OPtimal Timing of Thromboprophylaxis in Traumatic IntraCranial Haemorrhage - Pilot Study

NCT ID: NCT02260908

Last Updated: 2015-04-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2016-09-30

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Enoxaparin

Intervention Type: DRUG

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

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

Enoxaparin

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

Intervention Type: DRUG

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.

Intervention Type: OTHER

Other Intervention Names

Lovenox

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Niv Sne

Dr. Niv Sne, Director of Trauma Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Niv Sne, MD FRCSC

Role: PRINCIPAL_INVESTIGATOR

Hamilton Health Sciences/McMaster University

Locations

Hamilton Health Sciences- General site

Hamilton, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Niv Sne, MD FRCSC

Role: CONTACT

nivsne@yahoo.ca

905-527-4322 ext. 44665

Timothy Rice, MD

Role: CONTACT

timothy.rice@medportal.ca

905-527-4322 ext. 44665

Facility Contacts

Niv Sne, MD FRCSC

Role: primary

nivsne@yahoo.ca

905-527-4322 ext. 44665

Other Identifiers

OPT1-22-06-10

Identifier Type: -

Identifier Source: org_study_id