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Trial of Nebulized Heparin Versus Placebo for Inhalation Trauma

Information source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Inhalation Injury; Burn Injury

Intervention: unfractionated heparin (Drug); placebo (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Official(s) and/or principal investigator(s):
Marcus J Schultz, MD-PhD, Principal Investigator, Affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Summary

The purpose of this international multi-center double-blind randomized placebo-controlled trial is to determine the effect of nebulized heparin, compared to placebo, on the number of ventilator-free days at day 28, in burn patients with confirmed inhalation trauma requiring mechanical ventilation.

Clinical Details

Official title: Randomized Controlled Trial Investigating the Efficacy and Safety of Nebulized Heparin Versus Placebo in Burn Patients With Inhalation Trauma (Hepburn)

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Number of ventilator-free days at day 28

Secondary outcome:

Clinical outcome parameters

Laboratory outcome parameters

Safety parameters

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Informed consent

- Age > 18 years

- Need for invasive mechanical ventilation

- Confirmed inhalation trauma (bronchoscopically)

Exclusion Criteria:

- > 36 hours after trauma

- Receiving invasive ventilation > 24 hours

- Expected duration of mechanical ventilation < 24 hours

- Chronic obstructive pulmonary disease GOLD stage III and IV

- Any history of pulmonary hemorrhage in the past 3 months

- Any history of significant bleeding disorder

- Known allergy to heparin, including heparin-induced thrombocytopenia

- Pregnancy or breast feeding

- Unlikely to survive for > 72 hours

- Total body surface area (TBSA) > 60%

- Witnessed or proven aspiration (i. e., confirmed by bronchoscopy)

Locations and Contacts

Ziekenhuis Netwerk Antwerpen- Stuivenberg, Antwerpen 2000, Belgium

Martini Hospital, Groningen 9728 NT, Netherlands

Academic Medical Center, Amsterdam, Noord-Holland 1105 AZ, Netherlands

Red Cross Hospital, Beverwijk, the Netherlands, Beverwijk, Noord-Holland 1942 LE, Netherlands

University Hospital, Gent, Gent, Oost-Vlaanderen 9000, Belgium

St Vincent's Hospital, Melbourne, Victoria 3065, Australia

University Hospital Gasthuisberg - Leuven, Leuven, Vlaams-Brabant 3000, Belgium

Maasstad Hospital, Rotterdam, Zuid-Holland 3079 DZ, Netherlands

Additional Information

HEPBURN website

Starting date: October 2013
Last updated: July 22, 2015

Page last updated: August 23, 2015

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