Timing of VTE Prophylaxis in TBI

Study Overview
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Brief Summary
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This study compares the efficacy and complication rates of early (24 hours) versus late (72 hours) VTE prophylaxis administration to TBI patients. Patients in both treatment groups will be monitored for development of VTE as well as complications from bleeding after commencement of VTE prophylaxis.

Detailed Description
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This a randomized prospective study that compares the efficacy and complication rates of early (24 hours) versus late (72 hours) VTE prophylaxis administration to TBI patients. Patients who are identified as having an intracranial injury will be randomized to early versus late VTE prophylaxis using a 1:1 random numbers allocation. Patients in both treatment groups will be monitored for development of VTE, primarily with scheduled duplex ultrasound studies of the lower extremities. Any clinical suspicion of VTE will also be investigated with duplex ultrasound and/or CT angiogram of the chest. Patients will be monitored for development of complications from bleeding post commencement of VTE prophylaxis. Intracranial bleeding complications will be monitored by physical examination and CT scanning of the head when indicated. Patients who undergo craniotomy or craniectomy will have VTE prophylaxis started 72 hours post-surgery and will undergo CT scan of the head (to assure bleeding stabilization) prior to administration of VTE prophylaxis.

Official Title
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Timing of Venous Thromboembolism Prophylaxis in Traumatic Brain Injury

Conditions
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TBI (Traumatic Brain Injury), VTE (Venous Thromboembolism)

Intervention / Treatment
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* Drug: Enoxaparin Sodium 150 MG/ML Prefilled Syringe
* Drug: Heparin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Traumatic brain injury Intracranial hemorrhage on CT scan Exclusion Criteria: Under the age of 18 Pregnant Die within 24 hours of admission Hospital stay less than 5 days Contraindications to enoxaparin or heparin Coagulopathy at 24 hours post-injury defined as INR>1.6 aPTT>2x normal, or platelet counts<50k Known history of VTE

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Early (24 hours)<br>Patients will receive VTE prophylaxis (heparin 5000 U q 8 hrs or enoxaparin 30 mg q 12 hrs) 24 hours after injury if CT head is stable. | Drug: Enoxaparin Sodium 150 MG/ML Prefilled Syringe<br>* The same drugs and dosages will be used in both groups, with only the timing being different<br>* Other names: Lovenox;Drug: Heparin<br>* The same drugs and dosages will be used in both groups, with only the timing being different<br>|
| Active Comparator: Late (72 hours)<br>Patients will receive VTE prophylaxis (heparin 5000 U q 8 hrs or enoxaparin 30 mg q 12 hrs) 72 hours after injury if CT head is stable. | Drug: Enoxaparin Sodium 150 MG/ML Prefilled Syringe<br>* The same drugs and dosages will be used in both groups, with only the timing being different<br>* Other names: Lovenox;Drug: Heparin<br>* The same drugs and dosages will be used in both groups, with only the timing being different<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VTE | Rate of venous thromboembolism (DVT or PE) | Outcomes will be assessed until hospital discharge. Data will be presented at study completion with the expectation of approximately 2 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding complications | Rate of expanding intracranial hemorrhage | Outcomes will be assessed until hospital discharge. Data will be presented at study completion with the expectation of approximately 2 years. |