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January 1, 1999Thrombosis and HaemostasisOpen Access

Prevention of Deep Vein Thrombosis after Hip Replacement

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Why the study?

Does tinzaparin prevent deep vein thrombosis as effectively as enoxaparin in patients undergoing total hip replacement?

Population

499 consecutive patients undergoing total hip replacement across 43 centres

Comparison

Tinzaparin 4,500 anti-Factor IU Xa once daily… vs Enoxaparin 40 mg once daily subcutaneous…

Design

RCT, randomly assigned, blindly assigned, blindly and centrally adjudicated

Follow-up

12-14 days postoperatively

Authors

MSM SamamaUniversité Claude Bernard Lyon 1ALAnthonie W.A. LensingVascular MedicineHBHarry BüllerGeneeskundige en Gezondheidsdienst

Discussion

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Overview

Supports either LMWH for DVT prophylaxis after hip replacement; confirms equivalence of once-daily tinzaparin and enoxaparin in orthopedic surgery.

Key Points

  • To compare the efficacy and safety of once-daily subcutaneous enoxaparin versus tinzaparin for the prevention of deep vein thrombosis after total hip replacement.
  • Randomized, double-blind, multicenter trial across 43 centers enrolling N=499 consecutive patients undergoing total hip replacement.
  • Patients received either enoxaparin (40 mg) or tinzaparin (4,500 anti-Factor Xa IU) as once-daily subcutaneous injections starting 12 hours preoperatively.
  • Efficacy was evaluated by bilateral venography performed 12 to 14 days postoperatively (n=440), with efficacy and safety endpoints blindly and centrally adjudicated.
  • Total incidence of deep vein thrombosis was 20.1% (44/219) with enoxaparin versus 21.7% (48/221) with tinzaparin (upper limit of the 80% CI of the difference was <5.0%, meeting the protocol criteria for equivalence).
  • Proximal deep vein thrombosis occurred in 10.5% (23/219) of patients in the enoxaparin group and 9.5% (21/221) in the tinzaparin group.
  • No overt major bleeding occurred in either group; one patient receiving enoxaparin developed severe thrombocytopenia and died.

Structured PICO

Does tinzaparin prevent deep vein thrombosis as effectively as enoxaparin in patients undergoing total hip replacement?

P
Population
499 consecutive patients undergoing total hip replacement across 43 centres
I
Intervention
Tinzaparin 4,500 anti-Factor IU Xa once daily subcutaneous injection, starting 12 h preoperatively
C
Comparator
Enoxaparin 40 mg once daily subcutaneous injection, starting 12 h preoperatively
O
Outcome
Incidence of deep vein thrombosis (DVT) assessed by bilateral venography at 12-14 days postoperativelysurrogate

Tinzaparin is clinically as effective and safe as enoxaparin for the prophylaxis of deep vein thrombosis after total hip replacement.

Cite This Study

Samama et al. (1999) studied this question.

synapsesocial.com/papers/6a7229ce8031ec7bb1dd42eehttps://doi.org/10.1055/s-0037-1614411
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Prevention of Postoperative Venous Thrombosis: A Randomized Trial Comparing Unfractionated Heparin with Low Molecular Weight Heparin in Patients Undergoing Total Hip Replacement1988 · 256 citations
  2. 2Low molecular weight heparin1992 · 676 citations
  3. 3A Comparison of Recombinant Hirudin with a Low-Molecular-Weight Heparin to Prevent Thromboembolic Complications after Total Hip Replacement1997 · 372 citations
  4. 4Prevention of deep vein thrombosis after total hip replacement. The effect of low-molecular-weight heparin with spinal and general anaesthesia1991 · 77 citations
  5. 5Prophylaxis of postoperative thromboembolism with low molecular weight heparins1993 · 167 citations