NCT05886998

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2023

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 2, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2024

Completed
Last Updated

December 12, 2024

Status Verified

July 1, 2024

Enrollment Period

1 year

First QC Date

May 22, 2023

Last Update Submit

December 9, 2024

Conditions

Smoke Inhalation InjuryAcute Lung Injury

Keywords

Smoke Inhalation InjuryAcute Lung InjuryHeparin

Outcome Measures

Primary Outcomes (1)

  • VFDs

    Number of days free of mechanical ventilation

    28 days

Secondary Outcomes (5)

  • ICU-free days

    28 days

  • Duration of mechanical ventilation

    28 days

  • Mortality

    28 days

  • Side effects

    28 days

  • P/F ratio

    14 days

Study Arms (2)

Group A (Nebulized Heparin)

EXPERIMENTAL

Heparin is nebulized via endotracheal tube

Drug: Heparin

Group B (Nebulized Saline)

PLACEBO COMPARATOR

Normal saline is nebulized via endotracheal tube

Other: Normal Saline

Interventions

HeparinDRUG

Heparin sodium (Generic, 5000 IU/ml ampoules)

Group A (Nebulized Heparin)
Normal SalineOTHER

0.9% sodium chloride solution (normal saline)

Also known as: Saline
Group B (Nebulized Saline)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. 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.
  • 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.
  • \. 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.
  • +1 more criteria

You may not qualify if:

  • 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. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University Hospitals

Cairo, Cairo Governorate, 11517, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 3202424BACKGROUND

MeSH Terms

Conditions

Smoke Inhalation InjuryAcute Lung Injury

Interventions

HeparinSaline SolutionSodium Chloride

Condition Hierarchy (Ancestors)

Burns, InhalationBurnsWounds and InjuriesLung InjuryLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydratesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Sameh M Hakim, MD

    Ain Shams University Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 22, 2023

First Posted

June 2, 2023

Study Start

June 1, 2023

Primary Completion

June 3, 2024

Study Completion

June 3, 2024

Last Updated

December 12, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)