MesoHep II: Intraperitoneal Low Molecular Weight Heparin in Peritoneal Dialysis

This study has been terminated.
LEO Pharma
Coloplast A/S
Information provided by:
Ribe County Hospital Identifier:
First received: August 25, 2005
Last updated: December 6, 2005
Last verified: January 2004

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.

Condition Intervention
Peritoneal Dialysis
Drug: tinzaparin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Educational/Counseling/Training
Official Title: Intraperitoneal Low Molecular Weight Heparin in Peritoneal Dialysis

Resource links provided by NLM:

Further study details as provided by Ribe County Hospital:

Primary Outcome Measures:
  • Grade of inflammation, local and systemic

Secondary Outcome Measures:
  • Vascular compliance
  • Nutritional state
  • Efficacy of Peritoneal Dialysis
  • Change in local cellular distribution
  • Change in local and systemic generation of thrombi

Estimated Enrollment: 36
Study Start Date: May 2004
Estimated Study Completion Date: May 2005

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its identifier: NCT00135863

Ribe County Hospital
Esbjerg, Ribe, Denmark, DK-6700
Sponsors and Collaborators
Ribe County Hospital
LEO Pharma
Coloplast A/S
Study Chair: Robert S Petersen, MD Ribe County Hospital, Department of Nephrology
Principal Investigator: Mikkel B Rasmussen, MD Ribe County Hospital, Department of Nephrology
  More Information

No publications provided Identifier: NCT00135863     History of Changes
Other Study ID Numbers: MesoHep II, 2564-03, 2612-2459
Study First Received: August 25, 2005
Last Updated: December 6, 2005
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Pathologic Processes
Heparin, Low-Molecular-Weight
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents processed this record on April 22, 2014