ClinicalTrials.gov
ClinicalTrials.gov Menu

MesoHep II: Intraperitoneal Low Molecular Weight Heparin in Peritoneal Dialysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00135863
Recruitment Status : Terminated
First Posted : August 26, 2005
Last Update Posted : May 21, 2015
Sponsor:
Collaborators:
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 Phase
Inflammation Nutrition Peritoneal Dialysis Drug: tinzaparin Not Applicable

Study Type : Interventional  (Clinical Trial)
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
Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners
Drug Information available for: Heparin




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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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


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

ClinicalTrials.gov Identifier: NCT00135863     History of Changes
Other Study ID Numbers: MesoHep II
2564-03
2612-2459
First Posted: August 26, 2005    Key Record Dates
Last Update Posted: May 21, 2015
Last Verified: January 2004

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