Impact of Heparin on the Need for Mechanical Ventilation in Neonates

Randomized Double Blind Trial Comparing Heparin and Placebo as Additives to Continuous Infusion in Intensive Care Neonates for Prevention of Ventilation

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.

Study Overview

• Status: Unknown
• Conditions: Hemorrhage; Respiration, Artificial
• Intervention / Treatment: Drug: heparin

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

• Study Type: Interventional
• Enrollment (Anticipated): 270
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Greifswald, Germany, 17487
    • Recruiting
    • University Hospital Department of Pediatrics/Institute for Immunology and Transfusion Medicine
    • Contact: Andreas Greinacher, MD; Phone Number: +49 3834-865482; Email: greinach@uni-greifswald.de
    • Contact: Christoph Fusch, MD; Phone Number: +49-3834-866420; Email: fusch@uni-greifswald.de
    • Principal Investigator: Andreas Greinacher, MD
    • Principal Investigator: Christoph Fusch, MD
    • Sub-Investigator: Anne F Klenner, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 4 weeks (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
percentage of neonates requiring mechanical ventilation

Secondary Outcome Measures

Outcome Measure
major bleeding
duration of dependency on mechanical ventilation
heparin induced thrombocytopenia
anti PF4/heparin antibodies

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: December 1, 2003
• Study Completion: March 1, 2007

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 20, 2005

Study Record Updates

• Last Update Posted (Estimate): October 23, 2007
• Last Update Submitted That Met QC Criteria: October 22, 2007
• Last Verified: September 1, 2006

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin
• Other Study ID Numbers: EMAU16253.00.00