Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2026-01-05 @ 5:12 PM
Study NCT ID:
NCT00506532
Status:
UNKNOWN
Last Update Posted:
2007-07-25
First Post:
2007-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of Surfactant in Lung Transplantation: A Randomized Control Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055031', 'term': 'Primary Graft Dysfunction'}], 'ancestors': [{'id': 'D015427', 'term': 'Reperfusion Injury'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013501', 'term': 'Surface-Active Agents'}, {'id': 'C117342', 'term': 'calfactant'}], 'ancestors': [{'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-07', 'completionDateStruct': {'date': '2008-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2007-07-23', 'studyFirstSubmitDate': '2007-07-15', 'studyFirstSubmitQcDate': '2007-07-23', 'lastUpdatePostDateStruct': {'date': '2007-07-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of intraoperative exogenous surfactant treatment on oxygenation and primary graft dysfunction (PGD) prevention (primary outcome)', 'timeFrame': '3 days post operation'}], 'secondaryOutcomes': [{'measure': 'Recovery-Extubation ;Seating time; Icu stay; Hospital stay; Lung function', 'timeFrame': '1 month'}]}, 'conditionsModule': {'keywords': ['Pulmonary Surfactants', 'Lung transplantation', 'Primary Graft Dysfunction'], 'conditions': ['Lung Transplantation', 'Primary Graft Dysfunction']}, 'descriptionModule': {'briefSummary': '1. Working Hypothesis:\n\n 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.\n2. Aims of the Study:\n\nThe 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.', 'detailedDescription': '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.\n\nWorking hypothesis and aims:\n\nThe 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.\n\nMethods: The trial is an open randomized controlled prospective study. Patient population: 42 patients eligible for lung transplant according to hospital criteria.\n\nStudy 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).\n\nStudy 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.\n\nExpected 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.\n\nImportance: 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '68 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Candidates for lung transplantation\n\nExclusion Criteria:\n\n* Differential diagnosis of PGD\n* Pulmonary Edema\n* Stenosis or thrombosis of pulmonary artery/vein anastomosis'}, 'identificationModule': {'nctId': 'NCT00506532', 'briefTitle': 'The Use of Surfactant in Lung Transplantation: A Randomized Control Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Rabin Medical Center'}, 'officialTitle': 'The Use of Surfactant in Lung Transplantation: A Randomized Control Pilot Study', 'orgStudyIdInfo': {'id': 'RMC063344ctil'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Surfactant (calfactant)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '49100', 'city': 'Petah Tikva', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Mordechai R kramer, prof', 'role': 'CONTACT', 'email': 'kremerm@clalit.org.il', 'phone': '972-3-9377221'}, {'name': 'Anat Amital, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'David Shitrit, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ilana Bakal', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Yael Raviv, Dr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Pulmonary Institute Rabin Medical Center', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}], 'centralContacts': [{'name': 'Mordechai R Kramer, Prof', 'role': 'CONTACT', 'email': 'kremerm@clalit.org.il', 'phone': '972-3-9377121'}, {'name': 'Anat Amital, Dr', 'role': 'CONTACT', 'email': 'anatam@clalit.org.il', 'phone': '972-3-9377140'}], 'overallOfficials': [{'name': 'MordechaI R Kramer, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pulmonary Institute Rabin Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rabin Medical Center', 'class': 'OTHER'}}}}