PMID- 12888872
OWN - NLM
STAT- MEDLINE
DCOM- 20040511
LR  - 20171116
IS  - 0340-6245 (Print)
IS  - 0340-6245 (Linking)
VI  - 90
IP  - 2
DP  - 2003 Aug
TI  - Fixed-dose, body weight-independent subcutaneous low molecular weight heparin 
      Certoparin compared with adjusted-dose intravenous unfractionated heparin in 
      patients with proximal deep venous thrombosis.
PG  - 252-9
AB  - Subcutaneous body weight-adjusted low molecular weight heparin (LMWH) has been 
      proven as effective and safe as intravenous aPTT-adjusted unfractionated heparin 
      (UFH) for the treatment of patients with acute deep venous thrombosis (DVT). In 
      this study we evaluate the efficacy of the initial treatment of proximal DVT with 
      a fixed-dose, body weight-independent application of the LMWH Certoparin with a 
      six month follow-up. In a prospective, multicentre, randomized, active-controlled 
      study 1220 patients with objectively diagnosed proximal DVT were randomly 
      assigned to subcutaneous 8000 U anti-factor Xa of Certoparin twice daily for 10 
      to 14 days or intravenous aPTT-adjusted UFH for 5 to 8 days. Both regimen were 
      followed by oral anticoagulation for 6 months. The primary end point was the rate 
      of symptomatic and objectively confirmed thromboembolic events within 6 months. 
      The aim of the study was to demonstrate the non-inferiority of the Certoparin 
      regimen as compared to UFH. The per-protocol analysis revealed 22 (3.8%) 
      thromboembolic events in the Certoparin group and 24 (4.3%) in patients assigned 
      to UFH within 6 months, thereby proving the non-inferiority (p<0.01), confirmed 
      by intent-to-treat analysis (p<0.001). Major bleeding occurred in 6 and 7 
      patients started on Certoparin or UFH during the treatment period. Thromboembolic 
      events were equally distributed in body weight categories with < 50, 50-80 and 
      >80 kg as followed: 0, 3.6% and 4.1% of patients for the Certoparin group and 0, 
      4.6% and 4.2% of patients for the UFH group. The same was true for major bleeding 
      complications with 0, 2.9% and 1.5% for Certoparin and 0, 3.5% and 4.2% for UFH. 
      Overall mortality was 1.9% in the Certoparin group and 2.7% in the UFH group. 
      Fixed-dose body weight-independent subcutaneous LMWH Certoparin is at least as 
      efficacious and safe as intravenous aPTT-adjusted UFH for the initial treatment 
      of acute proximal DVT. This effect is maintained during a 6-months follow-up of 
      treatment with oral anticoagulation.
FAU - Riess, Hanno
AU  - Riess H
AD  - Medical Clinic, Charite University Clinic, Campus Virchow Clinic, Berlin, 
      Germany. hanno.riess@charite.de
FAU - Koppenhagen, Klaus
AU  - Koppenhagen K
FAU - Tolle, Alexander
AU  - Tolle A
FAU - Kemkes-Matthes, Bettina
AU  - Kemkes-Matthes B
FAU - Grave, Michael
AU  - Grave M
FAU - Patek, Frantisek
AU  - Patek F
FAU - Drexler, Michael
AU  - Drexler M
FAU - Siemens, Hans-Joachim G
AU  - Siemens HJ
FAU - Harenberg, Job
AU  - Harenberg J
FAU - Weidinger, Gottfried
AU  - Weidinger G
FAU - Brom, Joachim
AU  - Brom J
FAU - Haas, Sylvia
AU  - Haas S
CN  - TH-4 Study Group
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - Germany
TA  - Thromb Haemost
JT  - Thrombosis and haemostasis
JID - 7608063
RN  - 0 (Heparin, Low-Molecular-Weight)
RN  - 9005-49-6 (Heparin)
RN  - V72OT3K19I (certoparin)
SB  - IM
CIN - Thromb Haemost. 2003 Aug;90(2):165-6. PMID: 12888863
MH  - Aged
MH  - Body Weight
MH  - Dose-Response Relationship, Drug
MH  - Female
MH  - Hemorrhage/chemically induced
MH  - Heparin/*administration & dosage/adverse effects
MH  - Heparin, Low-Molecular-Weight/*administration & dosage/adverse effects
MH  - Humans
MH  - Injections, Intravenous
MH  - Injections, Subcutaneous
MH  - Male
MH  - Middle Aged
MH  - Recurrence
MH  - Thrombocytopenia/chemically induced
MH  - Venous Thrombosis/*drug therapy
EDAT- 2003/07/31 05:00
MHDA- 2004/05/12 05:00
CRDT- 2003/07/31 05:00
PHST- 2003/07/31 05:00 [pubmed]
PHST- 2004/05/12 05:00 [medline]
PHST- 2003/07/31 05:00 [entrez]
AID - 03080252 [pii]
AID - 10.1160/TH02-09-0061 [doi]
PST - ppublish
SO  - Thromb Haemost. 2003 Aug;90(2):252-9. doi: 10.1160/TH02-09-0061.