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A multi-center, prospective, open-label, 8-weeks study to investigate the efficacy, safety and pharmacokinetics of certoparin (3000 IU anti-Xa bolus, with the option to titrate dose) in the prophylaxi...

Update Il y a 5 ans
Reference: EUCTR2010-019200-23

A multi-center, prospective, open-label, 8-weeks study to investigate the efficacy, safety and pharmacokinetics of certoparin (3000 IU anti-Xa bolus, with the option to titrate dose) in the prophylaxis of clotting in the extracorporeal circuit in patients undergoing chronic hemodialysis

Woman and Man

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Extract

The primary objective is to investigate the efficacy of certoparin to prevent clotting in the extracorporeal circulation during hemodialysis at week 8. The primary endpoint is the percentage of unsatisfactory dialysis results at visit V4 (wwek 8) due to clotting or bleeding.

Inclusion criteria

  • patients undergoing chronic dialysis

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