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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01773083
Other study ID # HepBurn
Secondary ID 2012-003289-42
Status Terminated
Phase Phase 3
First received
Last updated
Start date October 2013
Est. completion date December 2017

Study information

Verified date February 2022
Source Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 13
Est. completion date December 2017
Est. primary completion date October 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Intervention

Drug:
unfractionated heparin
nebulized 6 times daily, daily dose 150.000 IU for the maximum duration of 14 days
placebo
Placebo: Sterile saline nebulized 6 times daily for the maximum duration of 14 days

Locations

Country Name City State
Australia St Vincent's Hospital Melbourne Victoria
Belgium Ziekenhuis Netwerk Antwerpen- Stuivenberg Antwerpen
Belgium University Hospital, Gent Gent Oost-Vlaanderen
Belgium University Hospital Gasthuisberg - Leuven Leuven Vlaams-Brabant
Netherlands Academic Medical Center Amsterdam Noord-Holland
Netherlands Red Cross Hospital, Beverwijk, the Netherlands Beverwijk Noord-Holland
Netherlands Martini Hospital Groningen
Netherlands Maasstad Hospital Rotterdam Zuid-Holland

Sponsors (2)

Lead Sponsor Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Dutch Burns Foundation

Countries where clinical trial is conducted

Australia,  Belgium,  Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. at day 28
Secondary 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 daily or at day 28 and day 90
Secondary 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 Blood and lavage samples: on admission day and every other day for a maximum period of 14 days
Secondary 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) daily, for a maximum period of 28 days
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