Timing of VTE Prophylaxis in TBI



Status:Suspended
Conditions:Cardiology, Cardiology, Neurology
Therapuetic Areas:Cardiology / Vascular Diseases, Neurology
Healthy:No
Age Range:18 - Any
Updated:8/4/2018
Start Date:April 3, 2017
End Date:February 15, 2020

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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.

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.

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
We found this trial at
1
site
2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
Principal Investigator: Michael Anstadt, MD
Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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mi
from
Maywood, IL
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