Recruiting

Thromboprophylaxis

Sponsor:

McMaster University

Code:

NCT02260908

Conditions

Traumatic Intracranial Haemorrhage

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

Interventions

Enoxaparin

Placebo

Study Details

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.

Conditions

Traumatic Intracranial Haemorrhage

Study ID

NCT02260908

Start date

Oct, 2014

Status verified date

Apr, 2015

Completion date

Sep, 2016

Anticipated

Primary completion date

Sep, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Early initiation of thromboprophylaxis

Early initiation of thromboprophylaxis with Enoxaparin between 36-48 hours post-injury until day 5, followed by standard of care (DVT prophylaxis with Enoxaparin) starting on post-injury day 6.

placebo comparator: Late initiation of thromboprophylaxis

Initiation of placebo (normal saline) 36-48 hours post-injury until day 5, followed by standard of care (DVT prophylaxis with Enoxaparin) starting on post-injury day 6.

Interventions

Enoxaparin

Enoxaparin 30 mg subcutaneously twice daily for six doses, starting 36-48 hours post-traumatic injury.

Placebo

0.9% normal saline in equal volume to active comparator given subcutaneously twice daily for six doses, starting 36-48 hours post-traumatic injury.

Primary outcome measure

  • Proximal lower limb deep vein thrombosis (DVT) diagnosed by bilateral lower extremity compression ultrasound (US). [ Time Frame: Maximum of 60 days or until hospital discharge. ]

Central Contacts and Locations

Central contacts

Niv Sne, MD FRCSC

905-527-4322nivsne@yahoo.ca

Timothy Rice, MD

905-527-4322timothy.rice@medportal.ca

Locations

Hamilton Health Sciences- General site

Recruiting

Hamilton, Ontario, Canada, L8L 2X2

Contacts

Niv Sne, MD FRCSC

905-527-4322nivsne@yahoo.ca

Principal Investigator:

Niv Sne, MD FRCSC

More Information

Sponsor

McMaster University

Last update posted

Apr 10, 2015

Last verified

Apr, 2015

Keywords

  • Trauma
  • Thromboprophylaxis
  • Intracranial haemorrhage
  • Deep vein thrombosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McMaster University on 2015-04-10.