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MesoHep II: Intraperitoneal Low Molecular Weight Heparin in Peritoneal Dialysis

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ClinicalTrials.gov Identifier: NCT00135863
Recruitment Status : Terminated
First Posted : August 26, 2005
Last Update Posted : May 21, 2015
LEO Pharma
Coloplast A/S
Information provided by:
Ribe County Hospital

Brief 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.

Condition or disease Intervention/treatment
Inflammation Nutrition Peritoneal Dialysis Drug: tinzaparin

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Official Title: Intraperitoneal Low Molecular Weight Heparin in Peritoneal Dialysis
Study Start Date : May 2004
Estimated Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners
Drug Information available for: Heparin
U.S. FDA Resources

Primary Outcome Measures :
  1. Grade of inflammation, local and systemic

Secondary Outcome Measures :
  1. Vascular compliance
  2. Nutritional state
  3. Efficacy of Peritoneal Dialysis
  4. Change in local cellular distribution
  5. Change in local and systemic generation of thrombi

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00135863     History of Changes
Other Study ID Numbers: MesoHep II
First Posted: August 26, 2005    Key Record Dates
Last Update Posted: May 21, 2015
Last Verified: January 2004

Additional relevant MeSH terms:
Pathologic Processes
Heparin, Low-Molecular-Weight
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action