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

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ClinicalTrials.gov Identifier: NCT00506532
Recruitment Status : Unknown
Verified July 2007 by Rabin Medical Center.
Recruitment status was:  Recruiting
First Posted : July 25, 2007
Last Update Posted : July 25, 2007
Sponsor:
Information provided by:
Rabin Medical Center

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.


Condition or disease Intervention/treatment Phase
Lung Transplantation Primary Graft Dysfunction Drug: Surfactant (calfactant) Phase 2 Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Use of Surfactant in Lung Transplantation: A Randomized Control Pilot Study
Study Start Date : January 2005
Estimated Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Effect of intraoperative exogenous surfactant treatment on oxygenation and primary graft dysfunction (PGD) prevention (primary outcome) [ Time Frame: 3 days post operation ]

Secondary Outcome Measures :
  1. Recovery-Extubation ;Seating time; Icu stay; Hospital stay; Lung function [ Time Frame: 1 month ]


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Ages Eligible for Study:   16 Years to 68 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Candidates for lung transplantation

Exclusion Criteria:

  • Differential diagnosis of PGD
  • Pulmonary Edema
  • Stenosis or thrombosis of pulmonary artery/vein anastomosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00506532


Contacts
Contact: Mordechai R Kramer, Prof 972-3-9377121 kremerm@clalit.org.il
Contact: Anat Amital, Dr 972-3-9377140 anatam@clalit.org.il

Locations
Israel
Pulmonary Institute Rabin Medical Center Recruiting
Petach Tikva, Israel, 49100
Contact: Mordechai R kramer, prof    972-3-9377221    kremerm@clalit.org.il   
Sub-Investigator: Anat Amital, Dr         
Sub-Investigator: David Shitrit, Dr         
Sub-Investigator: Ilana Bakal         
Sub-Investigator: Yael Raviv, Dr         
Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: MordechaI R Kramer, Prof Pulmonary Institute Rabin Medical Center

ClinicalTrials.gov Identifier: NCT00506532     History of Changes
Other Study ID Numbers: RMC063344ctil
First Posted: July 25, 2007    Key Record Dates
Last Update Posted: July 25, 2007
Last Verified: July 2007

Keywords provided by Rabin Medical Center:
Pulmonary Surfactants
Lung transplantation
Primary Graft Dysfunction

Additional relevant MeSH terms:
Primary Graft Dysfunction
Reperfusion Injury
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Pathologic Processes
Pulmonary Surfactants
Calfactant
Respiratory System Agents