OPtimal Timing of Thromboprophylaxis in Traumatic IntraCranial Haemorrhage - Pilot Study
OPtimal Timing of Thromboprophylaxis in Traumatic IntraCranial Haemorrhage - Pilot Study
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 to the lungs, resulting in death. Blood thinners can be given to patients to
 prevent blood clots from developing but this can leave patients at risk for additional
 bleeding in the brain, causing further damage or death. The earlier blood thinners are
 started, the more effective they are at preventing blood clots. In addition, some patients
 with severe head injury who have bled into their brains will develop further bleeding even if
 they do not receive blood thinners. Even though a growing body of research has shown that the
 majority of bleeding in the brain stops within the first 24 hours after injury and that it is
 safe to start blood thinners as early as 24 hours after injury, doctors are still waiting
 longer than 4 days to start blood thinners in these patients over concerns of worsening
 bleeding. In Canada, almost half of the patients with severe head injury do not receive blood
 thinners until at least five days after injury. Delays in starting blood thinners appear to
 put patients at increased risk of developing blood clots, unnecessarily. This study will
 compare the benefits of starting low-molecular-weight heparin (LMWH), a type of blood
 thinner, early (36 to 48 hours after injury) versus the current practice (waiting until the
 6th day after being injured) in preventing blood clots in patients who have bled into their
 brains after severe head injury. The investigators believe that starting LMWH earlier will be
 more effective in preventing blood clots without worsening any bleeding when compared to
 waiting to start blood thinners. This study is called OPTTICH (OPtimal timing of
 Thromboprophylaxis in Traumatic IntraCranial Haemorrhage) and will be the largest Canadian
 investigator-initiated randomized control trial on blood clot prevention in trauma patients
 with severe head injury who have bled into their brains.
Inclusion Criteria:

 -  Multi-system trauma patients referred to the trauma service with a non-progressing
 tICH documented on 24-hour repeat head CT scan

 Exclusion Criteria:

 -  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