Timing of VTE Prophylaxis in TBI

TBI (Traumatic Brain Injury) Clinical Trial

Official title:

Timing of Venous Thromboembolism Prophylaxis in Traumatic Brain Injury

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03081169
• Other study ID #: 209199
• Status: Withdrawn
• Phase: Phase 4
• Start date: April 3, 2017
• Est. completion date: August 12, 2019

Study information

• Verified date: August 2019
• Source: Loyola University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 12, 2019
• Est. primary completion date: August 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• TBI (Traumatic Brain Injury)
• Thromboembolism
• Venous Thromboembolism
• VTE (Venous Thromboembolism)

Intervention

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

Locations

Country	Name	City	State
United States	Loyola University Medical Center	Maywood	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Loyola University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.