MesoHep II: Intraperitoneal Low Molecular Weight Heparin in Peritoneal Dialysis

• Status: Terminated
• Trial end date: 2005-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients with end stage renal disease (ESRD) who use peritoneal dialyses with Physioneal(R) (Baxter A/S, Denmark) were allocated to inject either placebo or tinzaparin daily into the morning dialysis bag. Active medication, as well as placebo, was added for three months separated by a one month washout period. At the beginning and end of each treatment period peritoneal equilibrations tests (PE-tests), Kt/V, blood and dialysate samples were analyzed. We, the researchers at Ribe County Hospital, set out to examine inflammation (local and systemic), nutrition and ultrafiltration.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ribe County Hospital
• Collaborators: Coloplast A/S; LEO Pharma
• Treatments: Dalteparin; Heparin; Heparin, Low-Molecular-Weight; Tinzaparin

Criteria

Inclusion Criteria:

• End stage renal disease

• Peritoneal dialysis without complication for minimum of three months

• 18 years or above

• Informed consent

Exclusion Criteria:

• Known coagulatory defects including anticoagulation therapy

• Known bleeding tendency

• Peritonitis within two months prior to inclusion

• Pregnancy

• Breast feeding

• Active infection

• Non-informed consent

• Allergy to heparin or prior heparin induced thrombocytopenia