The safety and efficacy of marginal donor for lung transplantation with normothermic ex-vivo lung perfusion (EVLP): a single-center prospective non-randomized controlled clinical trial

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100047167

Enrollment

Unknown

Registered

2021-06-09

Start date

2021-06-09

Completion date

Unknown

Last updated

2022-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung transplantation

Interventions

EVLP group:ex-vivo lung perfusion

control group:Nil

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Recipient: (1) Male or female patient requiring single or bilateral lung transplant; (2) 18 years of age or older; (3) Can provide informed consent. 2. Pre-EVLP Donor: (1) PaO2/FiO2 lower or equal 300 mmHg; (2) Or PaO2/FiO2 > 300 mmHg and one or more of the following: Multiple blood transfusions (more or equal to 10 units); Pulmonary edema; Donation after circulatory death; Deemed unsuitable by PI (such as pulmonary embolism, atelectasis and so on); 3. Post-EVLP: (1) Surgeon clinically satisfied; (2) Stability or improvement in PVR, compliance, and airway pressures; (3) Two delta PO2 more or equal 350 mmHg (do not have to be consecutive); (4) Or at least three of the following: One delta PO2 more or equal 350 or absolute PO2 more or equal 400 Chest x-ray finding with absence or improvement of edema/infiltrates; Compliance-static (> 35 single, > 60 double); No consolidation on palpation.

Exclusion criteria

Exclusion criteria: 1. Pre-EVLP Donor: (1) Significant active pneumonia and/or purulent secretions on bronchoscopy or as determined by investigator; (2) Significant aspiration of gastric contents within the lung; (3) Significant mechanical lung injury or trauma determined by chest x-ray, bronchoscopy, CT scan or visual inspection; (4) Active infectious disease (HIV, Hep B, Hep C, Syphilis); 2. Post-EVLP: (1) All delta PO2 s 10-15% functional deterioration of other lung functions with chest x-ray showing deterioration; (4) Positive for infectious disease (HIV, Hep B, Hep C, Syphilis and other infections).

Design outcomes

Primary

Measure	Time frame
The incidence of primary graft dysfunction occurs;	—

Secondary

Measure	Time frame
Primary graft dysfunction score;Forced expiratory volume in first second;Mortality;Complications after lung transplantation;Length of stay in ICU;Length of stay;	—

Countries

China

Contacts

Public ContactChen Chang

Shanghai Pulmonary Hospital

chenthoracic@163.com+86 13816869003

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026