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Background: Our group has created an algorithm for venous thromboembolism prophylaxis after traumatic brain injury (TBI), which stratifies patients into low, moderate, and high risk for spontaneous injury progression and tailors a prophylaxis regimen to each arm. We present the results of the Delayed Versus Early Enoxaparin Prophylaxis I study, a double-blind, placebo-controlled, randomized pilot trial on the low-risk arm., Methods: In this two-institution study, patients presenting within 6 hours of injury with prespecified small TBI patterns and stable scans at 24 hours after injury were randomized to receive enoxaparin 30 mg bid or placebo from 24 to 96 hours after injury in a double-blind fashion. An additional computed tomography scan was obtained on all subjects 24 hours after starting treatment (and therefore 48 hours after injury). The primary end point was the radiographic worsening of TBI; secondary end points were venous thromboembolism occurrence and extracranial hemorrhagic complications., Results: A total of 683 consecutive patients with TBI were screened during the 28 center months. The most common exclusions were for injuries larger than the prespecified criteria (n = 199) and preinjury anticoagulant use (n = 138). Sixty-two patients were randomized to enoxaparin (n = 34) or placebo (n = 28). Subclinical, radiographic TBI progression rates on the scans performed 48 hours after injury and 24 hours after start of treatment were 5.9% (95% confidence interval [CI], 0.7-19.7%) for enoxaparin and 3.6% (95% CI, 0.1-18.3%) for placebo, a treatment effect difference of 2.3% (95% CI, -14.42-16.5%). No clinical TBI progressions occurred. One deep vein thrombosis occurred in the placebo arm., Conclusion: TBI progression rates after starting enoxaparin in small, stable injuries 24 hours after injury are similar to those of placebo and are subclinical. The next Delayed Versus Early Enoxaparin Prophylaxis studies will assess efficacy of this practice in a powered study on the low-risk arm and a pilot trial of safety of a 72-hour time point in the moderate-risk arm., Level of Evidence: Therapeutic study, level II.

Background: Venous thromboembolism (VTE) is a significant risk in trauma patients. Although low-molecular weight heparin (LMWH) is effective in VTE prophylaxis, its use for patients with traumatic intracranial hemorrhage remains controversial. The purpose of this study was to evaluate the safety of LMWH for VTE prophylaxis in blunt intracranial injury., Methods: We conducted a retrospective multicenter study of LMWH chemoprophylaxis on patients with intracranial hemorrhage caused by blunt trauma. Patients with brain Abbreviated Injury Scale score of 3 or higher, age 18 years or older, and at least one repeated head computed tomographic scan were included. Patients with previous VTE; on preinjury anticoagulation; hospitalized for less than 48 hours; on heparin for VTE prophylaxis; or required emergent thoracic, abdominal, or vascular surgery at admission were excluded. Patients were divided into two groups: those who received LMWH and those who did not. The primary outcome was progression of intracranial hemorrhage on repeated head computed tomographic scan., Results: The study included 1,215 patients, of which 220 patients (18.1%) received LMWH and 995 (81.9%) did not. Hemorrhage progression occurred in 239 of 995 control subjects and 93 of 220 LMWH patients (24% vs. 42%, p < 0.001). Hemorrhage progression occurred in 32 patients after initiating LMWH (14.5%). Nine of these patients (4.1%) required neurosurgical intervention for hemorrhage progression., Conclusion: Patients receiving LMWH were at higher risk for hemorrhage progression. We were unable to demonstrate safety of LMWH for VTE prophylaxis in patients with brain injury. The risk of using LMWH may exceed its benefit., Level of Evidence: Therapeutic study, level IV., (Copyright © 2012 by Lippincott Williams & Wilkins.)

Background: We have created a theoretical algorithm for venous thromboembolism prophylaxis after traumatic brain injury (TBI) known as the Parkland Protocol, which stratifies patients into low-, medium-, and high-risk categories for spontaneous progression of hemorrhage. This prospective study characterizes the incidence and timing of radiographic progression of the TBI patterns in these categories., Methods: Inclusion criterion was presentation with intracranial blood between February 2010 and March 2011; exclusion was receipt of only one computed tomographic scan of the head during the inpatient stay or preinjury warfarin. At admission, all patients were preliminarily categorized per the Parkland Protocol as follows: low risk (LR), patients meeting the modified Berne-Norwood criteria; moderate risk (MR), injuries larger than the modified Berne-Norwood criteria without requiring a neurosurgical procedure; high risk (HR), any patient with a craniotomy/monitor., Results: A total of 245 patients with intracranial hemorrhage were enrolled during the 13-month study period. Of patients preliminarily classified as LR at admission (n = 136), progression was seen in 25.0%. Spontaneous worsening was seen in 7.4% of LR patients at 24 hours after injury, and no LR patients progressed at 72 hours after injury. In patients initially classified as MR at admission (n = 42), progression was seen in 42.9%, with 91.5% of patients demonstrating stable computed tomographic head scans at 72 hours after injury. In patients initially classified as HR (n = 67), 64.2% demonstrated spontaneous progression of their TBI patterns, with 10.5% continuing to progress at 72 hours after injury. Most repeat scans were performed as routinely scheduled studies (81-91%)., Conclusion: Increases in the incidence of spontaneous worsening were seen as severities of injury progressed from the Parkland Protocol's LR to MR to HR arms. The time frames for these spontaneous worsenings seem to be such that the protocol's theoretical recommendations for venous thromboembolism prophylaxis are worth pursuing as future points of investigation.