawala@yahoo.com |
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Affiliation:
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Consultant Surgeon |
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Name:
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Ms Haleema Shakur
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Address:
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LSHTM, Keppel Street, London WC1E 7HT, UK
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Telephone:
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+44(0)20 7958 8113 |
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Email:
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Haleema.Shakur@Lshtm.ac.uk |
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Affiliation:
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Trials Manager |
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Key inclusion & exclusion criteria
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Inclusion criteria: All patients whose age is 16 yrs old or above with significant haemorrhage following trauma.( systolic blood pressure 90 mm hg and / or heart rate is more than 110/ min.) within 8 hours of injury
Exclusion criteria: Patient who requires tranexamic acid as a treatment or its use is contraindicated
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Haemorrhage following trauma
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Intervention(s)
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Loading dose of Tranexamic acid or placebo 1 grm. in 100 ml of 0.9% NaCL over 10 min. followed by 1 grm. of tranexamic acid or placebo over 8 hrs duluted in 0.9% NaCL 240 ml
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Primary Outcome(s)
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Death in hospital within 4 weeks of injury
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Secondary Outcome(s)
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Receipt of a blood products transfusion, the number of units of blood products transfused, surgical intervention and the occurrence of thrombo- embolic episodes
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Secondary ID(s)
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Protocol number ISRCTN86750102, EudraCT 2004-002955-14
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Source(s) of Monetary Support
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London School of Hygiene and Tropical Medicine and WHO
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