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MesoHep II: Intraperitoneal Low Molecular Weight Heparin in Peritoneal Dialysis
This study has been terminated.
Sponsors and Collaborators: Ribe County Hospital
LEO Pharma
Coloplast A/S
Information provided by: Ribe County Hospital
ClinicalTrials.gov Identifier: NCT00135863
  Purpose

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
Inflammation
Nutrition
Peritoneal Dialysis
Drug: tinzaparin

MedlinePlus related topics: Blood Thinners Kidney Failure
Drug Information available for: Heparin
U.S. FDA Resources
Study Type: Interventional
Study Design: Educational/Counseling/Training, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Official Title: Intraperitoneal Low Molecular Weight Heparin in Peritoneal Dialysis

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00135863

Locations
Denmark, Ribe
Ribe County Hospital
Esbjerg, Ribe, Denmark, DK-6700
Sponsors and Collaborators
Ribe County Hospital
LEO Pharma
Coloplast A/S
Investigators
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

Study ID Numbers: MesoHep II, 2564-03, 2612-2459
Study First Received: August 25, 2005
Last Updated: December 6, 2005
ClinicalTrials.gov Identifier: NCT00135863  
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics;   Denmark: Danish Medicines Agency

Study placed in the following topic categories:
Body Weight
Heparin, Low-Molecular-Weight
Tinzaparin
Heparin
Calcium heparin
Inflammation

Additional relevant MeSH terms:
Fibrin Modulating Agents
Anticoagulants
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Hematologic Agents
Fibrinolytic Agents
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009