A randomized, double-blinded, placebo-controlled pilot trial of anticoagulation in low-risk traumatic brain injury

Phelan, Herb A.; Wolf, Steven E.; Norwood, Scott H.; Aldy, Kim; Brakenridge, Scott C.; Eastman, Alexander L.; Madden, Christopher J.; Nakonezny, Paul A.; Yang, Lisa W; Chason, David P.; Arbique, Gary; Berne, John D.; Minei, Joseph P.

doi:10.1097/ta.0b013e31825ac49e

Cited by 108 publications

(89 citation statements)

References 19 publications

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“…8,46 Phelan et al conducted a pilot randomized trial with an analysis of non-inferiority to examine the effects of prophylactic enoxaparin on progression of ICH among low-risk TBI patients. More specifically, TBI patients presenting within 6 hours of injury with small injury patterns and stabilized CT scans at 24 hours were considered having low risk.…”

Section: Resultsmentioning

confidence: 99%

“…Phelan et al and Scudday et al showed that PTP did not increase the incidence of ICH progression among patients with stable hemorrhage patterns. 12,46 The study by Levy et al stressed the importance of ensuring stability of hemorrhage patterns before initiating PTP. 8 The study demonstrated that PTP was safe among patients with a stable CT at 24 hours of admission but it would expose patients with initial ICH progression to a 13-fold higher risk of worsening ICH.…”

Section: Discussionmentioning

confidence: 99%

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A Systematic Review of the Benefits and Risks of Anticoagulation Following Traumatic Brain Injury

Shen

Dutcher

Palmer

et al. 2015

Journal of Head Trauma Rehabilitation

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Objective The objective of the study was Tto synthesize the existing literature on benefits and risks of anticoagulant use after traumatic brain injury (TBI). Design: Systematic review A literature search was performed in Medline, IPA, Health Star and CINAHL on October 11, 2012 and updated on September 2, 2013, using terms related to TBI and anticoagulants. Main Measures Human studies evaluating the effects of post-TBI anticoagulation on venous thromboembolism (VTE), hemorrhage, mortality or coagulation parameters with original analyses were eligible for the review. Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guideline was followed throughout the conduct of the review. Results Thirty-nine eligible studies were identified from the literature, of which 23 studies with complete information on post-TBI anticoagulant use and patient outcomes were summarized in this review. Meta-analysis was unwarranted due to varying methodological design and quality of the studies. Twenty-one studies focused on the effects of pharmacological thromboprophylaxis (PTP) post-TBI on VTE and/or progression of intracranial hemorrhage (ICH) while two RCTs analyzed coagulation parameters as the result of anticoagulation. Conclusion PTP appears to be safe among TBI patients with stabilized hemorrhagic patterns. More evidence is needed regarding effectiveness of PTP in preventing VTE as well as preferred agent, dose and timing for PTP.

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Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

A Systematic Review of the Benefits and Risks of Anticoagulation Following Traumatic Brain Injury

Shen

Dutcher

Palmer

et al. 2015

Journal of Head Trauma Rehabilitation

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“…20 In DEEP I, subjects in the low-risk arm with stable injury patterns on repeat scan at 24 h after injury were randomized to receive enoxaparin 30 mg subcutaneously or placebo in a double-blind fashion from 24 to 96 h after injury. After enrolling 62 subjects, no clinical progressions of hemorrhage were noted in either group.…”

Section: Discussionmentioning

confidence: 99%

The Parkland Protocol's Modified Berne-Norwood Criteria Predict Two Tiers of Risk for Traumatic Brain Injury Progression

