Trial of Nebulized Heparin Versus Placebo for Inhalation Trauma

Phase 3TerminatedNCT01773083

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)13 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Inhalation Injury Burn Injury

Interventions

unfractionated heparinDRUG

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

placeboDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 (8)

St Vincent's Hospital

Melbourne, Victoria, Australia

University Hospital, Gent

Ghent, Oost-Vlaanderen, Belgium

University Hospital Gasthuisberg - Leuven

Leuven, Vlaams-Brabant, Belgium

Ziekenhuis Netwerk Antwerpen- Stuivenberg

Antwerp, Belgium

Outcomes

Primary Outcomes

Number of ventilator-free days at day 28

The number of ventilator-free days is defined as the number of days a patient is breathing without assist of a ventilator during the first 28 days; thus, the patient must be free of mechanical ventilation for 24 hours to have one ventilator-free day; if after successful detubation the patient requires a reintubation due to a surgical procedure, this reintubation will not count as a ventilator day - however, the day(s) will be counted as ventilator day(s) if mechanical ventilation is prolonged after surgery due to respiratory insufficiency.

Time frame: at day 28

Secondary Outcomes

Clinical outcome parameters

Clinical outcome parameters will include but not be restricted to: (a) length of stay (ICU and hospital); (b) mortality (28- and 90 days); (c) mortality (ICU and hospital); (d) daily Lung Injury Score (LIS); (e) daily Oxygenation Index (OI) ; (f) daily Sequential Organ Failure Assessment (SOFA)-scores ; (g) cumulative dosages of sedatives; (h) incidence of Ventilator-associated Pneumonia (VAP); (i) total number of bronchoscopy-guided cleaning of the larger airway

Time frame: daily or at day 28 and day 90

Laboratory outcome parameters

Levels of markers of coagulation and fibrinolysis in blood and lung lavage fluid, Levels of markers of inflammation in blood and lung lavage fluid, Biomarkers of lung injury in blood and lung lavage fluid

Time frame: Blood and lavage samples: on admission day and every other day for a maximum period of 14 days

Safety parameters

Safety parameters will include but not be restricted to: Occurrence of serious bleedings, any other transfusion of blood products - red cells and/or platelets and/or plasma, Confirmed Heparin induced thrombocytopenia, prolonged activated partial thromboplastin time (aPTT \> 150 seconds)

Time frame: daily, for a maximum period of 28 days

Data from ClinicalTrials.gov

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