MesoHep II: Intraperitoneal Low Molecular Weight Heparin in Peritoneal Dialysis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2005-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Inflammation Nutrition Peritoneal Dialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Interventions

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tinzaparin

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No