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

August 25, 2005
December 6, 2005
May 2004
Not Provided
Grade of inflammation, local and systemic
Same as current
Complete list of historical versions of study NCT00135863 on ClinicalTrials.gov Archive Site
  • Vascular compliance
  • Nutritional state
  • Efficacy of Peritoneal Dialysis
  • Change in local cellular distribution
  • Change in local and systemic generation of thrombi
Same as current
Not Provided
Not Provided
 
MesoHep II: Intraperitoneal Low Molecular Weight Heparin in Peritoneal Dialysis
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Educational/Counseling/Training
  • Inflammation
  • Nutrition
  • Peritoneal Dialysis
Drug: tinzaparin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
36
May 2005
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00135863
MesoHep II, 2564-03, 2612-2459
Not Provided
Not Provided
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
Ribe County Hospital
January 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP