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.

Study Overview

• Status: Unknown
• Conditions: Lung Transplantation; Primary Graft Dysfunction
• Intervention / Treatment: Drug: Surfactant (calfactant)

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
• Enrollment (Anticipated): 42
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Mordechai R Kramer, Prof; Phone Number: 972-3-9377121; Email: kremerm@clalit.org.il
• Study Contact Backup: Name: Anat Amital, Dr; Phone Number: 972-3-9377140; Email: anatam@clalit.org.il

Study Locations

• Israel
  • Petach Tikva, Israel, 49100
    • Recruiting
    • Pulmonary Institute Rabin Medical Center
    • Contact: Mordechai R kramer, prof; Phone Number: 972-3-9377221; Email: kremerm@clalit.org.il
    • Sub-Investigator: Anat Amital, Dr
    • Sub-Investigator: David Shitrit, Dr
    • Sub-Investigator: Ilana Bakal
    • Sub-Investigator: Yael Raviv, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Candidates for lung transplantation

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Effect of intraoperative exogenous surfactant treatment on oxygenation and primary graft dysfunction (PGD) prevention (primary outcome)	3 days post operation

Secondary Outcome Measures

Outcome Measure	Time Frame
Recovery-Extubation ;Seating time; Icu stay; Hospital stay; Lung function	1 month

Collaborators and Investigators

• Sponsor: Rabin Medical Center
• Investigators: Principal Investigator: MordechaI R Kramer, Prof, Pulmonary Institute Rabin Medical Center

Study record dates

Study Major Dates

• Study Start: January 1, 2005
• Study Completion (Anticipated): December 1, 2008

Study Registration Dates

• First Submitted: July 15, 2007
• First Submitted That Met QC Criteria: July 23, 2007
• First Posted (Estimate): July 25, 2007

Study Record Updates

• Last Update Posted (Estimate): July 25, 2007
• Last Update Submitted That Met QC Criteria: July 23, 2007
• Last Verified: July 1, 2007

More Information

Terms related to this study

• Keywords: Lung transplantation; Primary Graft Dysfunction; Pulmonary Surfactants
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Postoperative Complications; Reperfusion Injury; Primary Graft Dysfunction; Respiratory System Agents; Pulmonary Surfactants; Calfactant
• Other Study ID Numbers: RMC063344ctil