A Phase 3 interventional study of Heparin and Normal Saline in Smoke Inhalation Injury and Acute Lung Injury, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-12.
Sponsored by Ain Shams University · Phase 3, Interventional, and Prevention
This study aims to examine the effects of nebulized heparin on the clinical outcomes in adult patients suffering smoke inhalation injury.
Patients will be randomized to receive nebulized heparin or an equal volume of normal saline for 14 days and the incidence of acute lung injury will be compared in either group.
Adult patients who suffered smoke inhalation injury and who are candidates for elective intubation, have evidence of bronchial burn by fiberoptic bronchoscopy, have no evidence of acute lung injury and no more than 24 hours since inhalation injury will be included.
Patients will be randomized into 2 groups:
Group A (Intervention): Patients will receive 5000 IU heparin mixed with 3 ml saline and nebulized every 4 hours until they are extubated or until 14 days have elapsed whichever is earlier.
Group B (Control): Patients will receive 4 ml of normal saline nebulized every 4 hours until they are extubated or until 14 days have elapsed whichever is earlier.
The primary end point is the VFDs.
1,092 studies on the registry are indexed under Respiratory Aspiration; 216 are open to participants now.
This study's enrollment of 88 is above the median of 42 across 881 interventional studies indexed under Respiratory Aspiration.
Browse Respiratory Aspiration studies →Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Massive injury: evidence of mucosal sloughing, necrosis or endoluminal obliteration.
Exclusion Criteria:
Heparin is nebulized via endotracheal tube
Drug: Heparin
Normal saline is nebulized via endotracheal tube
Other: Normal Saline
Heparin sodium (Generic, 5000 IU/ml ampoules)
0.9% sodium chloride solution (normal saline)
Also known as: Saline
VFDs
Number of days free of mechanical ventilation
Time frame: 28 days
ICU-free days
Number of days free from ICU and alive
Time frame: 28 days
Duration of mechanical ventilation
Time from institution to termination of mechanical ventilation
Time frame: 28 days
Mortality
Survival to ICU discharge
Time frame: 28 days
Side effects
Occurrence of heparin-induced adverse effects, e.g., thrombocytopenia, abnormal bleeding
Time frame: 28 days
P/F ratio
PaO2/FiO2
Time frame: 14 days
Plan to share: No
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Ain Shams University