Clinical trial NCT02260908: OPtimal Timing of Thromboprophylaxis in Traumatic IntraCranial Haemorrhage - Pilot Study
Official title: OPTTICH Pilot Study - OPtimal Timing of Thromboprophylaxis in Traumatic IntraCranial Haemorrhage
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Traumatic Intracranial Haemorrhage
Keywords: Trauma
Thromboprophylaxis
Intracranial haemorrhage
Deep vein thrombosis
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2014-10-09
Enrollment: 300
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Proximal lower limb deep vein thrombosis (DVT) diagnosed by bilateral lower extremity compression ultrasound (US).
timeFrame: Maximum of 60 days or until hospital discharge.
Secondary outcomes:
measure: Non-intracranial bleeding
timeFrame: Maximum of 60 days or until hospital discharge.
measure: Pulmonary Embolism (PE)
timeFrame: Maximum of 60 days or until hospital discharge.
measure: Intracranial haemorrhage progression (IHP)
timeFrame: Maximum of 60 days or until hospital discharge.
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences- General site
state: Ontario
Study officials:
affiliation: Hamilton Health Sciences/McMaster University
name: Niv Sne, MD FRCSC
role: PRINCIPAL_INVESTIGATOR
References: