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document
Tinzaparin versus dalteparin for periprocedure prophylaxis of thromboembolic events in hemodialysis patients : a randomized trial . BACKGROUND Low-molecular-weight heparin ( LMWH ) is cleared predominantly by the kidneys and hence there is uncertainty about the safety of its use in hemodialysis ( HD ) patients . Our primary objective was to compare whether tinzaparin and dalteparin differentially accumulate in HD patients . STUDY DESIGN Open-label randomized controlled trial . SETTING & PARTICIPANTS HD patients undergoing periprocedure bridging anticoagulation . INTERVENTION After warfarin therapy was discontinued , participants were randomly assigned to either 3 daily doses of tinzaparin ( 175 IU/kg ) or dalteparin ( 200 IU/kg ) , with 2 intervening HD treatments between the first dose of study drug and their procedure . OUTCOMES The primary outcome was predialysis anti-Xa levels 20 to 24 hours after the third LMWH dose ( therapeutic target , < 0.2 IU/mL ) . Secondary outcomes included thromboembolic events and major bleeding . RESULTS Of 29 eligible and consenting patients , 17 patients received tinzaparin and 12 patients received dalteparin . Mean predialysis anti-Xa level 20-24 hours after the third LMWH dose was 0.37 ± 0.23 ( SD ) IU/mL for tinzaparin and 0.62 ± 0.41 IU/mL for dalteparin ( P = 0.1 ) , indicating clinically important accumulation for both drugs . No invasive procedures were canceled due to study drug accumulation . 4 patients experienced serious adverse events ( 1 major bleed after traumatic arteriovenous fistula puncture in the tinzaparin arm , 2 non-ST-elevation myocardial infarctions [ 1 in each group ] , and 1 upper-extremity deep venous thrombosis [ dalteparin group ] ) . LIMITATIONS Small sample size . CONCLUSIONS Dalteparin and tinzaparin significantly accumulate in HD patients at therapeutic doses . " Bridging therapy " with LMWHs at therapeutic doses in HD patients who require temporary interruption of warfarin therapy has the potential for complications and is of uncertain benefit . Other anticoagulation strategies , including no bridging therapy or intravenous heparin , need comparative evaluation in this unique patient population .
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Intervention_Pharmacological
Tinzaparin
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Intervention_Pharmacological
dalteparin
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Intervention_Pharmacological
Low-molecular-weight heparin ( LMWH )
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Intervention_Pharmacological
tinzaparin
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Intervention_Pharmacological
dalteparin
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Intervention_Pharmacological
warfarin therapy
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Intervention_Pharmacological
3 daily doses of tinzaparin ( 175 IU/kg )
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Intervention_Pharmacological
dalteparin
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Intervention_Pharmacological
tinzaparin
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Intervention_Pharmacological
dalteparin
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Intervention_Pharmacological
dalteparin
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Outcome_Physical
predialysis anti-Xa levels 20 to 24 hours after the third LMWH dose
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Outcome_Physical
thromboembolic events and major bleeding
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Outcome_Physical
Mean predialysis anti-Xa level 20-24 hours
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Participant_Condition
hemodialysis
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Participant_Condition
hemodialysis ( HD )
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Participant_Condition
HD patients .
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Participant_Condition
HD
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Participant_Condition
anticoagulation
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Participant_Sample-size
29