Pastorek

Cripps

Bernstein

et al. 2014

Journal of Neurotrauma

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As a basis for venous thromboembolism (VTE) prophylaxis after traumatic brain injury (TBI), we have previously published an algorithm known as the Parkland Protocol. Patients are classified by risk for spontaneous progression of hemorrhage with chemoprophylaxis regimens tailored to each tier. We sought to validate this schema. In our algorithm, patients with any of the following are classified ''low risk'' for spontaneous progression: subdural hemorrhage £ 8 mm thick; epidural hemorrhage £ 8 mm thick; contusions £ 20 mm in diameter; a single contusion per lobe; any amount of subarachnoid hemorrhage; or any amount of intraventricular hemorrhage. Patients with any injury exceeding these are ''moderate risk'' for progression, and any patient receiving a monitor or craniotomy is ''high risk.'' From February 2010 to November 2012, TBI patients were entered into a dedicated database tracking injury types and sizes, risk category at presentation, and progression on subsequent computed tomgraphies (CTs). The cohort (n = 414) was classified as low risk (n = 200), moderate risk (n = 75), or high risk (n = 139) after first CT. After repeat CT scan, radiographic progression was noted in 27% of low-risk, 53% of moderate-risk, and 58% of high-risk subjects. Omnibus analysis of variance test for differences in progression rates was highly significant ( p < 0.0001). Tukey's post-hoc test showed the low-risk progression rate to be significantly different than both the moderate-and high-risk arms; no difference was noted between the moderate-and high-risk arms themselves. These criteria are a valid tool for classifying TBI patients into two categories of risk for spontaneous progression. This supports tailored chemoprophylaxis regimens for each arm.

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“…A randomized, double-blinded, placebocontrolled pilot trial of anticoagulation in low-risk traumatic brain injury: The Delayed Versus Early Enoxaparin Prophylaxis I (DEEP I) study 6 Rationale Rationale Rationale Rationale Rationale The timing to initiate VTE chemoprophylaxis in TBI is controversial, given the risk of progression of ICH. Different institutions use different algorithms that are supported by weak evidence and often consider TBI as a binary clinical state -either with or without ICH.…”

Section: Study 3 Study 3 Study 3 Study 3 Studymentioning

confidence: 99%

Profilaxia de tromboembolismo venoso em pacientes com lesão cerebral traumática

Zakrison¹,

Pereira

Marttos³

et al. 2012

Rev. Col. Bras. Cir.

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Traumatismo crânio-encefálico (TCE), com hemorragia intracraniana associada (HIC) ocorre com frequência em trauma. Pacientes vítimas de trauma também estão em alto risco de desenvolver complicações venosas tromboembólicas (TEV). Heparina de Baixo Peso Molecular (HBPM) é utilizada em pacientes de trauma, como profilaxia para reduzir o risco de eventos de TEV. Ainda não está claro, no entanto, se a HBPM é segura para uso em pacientes com trauma com HIC por receio da progressão do hematoma. O Clube de Revista "Telemedicina Baseada em Evidências: Cirurgia do Trauma e Emergência (TBE-CiTE)" realizou uma apreciação crítica de três estudos recentes e mais relevantes no tocante ao momento de início da profilaxia, à segurança e ao uso de HBPM em pacientes com trauma e HIC. Especificamente, três estudos foram revisados: i) uma revisão crítica da literatura sobre o tema, ii) um estudo multicêntrico, estudo de coorte retrospectivo avaliando a segurança de HBPM em pacientes com trauma, e com HIC e iii) um estudo piloto randomizado, avaliando a viabilidade e as taxas de eventos de progressão de HIC, servindo como base para futuros ensaios clínicos randomizados (ECR) sobre o tema. Alguns resultados são conflitantes, com o maior nível de evidência sendo o ECR piloto demonstrando a segurança para o uso precoce de HBPM no TCE associado com HIC. Grande parte desta pesquisa, porém, foi gerada por um único centro e, consequentemente, carece de validade externa. Além disso, as recomendações clínicas não podem ser geradas com base em estudos-piloto. Diretrizes baseadas em evidências e recomendações não podem ser feitas, neste momento, até a realização de outros estudos sobre este assunto desafiador.

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A randomized, double-blinded, placebo-controlled pilot trial of anticoagulation in low-risk traumatic brain injury

Abstract: Therapeutic study, level II.

Cited by 108 publications

References 19 publications

A Systematic Review of the Benefits and Risks of Anticoagulation Following Traumatic Brain Injury

A Systematic Review of the Benefits and Risks of Anticoagulation Following Traumatic Brain Injury

The Parkland Protocol's Modified Berne-Norwood Criteria Predict Two Tiers of Risk for Traumatic Brain Injury Progression

Profilaxia de tromboembolismo venoso em pacientes com lesão cerebral traumática

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