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Not Yet Recruiting NCT05664204

Veno-arterial ExtraCorporeal Membrane Oxygenation to Reduce Morbidity and Mortality Following Lung TransPlant

Conditions: The Number of Ventilator-free Days in the 28 Days Following LT

Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 200
Sponsor: Assistance Publique - Hôpitaux de Paris

Location: France

Summary

In patients undergoing lung transplantation (LT), the investigators hypothesize that a "systematic" intraoperative ECMO strategy would reduce the need for invasive mechanical ventilation in the first 28 days without increasing adverse events, as compared to an "on-demand" intraoperative ECMO strategy.To date, LT remains a highly hazardous procedure. Even if the surgical procedure is well established, the intraoperative support is not, and most intra-operative ECMO decisions rely on local protocols, anesthesiologists' habits, and surgeons' preference.The efficacy of applying a "systematic" strategy on reducing the occurrence of severe primary graft dysfunction and thus mechanical ventilation in the 28 days following LT, without increasing mortality or morbidity, would support future guidelines on the use of ECMO in the intraoperative period of LT for obstructive and restrictive lung diseases.

Eligibility Criteria

Inclusion Criteria:Age >18 years Assessed for bilateral sequential lung transplantation for obstructive or restrictive lung disease Affiliation to the French social security Written informed consentExclusion Criteria:Preoperative severe pulmonary hypertension with hemodynamic collapse (severe dysfunction of the right ventricule - mPAP>30mmHg; Pulmonary vascular resistance>600 dyn.s.cm-5, and/or a ratio of mPAP/MAP above 50% with RV fractional area change <35%, RV ejection fraction< 20%, and/or RV myocardial performance index<0.50)LT for primary pulmonary hypertensionLT for cystic fibrosis and graft-vs-host diseaseRe-do LTCombined multi-organ transplantationActive malignancyPregnancy, breastfeedingPatients under guardianship (tutelle, curatelle, sauvegarde de justice)

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Source: ClinicalTrials.gov (NCT05664204). StuddyBuddy aggregates publicly available trial information.