OPtimal Timing of Thromboprophylaxis in Traumatic IntraCranial Haemorrhage - Pilot Study
Status:
Unknown status
Trial end date:
2016-09-01
Target enrollment:
Participant gender:
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 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.