Study of the effectiveness and safety of heparin inhalation to treat lung coagulation disturbances in burn patients with inhalation trauma.

Randomized Controlled Trial Investigating the Efficacy and Safety of Nebulized Heparin versus Placebo in Burn Patients with Inhalation Trauma - Hepburn study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-003289-42-NL

Enrollment

118

Registered

2012-12-21

Start date

2012-12-21

Completion date

Unknown

Last updated

2015-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burn-associated inhalation trauma requiring intubation and mechanical ventilation.

Interventions

Trade Name: unfractionated heparin sodium Product Name: unfractionated heparin sodium Pharmaceutical Form: Infusion INN or Proposed INN: unfractionated heparin sodium CAS Number: 9005-49-6 Current Spo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - informed consent - age > 18 years - need for invasive mechanical ventilation - clinical diagnosis of inhalation trauma: initially on basis of indirect observations, followed by confirmation through bronchoscopy Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 85 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 33

Exclusion criteria

Exclusion criteria: - > 36 hours after trauma - Receiving invasive ventilation > 24 hours - Expected duration of mechanical ventilation 72 hours - Total body surface area (TBSA) > 60% - Witnessed or proven aspiration (i.e., confirmed by bronchoscopy)

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine the effect of nebulized heparin on duration of mechanical ventilation in burn patients with confirmed inhalation trauma.;Secondary Objective: • To determine the effect of nebulized heparin on relevant and frequently–used outcome parameters. • To determine the effect of nebulized heparin on pulmonary coagulation and fibrinolysis, and pulmonary inflammation. • To determine safety of nebulized heparin ;Primary end point(s): Number of ventilator-free days during the first 28 days after inclusion;Timepoint(s) of evaluation of this end point: Daily. Moment of successful detubation (at least 24 hours free of mechanical ventilation) in a 28-day periode	—

Measure

Time frame

Main Objective: To determine the effect of nebulized heparin on duration of mechanical ventilation in burn patients with confirmed inhalation trauma.;Secondary Objective: • To determine the effect of nebulized heparin on relevant and frequently–used outcome parameters. • To determine the effect of nebulized heparin on pulmonary coagulation and fibrinolysis, and pulmonary inflammation. • To determine safety of nebulized heparin ;Primary end point(s): Number of ventilator-free days during the first 28 days after inclusion;Timepoint(s) of evaluation of this end point: Daily. Moment of successful detubation (at least 24 hours free of mechanical ventilation) in a 28-day periode

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Secondary

Measure	Time frame
Secondary end point(s): - clinical parameters such as Lung Injury Score (LIS), ICU length-of-stay (LOS), 28- and 90-day mortality, sedation, number of bronchoscopies performed to remove foreign particles and accumulated secretions , incidence of pneumonia. - pulmonary coagulation and fibrinolysis in burn patients with inhalation trauma as reflected by tissue factor, activated factor VII, antithrombin, thrombin-antithrombin complexes and activated protein C, plasminogen activator activity, tissue plasminogen activator, urokinase plasminogen activator and plasminogen activator inhibitor 1, and FDP in BALF. - pulmonary inflammation in burn patients with inhalation trauma as reflected by IL–1 beta, IL–6, IL-8, IL-10, TNF-alpha, VEGF and TGF-beta. - Occurence and severety of bleeding events;Timepoint(s) of evaluation of this end point: - Clinical parameters: daily routine clinical data collection - pulmonary coagulation, fibrinolysis and inflammation: blood and BAL sampling will be performed every other day	—

Measure

Time frame

Secondary end point(s): - clinical parameters such as Lung Injury Score (LIS), ICU length-of-stay (LOS), 28- and 90-day mortality, sedation, number of bronchoscopies performed to remove foreign particles and accumulated secretions , incidence of pneumonia. - pulmonary coagulation and fibrinolysis in burn patients with inhalation trauma as reflected by tissue factor, activated factor VII, antithrombin, thrombin-antithrombin complexes and activated protein C, plasminogen activator activity, tissue plasminogen activator, urokinase plasminogen activator and plasminogen activator inhibitor 1, and FDP in BALF. - pulmonary inflammation in burn patients with inhalation trauma as reflected by IL–1 beta, IL–6, IL-8, IL-10, TNF-alpha, VEGF and TGF-beta. - Occurence and severety of bleeding events;Timepoint(s) of evaluation of this end point: - Clinical parameters: daily routine clinical data collection - pulmonary coagulation, fibrinolysis and inflammation: blood and BAL sampling will be performed every other day

—

Countries

Belgium, Netherlands

Contacts

Public ContactGlas G.J.

Academic Medical Center Amsterdam

g.j.glas@amc.uva.nl0031205668222

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026