PMID- 20218984
OWN - NLM
STAT- MEDLINE
DCOM- 20101230
LR  - 20230829
IS  - 1538-7836 (Electronic)
IS  - 1538-7836 (Linking)
VI  - 8
IP  - 6
DP  - 2010 Jun
TI  - A randomized, double-blind study of certoparin vs. unfractionated heparin to 
      prevent venous thromboembolic events in acutely ill, non-surgical patients: 
      CERTIFY Study.
PG  - 1209-15
LID - 10.1111/j.1538-7836.2010.03848.x [doi]
AB  - BACKGROUND: In medically ill patients, no contemporary double-blind head-to-head 
      evaluation of low molecular weight heparin vs. unfractionated heparin (UFH) for 
      the prevention of venous thromboembolic events is available. OBJECTIVES: To 
      compare the efficacy and safety of certoparin with those of UFH. 
      PATIENTS/METHODS: In this double-blind, randomized, controlled trial, acutely 
      ill, non-surgical patients aged > or = 70 years were randomized to certoparin 
      (3000 U of anti-factor Xa once daily) or to UFH (5000 IU t.i.d.). The primary 
      endpoint was the composite of proximal deep vein thrombosis as assessed by 
      bilateral compression ultrasonography, symptomatic non-fatal pulmonary embolism 
      and venous thromboembolism-related death, and was assessed by a blinded central 
      adjudication committee. Non-inferiority margins were set at 1.8 for the odds 
      ratio (OR) and 3.45% for the absolute difference. RESULTS: Three thousand two 
      hundred and thirty-nine patients aged 78.8 + or - 6.3 years were treated for 9.1 
      + or - 3.4 days. The incidence of the primary endpoint was 3.94% in the 
      certoparin group and 4.52% in the UFH group, with a difference in proportions of 
      - 0.59% [95% confidence interval (CI) -2.09 to 0.92; P < 0.0001 for 
      non-inferiority], and an OR of 0.87 (95% CI 0.60-1.26; P = 0.0001 for 
      non-inferiority). Major bleeding occurred in 0.43% of certoparin-treated patients 
      and 0.62% of UFH-treated patients (OR 0.69; 95% CI 0.26-1.83). Any bleeding 
      occurred at 3.20% in certoparin-treated patients vs. 4.58% in UFH-treated 
      patients (OR 0.69; 95% CI 0.48-0.99; P < 0.05), and 5.73% of certoparin-treated 
      patients and 6.63% of UFH-treated patients experienced serious adverse events. 
      All-cause mortality was 1.27% in certoparin-treated patients and 1.36% in 
      UFH-treated patients. CONCLUSIONS: In acutely ill, non-surgical elderly patients, 
      thromboprophylaxis with certoparin (3000 U of anti-FXa once daily) was 
      non-inferior to 5000 IU of UFH t.i.d., with a favorable safety profile.
FAU - Riess, H
AU  - Riess H
AD  - Charite, Campus Virchow Klinikum, Berlin, Germany. hanno.riess@charite.de
FAU - Haas, S
AU  - Haas S
FAU - Tebbe, U
AU  - Tebbe U
FAU - Gerlach, H-E
AU  - Gerlach HE
FAU - Abletshauser, C
AU  - Abletshauser C
FAU - Sieder, C
AU  - Sieder C
FAU - Rossol, S
AU  - Rossol S
FAU - Pfeiffer, B
AU  - Pfeiffer B
FAU - Schellong, S M
AU  - Schellong SM
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20100309
PL  - England
TA  - J Thromb Haemost
JT  - Journal of thrombosis and haemostasis : JTH
JID - 101170508
RN  - 0 (Anticoagulants)
RN  - 0 (Heparin, Low-Molecular-Weight)
RN  - 9005-49-6 (Heparin)
RN  - V72OT3K19I (certoparin)
SB  - IM
MH  - Acute Disease
MH  - Aged
MH  - Anticoagulants/*therapeutic use
MH  - Double-Blind Method
MH  - Heparin/*therapeutic use
MH  - Heparin, Low-Molecular-Weight/*therapeutic use
MH  - Humans
MH  - Thromboembolism/*prevention & control
EDAT- 2010/03/12 06:00
MHDA- 2010/12/31 06:00
CRDT- 2010/03/12 06:00
PHST- 2010/03/12 06:00 [entrez]
PHST- 2010/03/12 06:00 [pubmed]
PHST- 2010/12/31 06:00 [medline]
AID - S1538-7836(22)11423-6 [pii]
AID - 10.1111/j.1538-7836.2010.03848.x [doi]
PST - ppublish
SO  - J Thromb Haemost. 2010 Jun;8(6):1209-15. doi: 10.1111/j.1538-7836.2010.03848.x. 
      Epub 2010 Mar 9.