Home » Trials » SLCTR/2007/008
Clinical Randomization of an Antifibrinolytic agent in Significant Haemorrhage
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SLCTR Registration Number
SLCTR/2007/008
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
Clinical Randomization of an Antifibrinolytic agent in Significant Haemorrhage
Public Title of Trial
Clinical randomization of an Antifibrinolytic agent in Significant Haemorrhage
Disease or Health Condition(s) Studied
Haemorrhage following trauma
Scientific Acronym
CRASH 2
Public Acronym
CRASH 2
Brief title
Clinical randomization of an Antifibrinolytic agent in Significant Haemorrhage
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
Protocol number ISRCTN86750102, EudraCT 2004-002955-14
What is the research question being addressed?
Effect of the early administration of the antifibrinolytic agent tranexamic acid on death and transfusion requirement?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded
Control
Placebo
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Available
Intervention(s) planned
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
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
Primary outcome(s)
|
1.
Death in hospital within 4 weeks of injury |
[ Within 4 weeks of injury ] |
Secondary outcome(s)
|
1.
Receipt of a blood products transfusion, the number of units of blood products transfused, surgical intervention & the occurrence of thrombo- embolic episodes |
[] |
Target number/sample size
20,000 (worldwide)
Countries of recruitment
Albania, Argentina, Australia, Belgium, Cameroon, Canada, Colombia, Cuba, Czech Republic, Ecuador, Egypt, Georgia, India, Indonesia, Iran, Islamic Republic of, Iraq, Italy, Japan, Malaysia, Mexico, Nigeria, Peru, Saudi Arabia
Anticipated start date
2007-09-01
Anticipated end date
2010-12-31
Date of first enrollment
2007-09-01
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
London School of Hygiene & Tropical Medicine and WHO
Regulatory approvals
Status
Approved
Date of Approval
2007-03-07
Approval number
AA/ETH/2006
Details of Ethics Review Committee
| Name: | Ethics Review Committee of the National Hospital of Sri Lanka |
| Institutional Address: | National Hospital of Sri Lanka, Colombo Sri Lanka |
| Telephone: | Not Available |
| Email: | Not Available |
Contact person for Scientific Queries/Principal Investigator
Dr. R.N. Ellawala
Consultant Surgeon
Accident Service , National Hospital of Sri Lanka, Colombo
+ 94(0)777316933
ranjithellawala@yahoo.com
Contact Person for Public Queries
Ms Haleema Shakur
Trials Manager
LSHTM, Keppel Street, London WC1E 7HT, UK
+44(0)20 7958 8113
+44(0)20 7299 4663
Haleema.Shakur@Lshtm.ac.uk
Primary study sponsor/organization
London School of Hygiene and Tropical Medicine
Keppel street, London WC1 E 7HT, UK
+44+20 7299 4684
+44+20 7299 4663
crash@Lshtm.ac.uk
WWW.CRASH 2.LSHTMK.AC.UK
Secondary study sponsor (If any)
Penny Ireland (Research Contracts Officer)
London School of Hygiene & Tropical Medicine, Keppel Street, London WC1E 7HT, UK
+44(0)20 7636 8636
www.Lshtm.ac.uk, www.crash2.lshtm.ac.uk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
