Status:
UNKNOWN
OPtimal Timing of Thromboprophylaxis in Traumatic IntraCranial Haemorrhage - Pilot Study
Lead Sponsor:
McMaster University
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Traumatic Intracranial Haemorrhage
Eligibility:
All Genders
16+ years
Phase:
NA
Brief Summary
Victims of trauma with severe head injury who have bled into their brains are at high risk of developing blood clots in their legs. These blood clots can break off and travel through the bloodstream t...
Eligibility Criteria
Inclusion
- Multi-system trauma patients referred to the trauma service with a non-progressing tICH documented on 24-hour repeat head CT scan
Exclusion
- Unexpected to survive or remain in hospital \>72 hours
- Known malignancy under active care at time of admission
- Known DVT, PE or other condition requiring anticoagulation at time of admission
- Coagulopathy (defined as international normalized ratio (INR) values \>1.5 times the upper limit of normal, or partial thromboplastin time (PTT) values \>1.5 times the upper limit of normal) at 24 hours after admission
- Platelet count \<75 x 10\^9/L at 24 hours after admission
- Bilateral lower limb amputation
- History of allergy to heparin or suspected or proven HIT
- Limitation of life support or palliative care
- Prior enrollment in this trial or currently in a confounding randomized trial
- Pregnancy
- Study drug (LMWH or placebo) not administered within 36-48 hours post-injury
- Grade V liver or splenic injuries that have not received definitive care (e.g. embolization, surgical intervention) within 36-48 hours after injury
- Persistent intracranial pressure \>20 mm Hg
- Spinal subdural haematoma or spinal epidural haematoma
- Intracranial haemorrhage progression on 24-hour repeat CT scan
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2016
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT02260908
Start Date
October 1 2014
End Date
September 1 2016
Last Update
April 10 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hamilton Health Sciences- General site
Hamilton, Ontario, Canada, L8L 2X2