UMIN-ICDS Clinical Trial

Public title

Inhaled heparin for airway burn and smoke inhalation injury: a systematic review of randomized controlled trials

Acronym

AirwayBurn-Heparin RCT SR and MA

Scientific Title

Efficacy and safety of nebulized heparin for airway burn and smoke inhalation injury: a systematic review and meta-analysis of randomized controlled trials

Scientific Title:Acronym

AirwayBurn-Heparin RCT SR and MA

Region

Japan	Asia(except Japan)	North America
South America	Australia	Europe
Africa

Condition

Airway burn and smoke inhalation injury

Classification by specialty

Emergency medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate whether a treatment strategy including inhaled heparin improves ventilator-free days and other clinical outcomes without increasing safety concerns in patients with airway burn or smoke inhalation injury, compared with placebo, nebulized saline, or a control strategy without inhaled heparin. The primary analysis will include all eligible trials, with a sensitivity analysis restricted to trials in which non-heparin cointerventions are identical or equivalent between groups.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Ventilator-free days through day 28. The trial-defined number of days alive and free from mechanical ventilation during the first 28 days after randomization will be used, generally assigning zero ventilator-free days to participants who die within 28 days.

Key secondary outcomes

1) ICU length of stay; 2) all-cause mortality within 28 days after randomization; 3) PaO2/FiO2 ratio; 4) Lung Injury Score; 5) pneumonia or ventilator-associated pneumonia; and 6) major bleeding, other clinically important bleeding, adverse events leading to treatment discontinuation, and serious adverse events. Outcomes will be pooled only when their definitions and assessment times are clinically comparable; otherwise, they will be presented narratively.

Study type

Others,meta-analysis etc

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Two-arm, individually randomized, parallel-group trials with a planned 1:1 allocation ratio between an inhaled-heparin group and a comparator. Eligible participants are adults or children diagnosed with airway burn or inhalation injury after exposure to heat, smoke, or combustion products using bronchoscopy or trial-defined clinical, imaging, or laboratory criteria. The intervention is any regimen containing nebulized or aerosolized unfractionated heparin, irrespective of dose, frequency, initiation, or duration. Comparators may be placebo, nebulized saline, or standard care without inhaled heparin. No restriction will be placed on cutaneous burn, severity, mechanical ventilation, age, sex, country, language, or publication status.

Key exclusion criteria

Non-randomized or quasi-randomized studies; cluster-randomized or crossover trials; trials planning an allocation ratio other than 1:1; and animal or healthy-volunteer studies. Studies without separable arm-level data for airway burn or smoke inhalation injury; studies of COVID-19, general ARDS, pneumonia, asthma, or COPD without airway burn or smoke inhalation injury; and studies using only intravenous or subcutaneous heparin.

Target sample size

200

Name of lead principal investigator

1st name	Ryo
Middle name
Last name	Hisamune

Organization

Osaka Medical and Pharmaceutical University

Division name

Department of Emergency and Critical Care Medicine, Faculty of Medicine

Zip code

569-8686

Address

2-7 Daigaku-machi, Takatsuki, Osaka

TEL

072-683-1221

Email

ryo.hisamune@ompu.ac.jp

Name of contact person

1st name	Ryo
Middle name
Last name	Hisamune

Organization

Osaka Medical and Pharmaceutical University

Division name

Department of Emergency Medicine, Faculty of Medicine

Zip code

569-8686

Address

2-7 Daigaku-machi, Takatsuki, Osaka

TEL

072-683-1221

Homepage URL

Email

ryo.hisamune@ompu.ac.jp

Institute

Osaka Medical and Pharmaceutical University

Institute

Department

Personal name

Organization

self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

None

Address

None

Tel

072-683-1221

Email

ryo.hisamune@ompu.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

09

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

09

Month

01

Day

Date of IRB

Anticipated trial start date

2026

Year

09

Month

01

Day

Last follow-up date

2026

Year

10

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

2027

Year

03

Month

31

Day

Other related information

This review will include two-arm parallel RCTs with individual, planned 1:1 allocation. Preliminary studies are Hakim 2025 (n=88), HEPBURN/Glas 2020 (n=13), and Nguyen 2026 (n=76), totaling 177 participants; final numbers will follow the updated search. Eligible trials must compare a strategy containing inhaled unfractionated heparin with placebo, nebulized saline, or a control without inhaled heparin. Differences in non-heparin cointerventions will not cause exclusion but will be recorded and considered for clinical heterogeneity and certainty of evidence. Dose-comparison trials in which both groups receive inhaled heparin will be excluded. A sensitivity analysis limited to trials with identical or equivalent non-heparin cointerventions will assess effects more attributable to inhaled heparin. MEDLINE, Embase, and CENTRAL will be searched from inception without language restrictions, with citation tracking and author contact. Studies reported as randomized but lacking allocation details will be provisionally eligible and queried; RoB 2 will be applied unless an explicit quasi-random method is identified. Discrepancies in sample size, groups, interventions, or outcomes across registries and reports will be reconciled by trial family. Two human reviewers will independently decide selection, extraction, RoB 2, and GRADE. Mortality will be pooled as risk ratios using a REML random-effects model. HKSJ 95% confidence intervals will be used when k>2 and tau-squared>0; otherwise, Wald intervals will be used. A common-effect model will be a sensitivity analysis. Trials will not be excluded solely for heterogeneity or significance. SAE counts require explicit definitions and systematic arm-level collection; statements such as "no adverse events" will not be treated as zero. All stages will be performed in Clarion Evidence Studio. AI will not count as an independent reviewer; source anchors, decision rationales, change histories, and audit exports will be retained.

Registered date

2026

Year

08

Month

26

Day

Last modified on

2026

Year

08

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071785