OPtimal Timing of Thromboprophylaxis in Traumatic IntraCranial Haemorrhage - Pilot Study

• Register: ClinicalTrials.gov
• Last refreshed on: 20 April 2015
• Main ID: NCT02260908
• Date of registration: 06/10/2014
• Prospective Registration: No
• Primary sponsor: McMaster University
• Public title: OPtimal Timing of Thromboprophylaxis in Traumatic IntraCranial Haemorrhage - Pilot Study OPTTICH
• Scientific title: OPTTICH Pilot Study - OPtimal Timing of Thromboprophylaxis in Traumatic IntraCranial Haemorrhage
• Date of first enrolment: October 2014
• Target sample size: 300
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT02260908
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
• Phase: N/A

Countries of recruitment

Canada

Contacts

• Name: Niv Sne, MD FRCSC

• Name: Niv Sne, MD FRCSC

• Name: Niv Sne, MD FRCSC
• Affiliation: Hamilton Health Sciences/McMaster University

Key inclusion & exclusion 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



Age minimum: 16 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Traumatic Intracranial Haemorrhage

Intervention(s)

Drug: Enoxaparin

Other: Placebo

Primary Outcome(s)

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.]

Secondary Outcome(s)

Non-intracranial bleeding [Time Frame: Maximum of 60 days or until hospital discharge.]

Pulmonary Embolism (PE) [Time Frame: Maximum of 60 days or until hospital discharge.]

Intracranial haemorrhage progression (IHP) [Time Frame: Maximum of 60 days or until hospital discharge.]

Secondary ID(s)

OPT1-22-06-10

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Canadian Institutes of Health Research (CIHR)