The Use of Surfactant in Lung Transplantation: A Randomized Control Pilot Study
NCT ID: NCT00506532
Last Updated: 2007-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
42 participants
INTERVENTIONAL
2005-01-31
2008-12-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Interventions
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Surfactant (calfactant)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Pulmonary Edema
* Stenosis or thrombosis of pulmonary artery/vein anastomosis
16 Years
68 Years
ALL
No
Sponsors
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Rabin Medical Center
OTHER
Principal Investigators
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MordechaI R Kramer, Prof
Role: PRINCIPAL_INVESTIGATOR
Pulmonary Institute Rabin Medical Center
Locations
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Pulmonary Institute Rabin Medical Center
Petah Tikva, , Israel
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RMC063344ctil
Identifier Type: -
Identifier Source: org_study_id