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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.
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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| heparin | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| percentage of neonates requiring mechanical ventilation |
| Measure | Description | Time Frame |
|---|---|---|
| duration of dependency on mechanical ventilation | ||
| major bleeding | ||
| heparin induced thrombocytopenia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andreas Greinacher, MD | Contact | greinach@uni-greifswald.de |
| Name | Affiliation | Role |
|---|---|---|
| Andreas Greinacher, MD | Institute for Immunology and Transfusion Medicine, Ernst-Moritz-Arndt-University Greifswald | Study Chair |
| Christoph Fusch, MD | Pediatric Department, Ernst-Moritz-Arndt-University Greifswald |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Department of Pediatrics/Institute for Immunology and Transfusion Medicine | Recruiting | Greifswald | 17487 | Germany |
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| ID | Term |
|---|---|
| D053120 | Respiratory Aspiration |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D006493 | Heparin |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| anti PF4/heparin antibodies |
| Anne F Klenner, MD | Medical Faculty, Ernst-Moritz-Arndt University Greifswald | Principal Investigator |