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Anticoagulant

Early initiation of thromboprophylaxis for Brain Bleed (OPTTICH Trial)

N/A
Waitlist Available
Led By Niv Sne, MD FRCSC
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Multi-system trauma patients referred to the trauma service with a non-progressing tICH documented on 24-hour repeat head CT scan
Timeline
Screening 3 weeks
Treatment Varies
Follow Up maximum of 60 days or until hospital discharge.
Awards & highlights

OPTTICH Trial 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.

Eligible Conditions
  • Brain Bleed

OPTTICH Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

OPTTICH Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~maximum of 60 days or until hospital discharge.
This trial's timeline: 3 weeks for screening, Varies for treatment, and maximum of 60 days or until hospital discharge. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proximal lower limb deep vein thrombosis (DVT) diagnosed by bilateral lower extremity compression ultrasound (US).
Secondary outcome measures
Intracranial haemorrhage progression (IHP)
Non-intracranial bleeding
Pulmonary Embolism (PE)

OPTTICH Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Early initiation of thromboprophylaxisActive Control1 Intervention
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 II: Late initiation of thromboprophylaxisPlacebo Group1 Intervention
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.

Find a Location

Who is running the clinical trial?

Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,345 Previous Clinical Trials
26,453,214 Total Patients Enrolled
McMaster UniversityLead Sponsor
885 Previous Clinical Trials
2,598,043 Total Patients Enrolled
Niv Sne, MD FRCSCPrincipal InvestigatorHamilton Health Sciences/McMaster University
2 Previous Clinical Trials
612 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~28 spots leftby May 2025