Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00506532
Other study ID # RMC063344ctil
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received July 15, 2007
Last updated July 23, 2007
Start date January 2005
Est. completion date December 2008

Study information

Verified date July 2007
Source Rabin Medical Center
Contact Mordechai R Kramer, Prof
Phone 972-3-9377121
Email kremerm@clalit.org.il
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 42
Est. completion date December 2008
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 16 Years to 68 Years
Eligibility Inclusion Criteria:

- Candidates for lung transplantation

Exclusion Criteria:

- Differential diagnosis of PGD

- Pulmonary Edema

- Stenosis or thrombosis of pulmonary artery/vein anastomosis

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
Surfactant (calfactant)


Locations

Country Name City State
Israel Pulmonary Institute Rabin Medical Center Petach Tikva

Sponsors (1)

Lead Sponsor Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Effect of intraoperative exogenous surfactant treatment on oxygenation and primary graft dysfunction (PGD) prevention (primary outcome) 3 days post operation
Secondary Recovery-Extubation ;Seating time; Icu stay; Hospital stay; Lung function 1 month
See also
  Status Clinical Trial Phase
Completed NCT02581111 - Naloxone for Optimizing Hypoxemia Of Lung Donors Phase 2/Phase 3
Recruiting NCT02177916 - Patient Education Study to Determine Knowledge Acquisition in Patients Preparing to Undergo Lung Transplantation N/A
Not yet recruiting NCT01394835 - Safety and Efficacy of Inhaled Alpha-1 Antitrypsin in Preventing Bronchiolitis Obliterable Syndrome in Lung Transplant Recipients Phase 2
Not yet recruiting NCT01162148 - Pulmonary Rehabilitation and Inspiratory Muscle Training (IMT) for Patients Following Lung Transplantation N/A
Completed NCT01204970 - Confocal Laser Micro-endoscopy in Chronic Obstructive Pulmonary Disease (COPD) and Lung Transplant Recipients N/A
Active, not recruiting NCT00980967 - Predictive Factors for Chronic Rejection in Lung Transplant Recipients: COLT Study N/A
Completed NCT00531921 - Effects of Donor and Recipient Genetic Expression on Heart, Lung, Liver, or Kidney Transplant Survival N/A
Recruiting NCT00163696 - Multi Breath Nitrogen Washout (MBNW) as a Measure of Small Airway Function in Patients With Respiratory Disease N/A
Completed NCT00177684 - Pharmacokinetic Profiles of Inhaled Lipid Complex Amphotericin B (Abelcet ®) Phase 3
Completed NCT00163891 - Comparison of Two Chest Physiotherapy Protocols in Lung Transplant Recipients N/A
Completed NCT03668483 - Relation Between Muscle Strength With Exercise Capacity and Dyspnea in LTx N/A
Not yet recruiting NCT02855372 - Impact of the Age Difference Between the Donor and Recipient on the Morbidity and Mortality After Lung Transplantation. Study on a National Multicenter Cohort (COLT) N/A
Completed NCT01212406 - Vitamin D in Bronchiolitis Obliterans Syndrome Phase 4
Completed NCT01211509 - Montelukast in Bronchiolitis Obliterans Syndrome Phase 4
Not yet recruiting NCT00808600 - Empowerment of Lung and Heart-lung Transplant Patients N/A
Completed NCT00553397 - Live Lung Donor Retrospective Study N/A
Completed NCT00402805 - Improving the Humoral Response to Influenza Vaccine in Lung Transplant Recipients by an Intradermal Strategy Phase 4
Completed NCT00701922 - Surveillance Study of Viral Infections Following Lung Transplantation N/A
Terminated NCT00235651 - Abelcet Radiotagging Protocol: Inhaled Lipid Complex Abelcet® in Lung Transplant Recipients Phase 3
Active, not recruiting NCT02936505 - Clinical Study Evaluating Two Treatment Protocols for Immunosuppressive Drugs. Looking at 3-year Incidence of CLAD. N/A