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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003289-42 | EudraCT Number |
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insufficient recruitment of patients and high costs associated with the purchase and blinding of study medication
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| Name | Class |
|---|---|
| Dutch Burns Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| unfractionated heparin | Experimental | 25.000 IU/5 ml, will be nebulized 4 hourly (i.e. 6 times daily) |
|
| placebo | Placebo Comparator | Sterile sodium chloride (NaCl 0.9%, Pfizer), in 5 ml, will be nebulized every 4 hours (i.e. 6 times daily) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| unfractionated heparin | Drug | nebulized 6 times daily, daily dose 150.000 IU for the maximum duration of 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marcus J Schultz, MD-PhD | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Vincent's Hospital | Melbourne | Victoria | 3065 | Australia | ||
| University Hospital, Gent |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24661817 | Derived | Glas GJ, Muller J, Binnekade JM, Cleffken B, Colpaert K, Dixon B, Juffermans NP, Knape P, Levi MM, Loef BG, Mackie DP, Malbrain M, Schultz MJ, van der Sluijs KF. HEPBURN - investigating the efficacy and safety of nebulized heparin versus placebo in burn patients with inhalation trauma: study protocol for a multi-center randomized controlled trial. Trials. 2014 Mar 25;15:91. doi: 10.1186/1745-6215-15-91. |
| Label | URL |
|---|---|
| HEPBURN website | View source |
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| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D006493 | Heparin |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D002712 | Chlorides |
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| placebo | Drug | Placebo: Sterile saline nebulized 6 times daily for the maximum duration of 14 days |
|
|
| 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 | 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) | daily, for a maximum period of 28 days |
| Ghent |
| Oost-Vlaanderen |
| 9000 |
| Belgium |
| University Hospital Gasthuisberg - Leuven | Leuven | Vlaams-Brabant | 3000 | Belgium |
| Ziekenhuis Netwerk Antwerpen- Stuivenberg | Antwerp | 2000 | Belgium |
| Academic Medical Center | Amsterdam | North Holland | 1105 AZ | Netherlands |
| Red Cross Hospital, Beverwijk, the Netherlands | Beverwijk | North Holland | 1942 LE | Netherlands |
| Maasstad Hospital | Rotterdam | South Holland | 3079 DZ | Netherlands |
| Martini Hospital | Groningen | 9728 NT | Netherlands |
| D006851 |
| Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |