Document Detail


A randomized, double-blinded, placebo-controlled pilot trial of anticoagulation in low-risk traumatic brain injury: The Delayed Versus Early Enoxaparin Prophylaxis I (DEEP I) study.
MedLine Citation:
PMID:  22914079     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
Herb A Phelan; Steven E Wolf; Scott H Norwood; Kim Aldy; Scott C Brakenridge; Alexander L Eastman; Christopher J Madden; Paul A Nakonezny; Lisa Yang; David P Chason; Gary M Arbique; John Berne; Joseph P Minei
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  The journal of trauma and acute care surgery     Volume:  73     ISSN:  2163-0763     ISO Abbreviation:  J Trauma Acute Care Surg     Publication Date:  2012 Dec 
Date Detail:
Created Date:  2012-11-28     Completed Date:  2013-08-22     Revised Date:  2013-09-25    
Medline Journal Info:
Nlm Unique ID:  101570622     Medline TA:  J Trauma Acute Care Surg     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1434-41     Citation Subset:  AIM; IM    
Affiliation:
Division of Burns/Trauma/Critical Care , Department of Surgery, Parkland Memorial Hospital, UT Southwestern Medical Center, Dallas, Texas, USA. herb.phelan@utsouthwestern.edu
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MeSH Terms
Descriptor/Qualifier:
Adult
Anticoagulants / administration & dosage,  therapeutic use*
Brain Injuries / drug therapy*,  radiography
Double-Blind Method
Enoxaparin / administration & dosage,  therapeutic use*
Female
Humans
Intracranial Hemorrhages / drug therapy
Male
Neuroimaging
Pilot Projects
Tomography, X-Ray Computed
Venous Thromboembolism / prevention & control
Chemical
Reg. No./Substance:
0/Anticoagulants; 0/Enoxaparin

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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