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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
The same drugs and dosages will be used in both groups, with only the timing being different
The same drugs and dosages will be used in both groups, with only the timing being different
Loyola University Medical Center
Maywood, Illinois, United States
VTE
Rate of venous thromboembolism (DVT or PE)
Time frame: Outcomes will be assessed until hospital discharge. Data will be presented at study completion with the expectation of approximately 2 years.
Bleeding complications
Rate of expanding intracranial hemorrhage
Time frame: Outcomes will be assessed until hospital discharge. Data will be presented at study completion with the expectation of approximately 2 years.
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