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Trial of Nebulized Heparin Versus Placebo for Inhalation Trauma

NCT01773083 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2022-02-16

No results posted yet for this study

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.

Conditions

  • Inhalation Injury
  • Burn Injury

Interventions

DRUG

unfractionated heparin

nebulized 6 times daily, daily dose 150.000 IU for the maximum duration of 14 days

DRUG

placebo

Placebo: Sterile saline nebulized 6 times daily for the maximum duration of 14 days

Sponsors & Collaborators

  • Dutch Burns Foundation

    collaborator OTHER

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    lead OTHER

Principal Investigators

  • Marcus J Schultz, MD-PhD · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2016-10-31
Completion
2017-12-31

Countries

  • Australia
  • Belgium
  • Netherlands

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01773083 on ClinicalTrials.gov