Ignite Creation Date:
2024-05-05 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00506532
Status:
UNKNOWN
Last Update Posted:
2007-07-25
First Post:
2007-07-15
Brief Title:
The Use of Surfactant in Lung Transplantation A Randomized Control Pilot Study
Sponsor:
Rabin Medical Center
Organization:
Rabin Medical Center
Study Overview
Official Title:
The Use of Surfactant in Lung Transplantation A Randomized Control Pilot Study
Status:
UNKNOWN
Status Verified Date:
2007-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None