Impact of Heparin on the Need for Mechanical Ventilation in Neonates

This study is currently recruiting participants.

Verified by Ernst Moritz Arndt University of Greifswald, September 2006

First Received: September 12, 2005 Last Updated: October 22, 2007 History of Changes

Sponsored by:	Ernst Moritz Arndt University of Greifswald
Information provided by:	Ernst Moritz Arndt University of Greifswald
ClinicalTrials.gov Identifier:	NCT00196469

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 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

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 Ernst Moritz Arndt University of 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

Ernst Moritz Arndt University of 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

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

Study placed in the following topic categories:

Fibrin Modulating Agents
Anticoagulants
Fibrinolytic Agents
Cardiovascular Agents

Hemorrhage
Heparin
Calcium heparin

Additional relevant MeSH terms:

Fibrin Modulating Agents
Anticoagulants
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Hematologic Agents

Fibrinolytic Agents
Cardiovascular Agents
Hemorrhage
Heparin
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 03, 2009