Trial of Nebulized Heparin Versus Placebo for Inhalation Trauma

Burn Injury Clinical Trial

— Hepburn  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01773083
• Other study ID #: HepBurn
• Secondary ID: 2012-003289-42
• Status: Terminated
• Phase: Phase 3
• 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
• 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)

Related Conditions & MeSH terms

• Burn Injury
• Inhalation Injury
• Respiratory Aspiration
• Wounds and Injuries

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

External Links

•   HEPBURN website