A Phase 2/3 interventional study of Surfactant (calfactant) in Lung Transplantation and Primary Graft Dysfunction, sponsored by Rabin Medical Center. Status unknown at 1 site in Israel. Open to participants aged 16 Years to 68 Years. Per ClinicalTrials.gov, last updated 2007-07-25.
Sponsored by Rabin Medical Center · Phase 2/3, Interventional, and Prevention
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.
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.
26 studies on the registry are indexed under Primary Graft Dysfunction; 4 are open to participants now.
This study's planned enrollment of 42 is below the median of 47 across 11 interventional studies indexed under Primary Graft Dysfunction.
Browse Primary Graft Dysfunction studies →Rabin Medical Center is the lead sponsor of 393 studies on the registry; 30 are open to participants now.
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Exclusion Criteria:
Effect of intraoperative exogenous surfactant treatment on oxygenation and primary graft dysfunction (PGD) prevention (primary outcome)
Time frame: 3 days post operation
Recovery-Extubation ;Seating time; Icu stay; Hospital stay; Lung function
Time frame: 1 month
This study is status unknown, as verified in Jul 2007. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Calfactant