Prophylaxis for venous thromboembolism during rehabilitation for traumatic brain injury: a multicenter observational study.

BACKGROUND: Deep venous thrombosis (DVT) is a major cause of mortality and morbidity after traumatic brain injury (TBI). There is no consensus regarding appropriate screening, prophylaxis, or treatment during acute rehabilitation. METHODS: This prospective observational study evaluated prophylactic anticoagulation during rehabilitation in patients with TBI aged 16 years or older admitted to 12 TBI Model Systems rehabilitation centers (July 2004-December 2007). After propensity score stratification within center, the odds ratio associated with incidence of symptomatic DVT or pulmonary embolism (PE) for patients who did and did not receive prophylactic anticoagulation was estimated using conditional logistic regression in patients who were not screened for DVT on rehabilitation admission or who screened negative; the analysis was repeated in these two subgroups. RESULTS: Patients with identified DVTs at rehabilitation admission (n = 266) were excluded, leaving 1,897 patients: 1,002 screened negative, 895 unscreened; 932 received prophylactic anticoagulation, and 965 did not. Symptomatic DVT/PE was detected in 32 patients (15 of 932 [1.6%] with prophylaxis, 17 of 965 [1.8%] without). After propensity score adjustment, the odds ratio (95% confidence interval) for symptomatic DVT/PE with prophylaxis versus no prophylaxis was 0.80 (0.33-1.94) in the full analytic population and 0.46 (0.12-1.84) in the screened-negative subgroup. The only probable venous thromboembolism-related death occurred in the prophylactic anticoagulation group. Fewer new/expanded intracranial hemorrhages occurred among patients who received prophylactic anticoagulation. CONCLUSIONS: Prophylactic anticoagulation during rehabilitation seemed safe for TBI patients whose physicians deemed it appropriate, but did not conclusively reduce venous thromboembolism. Given the number of DVTs present before rehabilitation, screening and prophylaxis during acute care may be more important.

A randomized controlled trial of sertraline for the treatment of depression in persons with traumatic brain injury.

OBJECTIVE: To examine the efficacy of sertraline in the treatment of depression after traumatic brain injury (TBI). DESIGN: Double-blind, randomized controlled trial. SETTING: Research center at a major urban medical center. PARTICIPANTS: Subjects were a referred and volunteer sample of 52 participants with TBI, a diagnosis of major depression disorder (MDD), and a score on the Hamilton Rating Scale for Depression (HAM-D) of 18 or greater. The majority of the sample was male (58%), had less than 14 years of education (73%), had incomes below $20,000 (82%), and were from minority backgrounds (75%). Approximately one third of the sample had mild brain injuries, and two thirds had moderate to severe brain injuries. The mean age was 47+/-11, and the mean time since injury was 17+/-14 years. One participant withdrew from the study because of side effects. INTERVENTION: Daily oral sertraline in doses starting at 25mg and increasing to therapeutic levels (up to 200mg) or placebo for 10 weeks. MAIN OUTCOME MEASURES: The HAM-D, the Beck Anxiety Inventory, and the Life-3 quality of life (QOL). RESULTS: No statistically significant differences were found at baseline between drug and placebo groups on baseline measures of depression (24.8+/-7.3 vs 27.7+/-7.0), anxiety (16.4+/-12.3 vs 24.0+/-14.9), or QOL (2.96+/-1.0 vs 2.9+/-0.9). The income level of those receiving placebo was significantly lower than those participants receiving medication. Analyses of covariance revealed significant changes from preintervention to posttreatment for all 3 outcome measures (P<.001) but no group effects. Random-effects modeling did not find any significant difference in patterns of scores of the outcome measures between the placebo and medication groups. CONCLUSIONS: Both groups showed improvements in mood, anxiety, and QOL, with 59% of the experimental group and 32% of the placebo group responding to the treatment, defined as a reduction of a person's HAM-D score by 50%.

Botulinum toxin dilution and endplate targeting in spasticity: a double-blind controlled study.

OBJECTIVE: To determine the effects of botulinum neurotoxin type A (BTX-A) dilution and endplate-targeting in spastic elbow flexors. DESIGN: Double blind randomized controlled trial; 4-month follow-up after a 160-unit injection of BTX-A into spastic biceps brachii (4 sites). Randomization into: group 1: 100 mouse units (MU)/mL dilution, 0.4cc/site, 4-quadrant injection; group 2: 100MU/mL dilution, 0.4cc/site, 4 sites along endplate band; group 3: 20MU/mL dilution, 2cc/site, 4-quadrant injection (n=7 per group). SETTING: Institutional tertiary care ambulatory clinic. PARTICIPANTS: Referred sample of 21 adults with spastic hemiparesis. No participant withdrew due to adverse effects. INTERVENTION: A 160-unit injection of BTX-A of different dilutions and locations into biceps brachii. MAIN OUTCOME MEASURES: Primary: agonist and antagonist (cocontraction) mean rectified voltage (MRV) of elbow flexors/extensors during maximal isometric flexion/extension; secondary: maximal voluntary power of elbow flexion/extension; spasticity angle and grade in elbow flexors/extensors (Tardieu Scale); active range of elbow extension/flexion. RESULTS: BTX-A injection overall reduced agonist flexor MRV (-47.5%, P<0.0001), antagonist flexor MRV (-12%, P=.037), antagonist extensor MRV (-19%, P<.01), flexion maximal voluntary power (-33%, P<.001), elbow flexor spasticity angle (-30%, P<.001) and grade (-17%, P=.03), and increased extension maximal voluntary power (24%, P=.037) and active range of elbow extension (5.5%, 8 degrees , P=.002). Agonist and antagonist flexor MRV reductions in group 3 (-81% and -31%) were greater than in groups 1 and 2, whereas increase in active range of elbow extension was greater in group 2 (10%) than in groups 1 and 3 (P<.05, analysis of covariance [ANCOVA]). Elbow flexor spasticity was significantly reduced in groups 2 and 3 only (P<.05, ANCOVA). CONCLUSIONS: In spastic biceps, high-volume or endplate-targeted BTX-A injections achieve greater neuromuscular blockade, cocontraction and spasticity reduction, and active range of elbow extension improvement, than low volume, nontargeted injections.

Fatigue after traumatic brain injury and its impact on participation and quality of life.

OBJECTIVES: To examine the relationships between post-TBI fatigue (PTBIF) and comorbid conditions, participation in activities, quality of life, and demographic and injury variables. PARTICIPANTS: 223 community-dwelling individuals with mild to severe TBI and 85 noninjured controls. MEASURES: Global Fatigue Index (GFI), Beck Depression Inventory (BDI-II), McGill Pain Questionnaire (MPQ), Pittsburgh Sleep Quality Inventory (PSQI), Participation Objective Participation Subjective (POPS), SF-36, Life-3. METHOD: Data were collected through interviews and administration of self-report measures as part of a study of PTBIF. RESULTS: Fatigue was more severe and prevalent in individuals with TBI, and more severe among women. It was not correlated with other demographic and injury variables. Once overlap in measurement instruments' content was removed, depression, pain, and sleep problems accounted for approximately 23% of the variance in fatigue in those with TBI compared to 58% of the variance in the control group. PTBIF was correlated with health-related quality of life and overall quality of life, but was not generally related to participation in major life activities. CONCLUSIONS: PTBIF has significant impact on well-being and quality of life and cannot be accounted for by comorbid conditions alone, suggesting that it is related to brain injury itself. It appears to be unrelated to demographic and injury variables other than gender. PTBIF does not limit the quantity and frequency of participation. Future research should focus on the relationship between fatigue and the quality of participation.