Tokyo, Sept. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062697) titled 'Inhaled heparin for airway burn and smoke inhalation injury: a systematic review of randomized controlled trials' on Sept. 1.

Study Type: Others,meta-analysis etc

Primary Sponsor: Institute - Osaka Medical and Pharmaceutical University

Condition: Condition - Airway burn and smoke inhalation injury Classification by malignancy - Others Genomic information - NO

Objective: 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

Eligibility: 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 Size - 200

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 09 Month 01 Day Anticipated trial start date - 2026 Year 09 Month 01 Day Last follow-up date - 2026 Year 10 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071785

Disclaimer: Curated by HT Syndication.