Smoke Inhalation InjuryPhase 3NCT05886998
Nebulized Heparin for Prevention of Acute Lung Injury in Smoke Inhalation Injury
A Phase 3 study testing Heparin and Normal Saline in people with Smoke Inhalation Injury and Acute Lung Injury, run by Ain Shams University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoke Inhalation Injury, Acute Lung Injury
- What is being tested?
- Heparin and Normal Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2023to 3 Jun 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Adult patients indicated for elective intubation:
- History of being trapped in a house or industrial fire.
- Production of carbonaceous sputum.
- Perioral facial burns affecting nose, lips, mouth, or throat .
- Altered level of consciousness at any time after the incident and including confusion.
- Symptoms of respiratory distress including a sense of suffocation, choking, breathlessness, and wheezing or discomfort affecting the eyes or throat, including irritation of the mucosal membranes.
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- Signs of respiratory distress including stertorous or labored breathing, and tachypnea or auscultatory abnormalities, including crepitations or rhonchi.
- Hoarseness or loss of voice. 2. Evidence of bronchial burn by bronchoscopy to assess severity of inhalational trauma
- NO injury: absence of carbonaceous deposits, erythema, oedema, brochorrhea, or obstruction.
- Mild injury: minor patchy areas of erythema or carbonaceous deposits in proximal or distal bronchi.
- Moderate injury: moderate degree of erythema, carbonaceous deposits, bronchorrhea, or bronchial obstructions.
- Sever injury: sever inflammation with friability, copious carbonaceous deposits, bronchorrhea, or obstruction.
- Massive injury: evidence of mucosal sloughing, necrosis or endoluminal obliteration.
- 3. No evidence of acute lung injury at presentation (either by radiology or ABG)
- Radiological findings: Normal lung without increased interstitial markings, ground glass opacification, or consolidation.
- ABG findings : PaO2/ Fio2 > 300. 4. Time between inhalational injury and intubation not longer than 24 hours.
Who cannot join
- Burn injury > 24 hours.
- History of pulmonary diseases.
- Pregnancy or breast feeding.
- History of allergy to heparin or HIT.
- History or laboratory evidence of coagulopathy.
- Burns area > 50% of total body surface area. -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nebulized Heparin for Prevention of Acute Lung Injury in Adult Patients Suffering Smoke Inhalation Injury: a Randomized Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Smoke Inhalation Injury, Acute Lung Injury
- Being tested
- Heparin, Normal Saline
- Keywords
- Smoke Inhalation Injury, Acute Lung Injury, Heparin
- Medical subject headings
- Smoke Inhalation Injury, Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeparinDrug
Heparin sodium (Generic, 5000 IU/ml ampoules)
Normal SalineOther
Also called Saline
0.9% sodium chloride solution (normal saline)
| Study group | Role | What they receive |
|---|---|---|
| Group A (Nebulized Heparin) | Experimental | Heparin is nebulized via endotracheal tube Receives: Drug: Heparin |
| Group B (Nebulized Saline) | Placebo comparator | Normal saline is nebulized via endotracheal tube Receives: Other: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
VFDs
Number of days free of mechanical ventilation
Measured: 28 days
Secondary outcomes (5)
ICU-free days
Number of days free from ICU and alive
Measured: 28 days
Duration of mechanical ventilation
Time from institution to termination of mechanical ventilation
Measured: 28 days
Mortality
Survival to ICU discharge
Measured: 28 days
Side effects
Occurrence of heparin-induced adverse effects, e.g., thrombocytopenia, abnormal bleeding
Measured: 28 days
P/F ratio
PaO2/FiO2
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start1 Jun 2023
- Primary completion3 Jun 2024
- Study completion3 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoke Inhalation InjuryStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameh M. Hakim, Ain Shams University
- Investigators
- Sameh M Hakim, MD, Principal investigator, Ain Shams University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05886998
- Sponsor's protocol ID
- FMASU MD 238/2020
- Status last verified
- Jul 2024
- First submitted
- 22 May 2023
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Murray JF, Matthay MA, Luce JM, Flick MR. An expanded definition of the adult respiratory distress syndrome. Am Rev Respir Dis. 1988 Sep;138(3):720-3. doi: 10.1164/ajrccm/138.3.720. No abstract available.
PubMed 3202424
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nebulized Heparin for Prevention of Acute Lung Injury in Adult Patients Suffering Smoke Inhalation Injury: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05886998
- Acronym / sponsor ID
- FMASU MD 238/2020
- Conditions
- Smoke Inhalation Injury, Acute Lung Injury
- Keywords
- Smoke Inhalation Injury, Acute Lung Injury, Heparin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 3 Jun 2024 (actual)
- Study completion
- 3 Jun 2024 (actual)
- First posted
- 2 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Nebulized Heparin) | Experimental | Drug: HeparinHeparin is nebulized via endotracheal tube |
| Group B (Nebulized Saline) | Placebo comparator | Other: Normal SalineNormal saline is nebulized via endotracheal tube |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- History of being trapped in a house or industrial fire.
- Production of carbonaceous sputum.
- Perioral facial burns affecting nose, lips, mouth, or throat .
- Altered level of consciousness at any time after the incident and including confusion.
- Symptoms of respiratory distress including a sense of suffocation, choking, breathlessness, and wheezing or discomfort affecting the eyes or throat, including irritation of the mucosal membranes.
Key exclusion criteria (6 listed)
- Burn injury > 24 hours.
- History of pulmonary diseases.
- Pregnancy or breast feeding.
- History of allergy to heparin or HIT.
- History or laboratory evidence of coagulopathy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HeparinHeparin sodium (Generic, 5000 IU/ml ampoules) | Drug | Group A (Nebulized Heparin) |
| Normal SalineAlso: Saline0.9% sodium chloride solution (normal saline) | Other | Group B (Nebulized Saline) |
Primary outcome
VFDs
Time frame: 28 days
Number of days free of mechanical ventilation
5 secondary outcomes
ICU-free days
Time frame: 28 days
Duration of mechanical ventilation
Time frame: 28 days
Mortality
Time frame: 28 days
Side effects
Time frame: 28 days
P/F ratio
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Background: PubMed 3202424Murray JF, Matthay MA, Luce JM, Flick MR. An expanded definition of the adult respiratory distress syndrome. Am Rev Respir Dis. 1988 Sep;138(3):720-3. doi: 10.1164/ajrccm/138.3.720. No abstract available.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sameh M Hakim, MD principal investigator
Ain Shams University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Heparin and Normal Saline in people with Smoke Inhalation Injury and Acute Lung Injury, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VFDs (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05886998, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.