Lung Transplantation Clinical Trial
Official title:
The Use of Surfactant in Lung Transplantation: A Randomized Control Pilot Study
1. Working Hypothesis:
The purpose of the trial is to study the effect of exogenous calf surfactant
(calfactant) on the prevention of primary graft failure due to ischemic-reperfusion
lung injury in lung transplant patients.
2. Aims of the Study:
The purpose of the trial is to study the effect of exogenous calf surfactant (calfactant) on
the prevention of primary graft failure due to ischemic-reperfusion lung injury in lung
transplant patients.
Background: Lung transplantation induces surfactant dysfunction that may be a contributing
factor for primary graft dysfunction (PGD) and graft failure. Animal studies and limited
human reports suggest that surfactant administration may prevent primary graft dysfunction.
Working hypothesis and aims:
The purpose of the trial is to study the effect of exogenous calf surfactant (calfactant) on
the prevention of primary graft failure due to ischemic-reperfusion lung injury in lung
transplant patients.
Methods: The trial is an open randomized controlled prospective study. Patient population:
42 patients eligible for lung transplant according to hospital criteria.
Study medication: Calfactant intratracheal suspension -an extract of natural surfactant from
calf lungs, which includes phospholipids, neutral lipids and surfactant-associated proteins
B and C (SP-B and SP-C).
Study design: Patients randomized to receive calfactant will have the drug administered
through a fiberoptic bronchoscope distributing the drug evenly across the lung immediately
after connection. The other patient will not have any administration to avoid any excessive
flushing. When 2 lungs will be used from the same donor for 2 recipients one patient
receiving one lung will be treated with calfactant while the other patient receiving the
other lung will not be treated and serve as the control. Otherwise lungs will be treated
with surfactant in every other case.
Expected results: We expect surfactant instillation during lung transplantation to improve
oxygenation, prevent primary graft dysfunction, make intubation time shorter and to enhance
early post transplantation recovery. In a pilot study that we already performed results are
encouraging.
Importance: PGD could cause substantial morbidity and mortality among transplanted patients.
In a pilot study we already found that surfactant instillation during lung transplantation
improves oxygenation, prevents primary graft dysfunction, shortens intubation time and ICU
stay. We believe that surfactant treatment enhances early post transplantation recovery, and
may also be cost effective by shortening expensive ICU stay.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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