PMID- 26317819
OWN - NLM
STAT- MEDLINE
DCOM- 20160505
LR  - 20220317
IS  - 2163-0763 (Electronic)
IS  - 2163-0755 (Linking)
VI  - 79
IP  - 6
DP  - 2015 Dec
TI  - Heparin versus enoxaparin for prevention of venous thromboembolism after trauma: 
      A randomized noninferiority trial.
PG  - 961-8; discussion 968-9
LID - 10.1097/TA.0000000000000750 [doi]
AB  - BACKGROUND: Research comparing enoxaparin with unfractionated heparin (UFH) given 
      every 12 hours for venous thromboembolism (VTE) prophylaxis after trauma 
      overlooks original recommendations that UFH be given every 8 hours. We conducted 
      a prospective, randomized, noninferiority trial comparing UFH every 8 hours and 
      standard enoxaparin every 12 hours. We hypothesized that the incidence of VTE in 
      trauma patients receiving UFH every 8 hours would be no more than 10% higher than 
      that in patients receiving enoxaparin every 12 hours. METHODS: Trauma patients 
      who met criteria for VTE prophylaxis at a Level I trauma center were randomly 
      assigned to 5,000-U UFH every 8 hours or 30-mg enoxaparin every 12 hours between 
      November 2012 and September 2014. Surveillance duplex ultrasound was performed 
      twice weekly on intensive care unit patients and weekly on ward patients. Primary 
      end points were deep vein thrombosis diagnosed by duplex ultrasound and pulmonary 
      embolism diagnosed by computed tomography angiography. RESULTS: Of 495 randomized 
      patients, 220 received UFH and 216 received enoxaparin for analysis. Overall, 105 
      in the UFH group and 103 in the enoxaparin group underwent VTE surveillance or 
      diagnostic testing. In the analysis of randomized patients who received 
      treatment, UFH was noninferior compared with enoxaparin (absolute VTE risk 
      difference, 3.1%; 95% confidence interval, -1.6% to 7.7%; p = 0.196); however, in 
      the screening ultrasound group, the noninferiority of UFH was inconclusive 
      (absolute VTE risk difference, 6.5%; 95% confidence interval, -2.9% to 15.8%; p = 
      0.179). The two treatments did not differ with regard to adverse events. The 
      pharmaceutical cost for the regimen of UFH ($2,809) was nearly 20-fold lower than 
      that for enoxaparin ($54,138). CONCLUSION: A regimen of UFH every 8 hours may be 
      noninferior to enoxaparin every 12 hours for the prevention of VTE following 
      trauma. Given UFH's cost advantage, the use of UFH for VTE prophylaxis may offer 
      greater value. LEVEL OF EVIDENCE: Therapeutic/care management study, level II.
FAU - Olson, Erik J
AU  - Olson EJ
AD  - From the Trauma Service (E.J.O., J.B., R.Y.C., S.R.S., C.E.D., J.-M.V.G., A.L.Z., 
      M.S.B., M.J.B., M.J.S., C.B.S.), and Pharmacy Department (H.S.), Scripps Mercy 
      Hospital, San Diego, California.
FAU - Bandle, Jesse
AU  - Bandle J
FAU - Calvo, Richard Y
AU  - Calvo RY
FAU - Shackford, Steven R
AU  - Shackford SR
FAU - Dunne, Casey E
AU  - Dunne CE
FAU - Van Gent, Jan-Michael
AU  - Van Gent JM
FAU - Zander, Ashley L
AU  - Zander AL
FAU - Sikand, Harminder
AU  - Sikand H
FAU - Bongiovanni, Michael S
AU  - Bongiovanni MS
FAU - Sise, Michael J
AU  - Sise MJ
FAU - Sise, C Beth
AU  - Sise CB
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - United States
TA  - J Trauma Acute Care Surg
JT  - The journal of trauma and acute care surgery
JID - 101570622
RN  - 0 (Anticoagulants)
RN  - 0 (Enoxaparin)
RN  - 9005-49-6 (Heparin)
SB  - IM
MH  - Adult
MH  - Anticoagulants/*therapeutic use
MH  - Enoxaparin/*therapeutic use
MH  - Female
MH  - Heparin/*therapeutic use
MH  - Humans
MH  - Intensive Care Units
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Trauma Centers
MH  - Treatment Outcome
MH  - Ultrasonography, Doppler, Duplex
MH  - Venous Thromboembolism/diagnostic imaging/*etiology/*prevention & control
MH  - Wounds and Injuries/*complications
EDAT- 2015/09/01 06:00
MHDA- 2016/05/06 06:00
CRDT- 2015/08/29 06:00
PHST- 2015/08/29 06:00 [entrez]
PHST- 2015/09/01 06:00 [pubmed]
PHST- 2016/05/06 06:00 [medline]
AID - 10.1097/TA.0000000000000750 [doi]
PST - ppublish
SO  - J Trauma Acute Care Surg. 2015 Dec;79(6):961-8; discussion 968-9. doi: 
      10.1097/TA.0000000000000750.