Lung TransplantationPhase 2/3NCT00506532
The Use of Surfactant in Lung Transplantation: A Randomized Control Pilot Study
A Phase 2/3 study testing Surfactant (calfactant) in people with Lung Transplantation and Primary Graft Dysfunction, run by Rabin Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 16 to 68 years
- Conditions the study is for
- Lung Transplantation, Primary Graft Dysfunction
- What is being tested?
- Surfactant (calfactant)
- How many people
- 42 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2005to Dec 2008
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 68 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Candidates for lung transplantation
Who cannot join
- Differential diagnosis of PGD
- Pulmonary Edema
- Stenosis or thrombosis of pulmonary artery/vein anastomosis
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Pulmonary Institute Rabin Medical Center
Petah Tikva, 49100
Mordechai R kramer, prof, 972-3-9377221, kremerm@clalit.org.il
Anat Amital, Dr
About this study
- 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.
- 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.
Read the 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.
- Conditions
- Lung Transplantation, Primary Graft Dysfunction
- Being tested
- Surfactant (calfactant)
- Keywords
- Pulmonary Surfactants, Lung transplantation, Primary Graft Dysfunction
- Medical subject headings
- Primary Graft Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surfactant (calfactant)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of intraoperative exogenous surfactant treatment on oxygenation and primary graft dysfunction (PGD) prevention (primary outcome)
Measured: 3 days post operation
Secondary outcomes (1)
Recovery-Extubation ;Seating time; Icu stay; Hospital stay; Lung function
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2007 (estimated)
- Study startJan 2005
- Study completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- MordechaI R Kramer, Prof, Principal investigator, Pulmonary Institute Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00506532
- Sponsor's protocol ID
- RMC063344ctil
- Status last verified
- Jul 2007
- First submitted
- 15 Jul 2007
- Last updated
- 25 Jul 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Surfactant in Lung Transplantation: A Randomized Control Pilot Study
- ClinicalTrials.gov ID
- NCT00506532
- Acronym / sponsor ID
- RMC063344ctil
- Conditions
- Lung Transplantation, Primary Graft Dysfunction
- Keywords
- Pulmonary Surfactants, Lung transplantation, Primary Graft Dysfunction
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Jan 2005
- Study completion
- Dec 2008 (estimated)
- First posted
- 25 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- 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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 16 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Candidates for lung transplantation
Key exclusion criteria (3 listed)
- Differential diagnosis of PGD
- Pulmonary Edema
- Stenosis or thrombosis of pulmonary artery/vein anastomosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surfactant (calfactant) | Drug | – |
Primary outcome
Effect of intraoperative exogenous surfactant treatment on oxygenation and primary graft dysfunction (PGD) prevention (primary outcome)
Time frame: 3 days post operation
1 secondary outcome
Recovery-Extubation ;Seating time; Icu stay; Hospital stay; Lung function
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MordechaI R Kramer, Prof principal investigator
Pulmonary Institute Rabin Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Surfactant (calfactant) in people with Lung Transplantation and Primary Graft Dysfunction, run by Rabin Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mordechai R Kramer, Prof (972-3-9377121, kremerm@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of intraoperative exogenous surfactant treatment on oxygenation and primary graft dysfunction (PGD) prevention (primary outcome) (time frame: 3 days post operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2007; AzTrials last refreshed its copy on 7 Nov 2026.