MesoHep II: Intraperitoneal Low Molecular Weight Heparin in Peritoneal Dialysis

Ribe County Hospital

Status: Terminated

Conditions: Inflammation; Peritoneal Dialysis; Nutrition

Treatments: Drug: tinzaparin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00135863

MesoHep II

2564-03

2612-2459

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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