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Sponsors and Collaborators: |
Ribe County Hospital LEO Pharma Coloplast A/S |
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Information provided by: | Ribe County Hospital |
ClinicalTrials.gov Identifier: | NCT00135863 |
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.
Condition | Intervention |
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Inflammation Nutrition Peritoneal Dialysis |
Drug: tinzaparin |
Study Type: | Interventional |
Study Design: | Educational/Counseling/Training, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | Intraperitoneal Low Molecular Weight Heparin in Peritoneal Dialysis |
Estimated Enrollment: | 36 |
Study Start Date: | May 2004 |
Estimated Study Completion Date: | May 2005 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Denmark, Ribe | |
Ribe County Hospital | |
Esbjerg, Ribe, Denmark, DK-6700 |
Study Chair: | Robert S Petersen, MD | Ribe County Hospital, Department of Nephrology |
Principal Investigator: | Mikkel B Rasmussen, MD | Ribe County Hospital, Department of Nephrology |
Study ID Numbers: | MesoHep II, 2564-03, 2612-2459 |
Study First Received: | August 25, 2005 |
Last Updated: | December 6, 2005 |
ClinicalTrials.gov Identifier: | NCT00135863 |
Health Authority: | Denmark: The Danish National Committee on Biomedical Research Ethics; Denmark: Danish Medicines Agency |
Body Weight Heparin, Low-Molecular-Weight Tinzaparin |
Heparin Calcium heparin Inflammation |
Fibrin Modulating Agents Anticoagulants Pathologic Processes Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Hematologic Agents Fibrinolytic Agents Cardiovascular Agents Pharmacologic Actions |