PMID- 21505722
OWN - NLM
STAT- MEDLINE
DCOM- 20111027
LR  - 20171116
IS  - 2567-689X (Electronic)
IS  - 0340-6245 (Linking)
VI  - 105
IP  - 6
DP  - 2011 Jun
TI  - CERTIFY: prophylaxis of venous thromboembolism in patients with severe renal 
      insufficiency.
PG  - 981-8
LID - 10.1160/TH10-09-0614 [doi]
AB  - Patients with severe renal insufficiency (sRI) have been suggested to be at an 
      increased risk of bleeding with low-molecular-weight heparins (LMWH). We aimed at 
      assessing the benefits and risks of certoparin in comparison to unfractionated 
      heparin (UFH) in these patients. In this subgroup analysis of the CERTIFY trial, 
      acutely ill, non-surgical patients >/=70 years received certoparin 3,000U aXa o.d. 
      or UFH 5,000 IU t.i.d. One hundred eighty-nine patients had a glomerular 
      filtration rate (GFR) </=30 ml/min/1.73 m2, 3,050 patients served as controls. 
      Patients with sRI had a mean age of 85.9 +/- 6.6 years (controls 78.4 +/- 6.0) and 
      were treated for a mean of 9.3 +/- 3.7 days (9.9 +/- 4.3). Thromboembolic event rates 
      were comparable (4.55 vs. 4.21%; OR1.08; 95%CI 0.5-2.37) but bleeding was 
      increased in sRI (9.52 vs. 3.54%; OR2.87; 95%CI 1.70-4.83). The incidence of the 
      combined end-point of proximal DVT, symptomatic non-fatal PE and VTE related 
      death was 6.49% with certoparin and 2.60% with UFH (OR2.60; 95%CI 0.49-13.85). 
      There was a decrease in total bleeding with certoparin (OR0.33; 95%CI 0.11-0.97), 
      which was non-significant in patients with GFR >30 ml/min/1.73 m2. In two 
      multivariable regression models certoparin and immobilisation <10 days were 
      associated with less bleeding while a GFR </=30 ml/min/1.73 m2 was associated with 
      increased bleeding. A total of 11.3% of certoparin- and 18.5% of UFH-treated 
      patients experienced serious adverse events (14.8 in patients with a GFR </=30 vs. 
      5.6% vs. >30 ml/min/1.73 m2). In conclusion, certoparin 3,000U anti Xa o.d. was 
      as efficacious as 5,000 IU UFH t.i.d. in patients with sRI but had a reduced risk 
      of bleeding.
FAU - Bauersachs, R
AU  - Bauersachs R
AD  - Medizinische Klinik IV, Max-Ratschow-Klinik fur Angiologie, Klinikum Darmstadt 
      GmbH, Grafenstrasse 9, 64283 Darmstadt, Germany. bauersachs@em.uni-frankfurt.de
FAU - Schellong, S M
AU  - Schellong SM
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 - Melzer, N
AU  - Melzer N
FAU - Bramlage, P
AU  - Bramlage P
FAU - Riess, H
AU  - Riess H
LA  - eng
SI  - ClinicalTrials.gov/NCT00451412
PT  - Clinical Trial
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20110420
PL  - Germany
TA  - Thromb Haemost
JT  - Thrombosis and haemostasis
JID - 7608063
RN  - 0 (Anticoagulants)
RN  - 0 (Heparin, Low-Molecular-Weight)
RN  - 9005-49-6 (Heparin)
RN  - V72OT3K19I (certoparin)
SB  - IM
MH  - Acute Kidney Injury/blood/*drug therapy/epidemiology
MH  - Aged
MH  - Aged, 80 and over
MH  - Anticoagulants/*administration & dosage/adverse effects
MH  - Female
MH  - Germany
MH  - Hemorrhage/etiology/prevention & control
MH  - Heparin/administration & dosage/adverse effects
MH  - Heparin, Low-Molecular-Weight/*administration & dosage/adverse effects
MH  - Humans
MH  - Incidence
MH  - Male
MH  - Risk Assessment
MH  - Venous Thromboembolism/prevention & control
EDAT- 2011/04/21 06:00
MHDA- 2011/10/28 06:00
CRDT- 2011/04/21 06:00
PHST- 2010/09/27 00:00 [received]
PHST- 2011/03/05 00:00 [accepted]
PHST- 2011/04/21 06:00 [entrez]
PHST- 2011/04/21 06:00 [pubmed]
PHST- 2011/10/28 06:00 [medline]
AID - 10-09-0614 [pii]
AID - 10.1160/TH10-09-0614 [doi]
PST - ppublish
SO  - Thromb Haemost. 2011 Jun;105(6):981-8. doi: 10.1160/TH10-09-0614. Epub 2011 Apr 
      20.