Timing of VTE Prophylaxis in TBI

NCT03081169 | Withdrawn Phase 4 DMC FDA Drug

• 1 other identifier: 209199
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

TBI (Traumatic Brain Injury); VTE (Venous Thromboembolism)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Bleeding complications

  Outcomes will be assessed until hospital discharge. Data will be presented at study completion with the expectation of approximately 2 years.

Study Arms (2)

Early (24 hours)

ACTIVE COMPARATOR

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; Drug: Heparin

Late (72 hours)

ACTIVE COMPARATOR

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; Drug: Heparin

Interventions

Enoxaparin Sodium 150 MG/ML Prefilled Syringe DRUG

The same drugs and dosages will be used in both groups, with only the timing being different

Also known as: Lovenox

Early (24 hours); Late (72 hours)

Heparin DRUG

The same drugs and dosages will be used in both groups, with only the timing being different

Early (24 hours); Late (72 hours)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Traumatic brain injury
• Intracranial hemorrhage on CT scan

You may not qualify if:

• 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

Sponsors & Collaborators

• Loyola University: lead

Study Sites (1)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Venous Thromboembolism

Interventions

enoxaparin sodium; Enoxaparin; Heparin

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Study Record Dates

• First Submitted: January 25, 2017
• First Posted: March 16, 2017
• Study Start: April 3, 2017
• Primary Completion: August 12, 2019
• Study Completion: August 12, 2019
• Last Updated: August 16, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)