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MesoHep II: Intraperitoneal Low Molecular Weight Heparin in Peritoneal Dialysis

This study has been terminated.
Sponsor:
Collaborators:
LEO Pharma
Coloplast A/S
Information provided by:
Ribe County Hospital
ClinicalTrials.gov Identifier:
NCT00135863
First received: August 25, 2005
Last updated: December 6, 2005
Last verified: January 2004
History of Changes
  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

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:

U.S. FDA Resources

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 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

No publications provided

ClinicalTrials.gov 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:
Inflammation
Pathologic Processes
Heparin, Low-Molecular-Weight
Dalteparin
Tinzaparin
Anticoagulants
Hematologic Agents
 Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on June 18, 2013