Impact of Heparin on the Need for Mechanical Ventilation in Neonates

Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00196469
• Other study ID #: EMAU16253.00.00
• Status: Recruiting
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: October 22, 2007
• Start date: December 2003
• Est. completion date: March 2007

Study information

• Verified date: September 2006
• Source: University Medicine Greifswald
• Contact: Andreas Greinacher, MD
• Email: greinach[@]uni-greifswald.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 270
• Est. completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 28 Days

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hemorrhage
• Respiration, Artificial

Intervention

Drug:
• heparin

Locations

Country	Name	City	State
Germany	University Hospital Department of Pediatrics/Institute for Immunology and Transfusion Medicine	Greifswald

Sponsors (1)

Lead Sponsor	Collaborator
University Medicine Greifswald

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of neonates requiring mechanical ventilation
Secondary	duration of dependency on mechanical ventilation
Secondary	major bleeding
Secondary	heparin induced thrombocytopenia
Secondary	anti PF4/heparin antibodies