Health TrialsbyHealthPanel

A Study of Venoarterial ECMO vs Off-Pump Bilateral Orthotopic Lung Transplantation

ConditionLung Transplant
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

The purpose of this research study is to compare the technique of performing bilateral lung transplantation off-pump vs venoarterial ECMO (VA ECMO). The goal of the trial is to determine which technique has lower rates of primary graft dysfunction.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Bilateral Lung Transplantation (LTx) recipients.

Mean pulmonary artery pressure < or = 35 mmHg.

Eligible for off-pump or VA ECMO based on the judgement of the attending surgeon.

Disqualifiers

Single lung transplant

Multiorgan transplant.

Donor after cardiac death (DCD).

Re-transplant.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Off-pump lung transplantation

    Procedure/Surgery

    General anesthesia, intubation with double lumen tube, thoracotomies or clamshell incision, pneumonectomy starting by the less perfused lung in the scan, stump preparation, lung implantation, reperfusion, gradual release of the pulmonary artery clamp, deairing, ventilation of the 1st implanted lung. The process is repeated at the contralateral side. Ventilation of both lungs, chest closure.

  • Venoarterial ECMO lung transplantation

    Procedure/Surgery

    General anesthesia, intubation with double lumen tube, thoracotomies or clamshell incision, heparin, peripheral or central venoarterial ECMO cannulation, first pneumonectomy, stump preparation, lung implantation, reperfusion, release of the pulmonary artery clamp, deairing, ventilation of the 1st implanted lung. The process is repeated at the contralateral side. Ventilation of both lungs, ECMO decannulation, chest closure.

Treatment groups

228 Participants
are divided into 2 treatment groups
Group A: Off-Pump Bilateral Lung TransplantationActive comparator 1 intervention
Group B: Venoarterial Extra Corporeal Membrane Oxygenation (VA ECMO) Bilateral Lung TransplantationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Primary Lung Graft Dysfunction (PGD) grade 3

Rate of PGD according to the The International Society for Heart and Lung Transplantation (ISHLT) classification

Time frame
48-72 hours
2

Mortality

Death rate of subjects following lung transplantation

Time frame
90 days
3

Primary Lung Graft Dysfunction (PGD) grade 3 and Mortality

Rate of PGD according to the The International Society for Heart and Lung Transplantation (ISHLT) classification plus the Death rate of subjects following lung transplantation

Time frame
48-72 hours and 90 days

Secondary outcomes

1

Red blood cell transfusions

Number of subjects to require red blood cell transfusions

Time frame
Intraoperative plus the first 24 hours in the ICU
2

Chest tube output

Chest tube output the first 24 hours following lung transplantation reported in cubic centimeter (cc)

Time frame
First 24 hours
3

Incidence of re-exploration for bleeding

Number of subject to require re-exploration for bleeding

Time frame
First 48 hours
4

Incidence of air emboli

Number of subjects to experience air emboli

Time frame
During VA ECMO run

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
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