Trial of Nebulized Heparin Versus Placebo for Inhalation Trauma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2017-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Inhalation Injury Burn Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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unfractionated heparin

25.000 IU/5 ml, will be nebulized 4 hourly (i.e. 6 times daily)

Group Type EXPERIMENTAL

unfractionated heparin

Intervention Type DRUG

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

placebo

Sterile sodium chloride (NaCl 0.9%, Pfizer), in 5 ml, will be nebulized every 4 hours (i.e. 6 times daily)

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

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

Interventions

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unfractionated heparin

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

Intervention Type DRUG

placebo

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

Intervention Type DRUG

Other Intervention Names

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unfractionated heparin sodium, EV Product Code: SUB02475MIG, Marketing Authorisation number: RVG 01372 ATC codes: B01AB01 sterile sodium chloride (NaCl 0.9%)

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No