Home » Trials » SLCTR/2007/008


Clinical Randomization of an Antifibrinolytic agent in Significant Haemorrhage -

SLCTR Registration Number

SLCTR/2007/008


Date of Registration

12 Jun 2007

The date of last modification

Feb 21, 2013


Trial Status



Application Summary


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 of 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 Trail Number

None


Any other number(s) assigned to the trial and issuing authority

Protocol number ISRCTN86750102, EudraCT 2004-002955-14


Trial Details


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


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)

Death in hospital within 4 weeks of injury


Primary outcome(s) - Time of assessment(s)

Within 4 weeks of injury


Secondary outcome

Receipt of a blood products transfusion, the number of units of blood products transfused, surgical intervention & the occurrence of thrombo- embolic episodes


Secondary outcome(s) - Time of assessment(s)

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


Recruitment status

Complete


State of ethics review approval

Approved by the Ethics Review Committee of the National Hospital of Sri Lanka


Funding source

London School of Hygiene & Tropical Medicine and WHO



Contact & Sponsor Information


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