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Impact of Heparin on the Need for Mechanical Ventilation in Neonates

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by University Medicine Greifswald.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Medicine Greifswald
ClinicalTrials.gov Identifier:
NCT00196469
First received: September 12, 2005
Last updated: October 22, 2007
Last verified: September 2006
History of Changes
  Purpose

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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Randomized Double Blind Trial Comparing Heparin and Placebo as Additives to Continuous Infusion in Intensive Care Neonates for Prevention of Ventilation

Resource links provided by NLM:

MedlinePlus related topics: Blood Thinners
Drug Information available for: Heparin
U.S. FDA Resources

Further study details as provided by University Medicine Greifswald:

Primary Outcome Measures:
  • percentage of neonates requiring mechanical ventilation

Secondary Outcome Measures:
  • duration of dependency on mechanical ventilation
  • major bleeding
  • heparin induced thrombocytopenia
  • anti PF4/heparin antibodies

Estimated Enrollment: 270
Study Start Date: December 2003
Estimated Study Completion Date: March 2007
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   up to 28 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newborns < day 28 of life
  • Necessity for intensive care treatment
  • Necessity for parenteral drug or fluid application for at least five days
  • Informed consent of parents

Exclusion Criteria:

  • Body weight < 500g
  • Mechanical ventilation directly after birth
  • Major malformations
  • Absolute indication for heparin
  • Inborn hemorrhagic disease (e.g. hemophilia, von Willebrand disease)
  • Cerebral bleeding or other major bleeding
  • Platelet count < 50,000/µl
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00196469

Contacts
Contact: Andreas Greinacher, MD greinach@uni-greifswald.de

Locations
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            
Sponsors and Collaborators
University Medicine Greifswald
Investigators
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00196469     History of Changes
Other Study ID Numbers: EMAU16253.00.00
Study First Received: September 12, 2005
Last Updated: October 22, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes
Calcium heparin
Heparin
Anticoagulants
Hematologic Agents
 Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on June 18, 2013