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Sponsored by: |
Ernst Moritz Arndt University of Greifswald |
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Information provided by: | Ernst Moritz Arndt University of Greifswald |
ClinicalTrials.gov Identifier: | NCT00196469 |
This study is designed to test an incidental finding of a previous trial in which post hoc analysis showed that the rate of intensive care newborns requiring mechanical ventilation was lower in the group receiving heparin with the continuous infusion as compared to the placebo group.
Condition | Intervention | Phase |
---|---|---|
Respiration, Artificial Hemorrhage |
Drug: heparin |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized Double Blind Trial Comparing Heparin and Placebo as Additives to Continuous Infusion in Intensive Care Neonates for Prevention of Ventilation |
Estimated Enrollment: | 270 |
Study Start Date: | December 2003 |
Estimated Study Completion Date: | March 2007 |
Title: Randomized double blind trial comparing heparin and placebo as additives to continuous infusion in intensive care neonates for prevention of mechanical ventilation
Primary endpoint: Percentage of neonates requiring mechanical ventilation in both groups
Secondary endpoints: Duration of dependency on mechanical ventilation; major bleedings, incidence of heparin-induced thrombocytopenia and of anti-platelet factor 4/heparin antibodies
Ages Eligible for Study: | up to 28 Days |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Andreas Greinacher, MD | greinach@uni-greifswald.de |
Germany | |
University Hospital Department of Pediatrics/Institute for Immunology and Transfusion Medicine | Recruiting |
Greifswald, Germany, 17487 | |
Contact: Andreas Greinacher, MD +49 3834-865482 greinach@uni-greifswald.de | |
Contact: Christoph Fusch, MD +49-3834-866420 fusch@uni-greifswald.de | |
Principal Investigator: Andreas Greinacher, MD | |
Principal Investigator: Christoph Fusch, MD | |
Sub-Investigator: Anne F Klenner, MD |
Study Chair: | Andreas Greinacher, MD | Institute for Immunology and Transfusion Medicine, Ernst-Moritz-Arndt-University Greifswald |
Study Director: | Christoph Fusch, MD | Pediatric Department, Ernst-Moritz-Arndt-University Greifswald |
Principal Investigator: | Anne F Klenner, MD | Medical Faculty, Ernst-Moritz-Arndt University Greifswald |
Study ID Numbers: | EMAU16253.00.00 |
Study First Received: | September 12, 2005 |
Last Updated: | October 22, 2007 |
ClinicalTrials.gov Identifier: | NCT00196469 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Fibrin Modulating Agents Anticoagulants Fibrinolytic Agents Cardiovascular Agents |
Hemorrhage Heparin Calcium heparin |
Fibrin Modulating Agents Anticoagulants Pathologic Processes Molecular Mechanisms of Pharmacological Action Therapeutic Uses Hematologic Agents |
Fibrinolytic Agents Cardiovascular Agents Hemorrhage Heparin Pharmacologic Actions |