PMID- 10780310
OWN - NLM
STAT- MEDLINE
DCOM- 20000731
LR  - 20171116
IS  - 0340-6245 (Print)
IS  - 0340-6245 (Linking)
VI  - 83
IP  - 4
DP  - 2000 Apr
TI  - A comparative double-blind, randomised trial of a new second generation LMWH 
      (bemiparin) and UFH in the prevention of post-operative venous thromboembolism. 
      The Bemiparin Assessment group.
PG  - 523-9
AB  - A randomised, prospective, double-blind trial was performed, to compare the 
      safety and efficacy of a new low-molecular-weight heparin (LMWH) Bemiparin and 
      standard unfractionated heparin (UFH), for the prophylaxis of postoperative 
      venous thromboembolism. 300 patients scheduled to undergo elective hip 
      arthroplasty were included. The principal outcome measures were the incidence of 
      thromboembolic events and bleeding complications. 149 patients received 3,500 
      anti-Xa IU of bemiparin plus a placebo injection daily and 149 patients received 
      5,000 IU of UFH twice a day. The two groups were similar with respect to factors 
      likely to affect the risk of developing post-operative venous thromboembolism 
      (VTE) and risk of bleeding events. During the post-operative period, 34 patients 
      developed VTE complications; 9 (7.2%) in the bemiparin group and 25 (18.7%) in 
      the UFH group. VTE in the two groups was statistically significant (OR of 2.96; 
      95% CI 1.32-6.62 and p = 0.01). There were no significant differences in the 
      frequency of bleeding complications: major bleeding requiring discontinuation of 
      prophylaxis, (OR 1.21; 95% CI 0.36-4.05; p = 1.00), the measured median operative 
      blood loss (p = 0.77) or the median postoperative drain loss (p = 0.97), and the 
      number of patients who developed wound haematoma (OR 0.87; 95% CI 0.31-2.46; p = 
      1.00). A comparison of coagulation parameters on the preoperative day with 
      post-operative day 2 +/- 1, day 6 +/- 1 and day of discharge showed a 
      significantly higher AT concentration, anti-factor Xa activity and TFPI levels in 
      the bemiparin group when compared with UFH. This study demonstrates that 
      bemiparin, in a single daily subcutaneous dose of 3,500 anti-Xa IU in high risk 
      patients undergoing hip arthroplasty is more effective than UFH administered 
      twice daily at a dose of 5,000 IU in the prevention of postoperative VTE. Both 
      agents are equally safe.
FAU - Kakkar, V V
AU  - Kakkar VV
AD  - Thrombosis Research Institute, Chelsea, London, UK. director@tri_London.ac.uk
FAU - Howes, J
AU  - Howes J
FAU - Sharma, V
AU  - Sharma V
FAU - Kadziola, Z
AU  - Kadziola Z
LA  - eng
PT  - Clinical Trial
PT  - Comparative Study
PT  - Journal Article
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 (Anticoagulants)
RN  - 0 (Fibrinolytic Agents)
RN  - 0 (Heparin, Low-Molecular-Weight)
RN  - 9005-49-6 (Heparin)
RN  - PUE0TO3XDR (bemiparin)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Anticoagulants/administration & dosage/adverse effects/*therapeutic use
MH  - Arthroplasty, Replacement, Hip
MH  - Double-Blind Method
MH  - Female
MH  - Fibrinolytic Agents/administration & dosage/adverse effects/*therapeutic use
MH  - Follow-Up Studies
MH  - Heparin/administration & dosage/adverse effects/*therapeutic use
MH  - Heparin, Low-Molecular-Weight/administration & dosage/adverse 
      effects/*therapeutic use
MH  - Humans
MH  - Injections, Subcutaneous
MH  - Male
MH  - Middle Aged
MH  - Postoperative Complications/*prevention & control
MH  - Postoperative Hemorrhage/chemically induced
MH  - Prospective Studies
MH  - Pulmonary Embolism/prevention & control
MH  - Risk Factors
MH  - Safety
MH  - Thromboembolism/*prevention & control
MH  - Treatment Outcome
MH  - Venous Thrombosis/*prevention & control
EDAT- 2000/04/26 09:00
MHDA- 2000/08/06 11:00
CRDT- 2000/04/26 09:00
PHST- 2000/04/26 09:00 [pubmed]
PHST- 2000/08/06 11:00 [medline]
PHST- 2000/04/26 09:00 [entrez]
AID - 00040523 [pii]
PST - ppublish
SO  - Thromb Haemost. 2000 Apr;83(4):523-9.