MesoHep II: Intraperitoneal Low Molecular Weight Heparin in Peritoneal Dialysis

May 20, 2015 updated by: Ribe County Hospital

Intraperitoneal Low Molecular Weight Heparin in Peritoneal Dialysis

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Ribe
      • Esbjerg, Ribe, Denmark, DK-6700
        • Ribe County Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Grade of inflammation, local and systemic

Secondary Outcome Measures

Outcome Measure
Vascular compliance
Nutritional state
Efficacy of Peritoneal Dialysis
Change in local cellular distribution
Change in local and systemic generation of thrombi

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ribe County Hospital

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Study Completion

May 1, 2005

Study Registration Dates

First Submitted

August 25, 2005

First Submitted That Met QC Criteria

August 25, 2005

First Posted (Estimate)

August 26, 2005

Study Record Updates

Last Update Posted (Estimate)

May 21, 2015

Last Update Submitted That Met QC Criteria

May 20, 2015

Last Verified

January 1, 2004

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MesoHep II
  • 2564-03
  • 2612-2459

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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