MesoHep II: Intraperitoneal Low Molecular Weight Heparin in Peritoneal Dialysis

Inflammation Clinical Trial

Official title:

Intraperitoneal Low Molecular Weight Heparin in Peritoneal Dialysis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00135863
• Other study ID #: MesoHep II
• Secondary ID: 2564-032612-2459
• Status: Terminated
• Phase: N/A
• First received: August 25, 2005
• Last updated: May 20, 2015
• Start date: May 2004
• Est. completion date: May 2005

Study information

• Verified date: January 2004
• Source: Ribe County Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 36
• Est. completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Inflammation
• Nutrition
• Peritoneal Dialysis

Intervention

Drug:
• tinzaparin

Locations

Country	Name	City	State
Denmark	Ribe County Hospital	Esbjerg	Ribe

Sponsors (3)

Lead Sponsor	Collaborator
Ribe County Hospital	Coloplast A/S, LEO Pharma

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Grade of inflammation, local and systemic
Secondary	Vascular compliance
Secondary	Nutritional state
Secondary	Efficacy of Peritoneal Dialysis
Secondary	Change in local cellular distribution
Secondary	Change in local and systemic generation of thrombi