Timing of VTE Prophylaxis in TBI

Timing of Venous Thromboembolism Prophylaxis in Traumatic Brain Injury

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.

Study Overview

• Status: Withdrawn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

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 Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Maywood, Illinois, United States, 60153
      • Loyola University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Early (24 hours); 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; The same drugs and dosages will be used in both groups, with only the timing being different; Other Names: Lovenox; Drug: Heparin; The same drugs and dosages will be used in both groups, with only the timing being different
Active Comparator: Late (72 hours); 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; The same drugs and dosages will be used in both groups, with only the timing being different; Other Names: Lovenox; Drug: Heparin; The same drugs and dosages will be used in both groups, with only the timing being different

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Loyola University

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2017
• Primary Completion (Actual): August 12, 2019
• Study Completion (Actual): August 12, 2019

Study Registration Dates

• First Submitted: January 25, 2017
• First Submitted That Met QC Criteria: March 9, 2017
• First Posted (Actual): March 16, 2017

Study Record Updates

• Last Update Posted (Actual): August 16, 2019
• Last Update Submitted That Met QC Criteria: August 14, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Embolism and Thrombosis; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic; Thromboembolism; Venous Thromboembolism; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin; Enoxaparin; Enoxaparin sodium
• Other Study ID Numbers: 209199

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No