NCT00135863

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2004

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 26, 2005

Completed
Last Updated

May 21, 2015

Status Verified

January 1, 2004

First QC Date

August 25, 2005

Last Update Submit

May 20, 2015

Conditions

InflammationNutritionPeritoneal Dialysis

Outcome Measures

Primary Outcomes (1)

  • Grade of inflammation, local and systemic

Secondary Outcomes (5)

  • Vascular compliance

  • Nutritional state

  • Efficacy of Peritoneal Dialysis

  • Change in local cellular distribution

  • Change in local and systemic generation of thrombi

Interventions

tinzaparinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • End stage renal disease
  • Peritoneal dialysis without complication for minimum of three months
  • years or above
  • Informed consent

You may not qualify if:

  • Known coagulatory defects including anticoagulation therapy
  • Known bleeding tendency
  • Pregnancy
  • Breast feeding
  • Active infection
  • Non-informed consent
  • Allergy to heparin or prior heparin induced thrombocytopenia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ribe County Hospital

Esbjerg, Ribe, DK-6700, Denmark

Location

MeSH Terms

Conditions

Inflammation

Interventions

Tinzaparin

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Robert S Petersen, MD

    Ribe County Hospital, Department of Nephrology

    STUDY CHAIR

  • Mikkel B Rasmussen, MD

    Ribe County Hospital, Department of Nephrology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 25, 2005

First Posted

August 26, 2005

Study Start

May 1, 2004

Study Completion

May 1, 2005

Last Updated

May 21, 2015

Record last verified: 2004-01

Locations

DK(1)