Trial of Nebulized Heparin Versus Placebo for Inhalation Trauma (Hepburn)

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

Status and phase: Terminated; Phase 3

Conditions: Inhalation Injury; Burn Injury

Treatments: Drug: unfractionated heparin; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01773083

HepBurn

2012-003289-42 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

13 participants in 2 patient groups, including a placebo group

unfractionated heparin

Experimental group

Description:

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

Treatment:

Drug: unfractionated heparin

placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: placebo