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

Journal of Trauma and Acute Care Surgery

Volumn 73, Issue 6, 2012, Pages 1434-1441

  Phelan, Herb A ^a   Wolf, Steven E ^a   Norwood, Scott H ^b   Aldy, Kim ^a   Brakenridge, Scott C ^c   Eastman, Alexander L ^a   Madden, Christopher J ^a   Nakonezny, Paul A ^d   Yang, Lisa ^a   Chason, David P ^a   Arbique, Gary M ^a   Berne, John ^e   Minei, Joseph P ^a  

^a UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER   (United States)

^b UNIVERSITY OF SOUTH FLORIDA   (United States)

^c UNIVERSITY OF WASHINGTON   (United States)

^d UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER   (United States)

^e EAST TEXAS MEDICAL CENTER   (United States)

Author keywords

Brain injury; enoxaparin; prophylaxis; randomized trial; venous thromboembolism

Indexed keywords

ENOXAPARIN; PLACEBO;

ADULT; ANTICOAGULANT THERAPY; ARTICLE; BLEEDING; BRAIN HEMORRHAGE; BRAIN TOMOGRAPHY; COMPUTER ASSISTED TOMOGRAPHY; CONTROLLED STUDY; DEEP VEIN THROMBOSIS; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG WITHDRAWAL; FEMALE; HIGH RISK PATIENT; HUMAN; INJURY SEVERITY; LOW RISK POPULATION; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NEUROLOGIC EXAMINATION; OUTCOME ASSESSMENT; PATIENT COMPLIANCE; PILOT STUDY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; THROMBOSIS PREVENTION; TRAUMATIC BRAIN INJURY; VENOUS THROMBOEMBOLISM;

ADULT; ANTICOAGULANTS; BRAIN INJURIES; DOUBLE-BLIND METHOD; ENOXAPARIN; FEMALE; HUMANS; INTRACRANIAL HEMORRHAGES; MALE; NEUROIMAGING; PILOT PROJECTS; TOMOGRAPHY, X-RAY COMPUTED; VENOUS THROMBOEMBOLISM;

EID: 84871225205     PISSN: 21630755     EISSN: 21630763     Source Type: Journal    
DOI: 10.1097/TA.0b013e31825ac49e     Document Type: Article

References (25)

1. Levy AS, Salottolo R, Bar-Or R, Offner P, Mains C, Sullivan M, and Bar-Or D. Pharmacologic thromboprophlaxis is a risk factor for hemorrhage progression in a subset of patients with traumatic brain injury. J Trauma. 2010;68:886-894.
2. Koehler DM, Shipman J, Davidson MA, et al. Is early venous thromboembolism prophylaxis safe in trauma patients with intracranial hemorrhage? J Trauma. 2011;70:324-329.
3. Minshall CT, Eriksson EA, Leon SM, et al. Safety and efficacy of heparin or enoxaparin prophylaxis in blunt trauma patients with a head abbreviated injury severity score 92. J Trauma. 2011;71:396-400.
4. Scudday T, Brasel K, Webb T, et al. Safety and efficacy of prophylactic anticoagulation in patients with traumatic brain injury. JACS. 2011;213: 148-154.
5. Reiff DA, Haricharan RN, Bullington NM, et al. Traumatic brain injury is associated with the development of deep vein thrombosis independent of pharmacologic prophylaxis. J Trauma. 2009;66:1436-1440.
6. Kim J, Gearhart MM, Zurick A, et al. Preliminary report on the safety of heparin for deep venous thrombosis prophylaxis after severe head injury. J Trauma. 2002;53:38-43.
7. Gearhart MM, Luchette FA, Proctor MC, et al. The risk assessment profile score identifies trauma patients at risk for deep vein thrombosis. Surgery. 2000;128:631-640.
8. Kurtoglu M, Yanar H, Bilsel Y, et al. Venous thromboembolism prophylaxis after head and spinal trauma: intermittent pneumatic compression devices versus low molecular weight heparin. World J Surg. 2004;28: 807-811.
9. Cothren CC, Smith WR, Moore EE, et al. Utility of once-daily dose of low molecular weight heparin to prevent VTE in multisystem trauma patients. World J Surg. 2007;31:98-104.
10. Depew AJ, Hu CK, Nguyen AC, et al. Thromboembolic prophylaxis in blunt traumatic intracranial hemorrhage: a retrospective review. Am Surg. 2008;74:906-911.
11. Dudley RR, Aziz I, Bonnici A, et al. Early venous thromboembolic event prophylaxis in traumatic brain injury with low-molecular-weight heparin: risks and benefits. J Neurotrauma. 2010;27:2165-2172.
12. Phelan HA, Eastman AL, Madden CJ, et al. TBI risk stratification at presentation: a prospective study of the incidence and timing of radiographic worsening in the Parkland Protocol. J Trauma. 2012;73: S122-127.
13. Norwood SH, McAuley CE, Berne JD, et al. A potentially expanded role for enoxaparin in preventing venous thromboembolism in high risk blunt trauma patients. JACS. 2001;192:161-167.
14. Norwood SH, McAuley CE, Berne JD, et al. Prospective evaluation of the safety of enoxaparin prophylaxis for venous thromboembolism in patients with intracranial hemorrhagic injuries. Arch Surg. 2002;137: 696-702.
15. Norwood SH, Berne JD, Rowe SA, et al. Early venous thromboembolism prophylaxis with enoxaparin in patients with blunt traumatic brain injury. J Trauma. 2008;65:1021-1027.
16. US Department of Health and Human Services. V: data analysis considerations. In: ICH topic E9-Guidance for Industry: Statistical Principles for Clinical Trials. 1998.
17. Chow SC, Liu JP. Design and Analysis of Clinical Trials: Concepts and Methodologies 2nd ed. Hoboken, NJ: Wiley Interscience; 2004.
18. Fleiss JL. Statistical Methods for Rates and Proportions. 3rd ed. New York: John Wiley & Sons, Inc.; 2003.
19. Fleiss JL, Nee JCM, Landis JR. Large sample variance of kappa in the case of different sets of raters. Psychol Bull. 1979;86:974-977.
20. Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977;33:159-174.
21. Cohen J. A coefficient of agreement for nominal scales. Educa Psychol Meas. 1960;20:37-46.
22. Fleiss JL. Measuring nominal scale agreement among many raters. Psychol Bull. 1971;76:378-382.
23. Gwet KL. Kappa statistic is not satisfactory for assessing the extent of agreement between raters. Stat Methods Inter-Rater Reliability Assess. 2002;1:1-5.
24. Gwet KL. Computing inter-rater reliability and its variance in the presence of high agreement. Br J Math Stat Psychol. 2008;61:29-48.
25. Geerts WH, Bergqvist D, Pineo GF, et al. Prevention of venous thromboembolism: American College of Chest Physicians Evidence- Based Clinical Practice Guidelines (8th Edition). Chest. 2008;133: 381SY453S.