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The Use of Surfactant in Lung Transplantation: A Randomized Control Pilot Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by Rabin Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT00506532
First received: July 15, 2007
Last updated: July 23, 2007
Last verified: July 2007

July 15, 2007
July 23, 2007
January 2005
Not Provided
Effect of intraoperative exogenous surfactant treatment on oxygenation and primary graft dysfunction (PGD) prevention (primary outcome) [ Time Frame: 3 days post operation ]
Same as current
Complete list of historical versions of study NCT00506532 on ClinicalTrials.gov Archive Site
Recovery-Extubation ;Seating time; Icu stay; Hospital stay; Lung function [ Time Frame: 1 month ]
Same as current
Not Provided
Not Provided
 
The Use of Surfactant in Lung Transplantation: A Randomized Control Pilot Study
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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Lung Transplantation
  • Primary Graft Dysfunction
Drug: Surfactant (calfactant)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
42
December 2008
Not Provided

Inclusion Criteria:

  • Candidates for lung transplantation

Exclusion Criteria:

  • Differential diagnosis of PGD
  • Pulmonary Edema
  • Stenosis or thrombosis of pulmonary artery/vein anastomosis
Both
16 Years to 68 Years
No
Contact: Mordechai R Kramer, Prof 972-3-9377121 kremerm@clalit.org.il
Contact: Anat Amital, Dr 972-3-9377140 anatam@clalit.org.il
Israel
 
NCT00506532
RMC063344ctil
Not Provided
Not Provided
Rabin Medical Center
Not Provided
Principal Investigator: MordechaI R Kramer, Prof Pulmonary Institute Rabin Medical Center
Principal Investigator: Mordechai R Kramer, Prof Pulmonary Institute Rabin Medical Center
Rabin Medical Center
July 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP