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TerminatedNCT00135863Updated May 21, 2015

MesoHep II: Intraperitoneal Low Molecular Weight Heparin in Peritoneal Dialysis

An interventional study of tinzaparin in Inflammation, Nutrition and Peritoneal Dialysis, sponsored by Ribe County Hospital. Terminated at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-05-21.

Sponsored by Ribe County Hospital · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Inflammation
  • Nutrition
  • Peritoneal Dialysis

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03

In context

Inflammation

3,439 studies on the registry are indexed under Inflammation; 629 are open to participants now.

This study's enrollment of 36 is below the median of 50 across 2,437 interventional studies indexed under Inflammation.

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Lead sponsor

Ribe County Hospital is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double
Enrollment
36 participants

Interventions

  • Drugtinzaparin
06

What researchers measure

Primary outcomes

  1. Grade of inflammation, local and systemic

Secondary outcomes

  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

07

Study locations

1 site
  • Ribe County Hospital
    Esbjerg, Ribe DK-6700, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 21, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00135863
Lead sponsor
Ribe County Hospital
Collaborators
LEO Pharma, Coloplast A/S
First posted
Aug 26, 2005
Start date
May 2004
Completion
May 2005
Last update
May 21, 2015

Study contacts

Robert S Petersen, MD
study chair · Ribe County Hospital, Department of Nephrology
Mikkel B Rasmussen, MD
principal investigator · Ribe County Hospital, Department of Nephrology
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jan 2004. You cannot join it, but the record below documents what was studied.

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