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document
Safety and efficacy of a low molecular weight heparin ( Logiparin ) versus dextran as prophylaxis against thrombosis after total hip replacement . In order to study the plasma levels of factor XaI and IIaI activity an enzymatically depolymerized low molecular weight heparin ( LMW-heparin ; Logiparin ) was given s.c. in a dose of 35 XaI mu/kg b.w . once daily for 7 days to 10 patients undergoing total hip replacement ( THR ) in a pilot study . The XaI activity was less than or equal to 0.24 XaI units/ml and the IIaI activity less than or equal to 0.043 IIaI mu/ml . No accumulation of the activities were seen . No phlebographically verified thrombi or any bleeding complications were registered . From this study it was concluded that the given dose of Logiparin was safe with regard to bleeding complications . Based on these data , an open , randomized controlled trial was started . In this main study the thromboprophylactic effect of the LMW-heparin ( Logiparin ) in a dose of 35 XaI mu/kg b.w . once daily was compared with that of dextran 70 in patients undergoing THR . 100 patients were randomized . The over-all thrombosis rate was 28 % in patients treated with LMW-heparin and 39 % in those given dextran , a non-significant difference . No bleeding complications , deaths or pulmonary embolism were recorded in either group . Peroperative blood loss and transfusion requirements were similar in the two groups . In conclusion , the investigated LMW-heparin ( Logiparin ) is safe and effective in preventing postoperative thromboembolism in patients undergoing total hip replacement , but the dosage can probably be optimized .
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Intervention_Pharmacological
enzymatically depolymerized low molecular weight heparin ( LMW-heparin ; Logiparin )
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Outcome_Other
Safety
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Outcome_Other
efficacy
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Outcome_Physical
phlebographically verified thrombi
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Outcome_Physical
bleeding complications
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Outcome_Physical
thromboprophylactic effect
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Outcome_Other
over-all thrombosis rate
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Outcome_Adverse-effects
bleeding complications
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Outcome_Mortality
deaths
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Outcome_Physical
pulmonary embolism
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Outcome_Physical
Peroperative blood loss and transfusion requirements
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Participant_Condition
total hip replacement
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Participant_Sample-size
10
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Participant_Condition
THR
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Participant_Condition
undergoing THR
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Participant_Sample-size
100