Timing of VTE Prophylaxis in TBI

Phase 4

Withdrawn

• Conditions: TBI (Traumatic Brain Injury); VTE (Venous Thromboembolism)
• Interventions: Drug: Enoxaparin Sodium 150 MG/ML Prefilled Syringe; Drug: Heparin

• Registration Number: NCT03081169
• Lead Sponsor: Loyola University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2017-01-25
• Study First Submitted QC: 2017-03-09
• Study First Posted: 2017-03-16
• Study Start: 2017-04-03
• Status Verified: 2019-08
• Primary Completion: 2019-08-12
• Study Completion: 2019-08-12
• Last Update Submitted: 2019-08-14
• Last Update Posted: 2019-08-16

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early (24 hours)	Enoxaparin Sodium 150 MG/ML Prefilled Syringe	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.
Early (24 hours)	Heparin	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.
Late (72 hours)	Enoxaparin Sodium 150 MG/ML Prefilled Syringe	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.
Late (72 hours)	Heparin	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.

Primary Outcome Measures

Name	Time	Method
VTE	Outcomes will be assessed until hospital discharge. Data will be presented at study completion with the expectation of approximately 2 years.	Rate of venous thromboembolism (DVT or PE)

Secondary Outcome Measures

Name	Time	Method
Bleeding complications	Outcomes will be assessed until hospital discharge. Data will be presented at study completion with the expectation of approximately 2 years.	Rate of expanding intracranial hemorrhage

Trial Locations

Locations (1)

Loyola University Medical Center; 🇺🇸 Maywood, Illinois, United States