During the period of acute rehabilitation for traumatic brain injury (TBI), the development of deep vein thrombosis (DVT) is a significant complication that increases morbidity and mortality. Pulmonary embolism (PE) is one of the most ominous, and frequently life-threatening, complications that occur during TBI rehabilitation. TBI patients often sustain concomitant multiple trauma and have cumulative risk factors for DVT. Because these TBI patients are usually maintained at bed rest during their acute hospitalization, they are at increased risk for existing DVT to embolize when they enter the rehabilitation setting and resume mobility. Prior to initiating this study, a practice survey was distributed to the 16 rehabilitation centers of the TBI Model Systems (TBIMS). Information was collected on current practice patterns and the number of fatal pulmonary emboli that had been witnessed in each physician's years of treating TBI patients in the rehabilitation setting. This survey revealed substantial variability in practice patterns that supports the value of conducting a prospective observational study to determine the efficacy of DVT prevention and management methods during inpatient rehabilitation. This survey revealed an occurrence rate of 0.42 fatal pulmonary emboli per year of practice for each physician reporting. This confirms the importance of improving methods of prevention, detection, and treatment of DVT in the rehabilitation setting. The Health Module of the TBIMS will conduct a prospective observational study of screening and prophylaxis for DVT in 11 participating centers of the TBIMS. Data will be collected via a Case Report Form and submitted quarterly to the National Data Center of the TBIMS. The primary objective will be to determine whether the use of prophylactic anticoagulants in the rehabilitation setting results in a lower rate of symptomatic DVT. Secondary objectives will be to determine whether anticoagulants f!
or prophylaxis prevent the occurrence of symptomatic PE, increase the risk of intracranial hemorrhage, increase the occurrence of extracranial (systemic) hemorrhage, and decrease the morbidity of DVT. Currently, there are no guidelines or accepted "standard of care" for DVT prophylaxis, screening, and treatment in the acute rehabilitation setting for TBI patients. No Class I evidence and very little Class II evidence exists to guide rehabilitation physicians in developing protocols for prevention and management of DVT following TBI. Although devastating in its potentially life-threatening outcome, the incidence of symptomatic DVT and pulmonary embolism is low. Large numbers of patients will be required to power this study. The TBI Model Systems provides an ideal vehicle to answer the questions concerning effective screening, prophylaxis, and treatment methods for DVT in the rehabilitation setting. It is estimated that 2,000 subjects will be enrolled in the study over the 3.5 year duration of the study. This large, multicenter study may provide the evidence upon which guidelines for screening and prophylaxis of DVT during inpatient rehabilitation after TBI can be based.
Registry Project Number: 467
Lead Investigator: Carlile, M
Lead Center for Project: North Texas Traumatic Brain Injury Model System
Collaborating Investigators: Diaz-Arrastia, R, Mysiw, W
Collaborating Institutions: Carolinas Rehabilitation, JFK Johnson Rehabilitation Institute, Mayo Medical Center, Mount Sinai School of Medicine, Santa Clara Valley Medical Center, Methodist Rehabilitation Center, Ohio State University, University of Alabama, University of Pittsburgh
Expected Completion: 09/30/2007
Type: Modular Collaborative
Status of Project: Latest Information Shown
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