Cystic FibrosisRetroLUTXNCT03919604
ECMO for Lung Transplantation in Cystic Fibrosis Patients
An observational study of Cystic Fibrosis, run by Policlinico Hospital at 1 site in Italy.
Trial summary
Cystic fibrosis (CF) is the most common genetically inherited disease in the Caucasian population. Bilateral lung transplantation (LUTX) is a viable option for these patients. Frequently, the surgical operation of LUTX is complicated by hemodynamic instability, intractable hypoxia and respiratory acidosis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Extracorporeal Life Support
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2013to 31 Dec 2018
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Any patient with CF undergoing LUTX at Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico during the study period
Who may be able to join
- CF
- undergoing LUTX
Who cannot join
- single lung transplantation
- re-transplantation
- missing medical records.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Extracorporeal Membrane Oxygenation for Lung Transplantation in Cystic Fibrosis Patients: Predictors and Impact on Outcome
Cystic fibrosis (CF) is the most common genetically inherited disease in the Caucasian population. Bilateral lung transplantation (LUTX) is a viable option for these patients.
Frequently, the surgical operation of LUTX is complicated by hemodynamic instability, intractable hypoxia and respiratory acidosis. For these reasons, Intraoperative extracorporeal life support - ECLS- is required. Data on predictors of use of intraoperative ECLS in CF patients undergoing LUTX is scarce. Aim of this retrospective observational study was 1) to find possible risk factors at the time of enlistment associated with the intraoperative use of ECLS and 2) to compare the outcomes of CF patients treated with ECLS during LUTX or not.
Read the detailed description
Cystic fibrosis (CF) is the most common genetically inherited disease in the Caucasian population and damages multiple organ systems (i.e., upper and lower respiratory tract, pancreas, liver). Respiratory manifestations include reduction of mucus clearance, chronic pulmonary infections and bronchiectasis, causing progressive respiratory failure that is the primary cause of death in CF patients. Moreover, advanced CF is complicated by pulmonary hypertension, right ventricular hypertrophy and right heart failure. Bilateral lung transplantation (LUTX) is a viable option for these patients, providing a significant survival benefit as compared to no-LuTX.
Frequently, the surgical operation of LUTX is complicated by acute heart failure (due to sequential pulmonary artery cross-clamping and/or hemodynamic instability), severe intractable hypoxia and respiratory acidosis. For these reasons, extracorporeal life support - ECLS - (either in the form of cardiopulmonary bypass -CBP- or extracorporeal membrane oxygenation -ECMO) is frequently required.
To now, literature data on predictors of use of intraoperative ECLS in CF patients undergoing LUTX is scarce. Notably, the use of ECLS during LUTX has been associated with a higher risk of primary graft dysfunction (PGD). Moreover, knowing that a patient has a high risk for the use of ECLS may allow appropriate clinical planning of the procedure with eventual elective ECMO connection.
The investigator's Institution (Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico) is an Italian tertiary referral center for CF and LUTX, as well as for respiratory failure and ECMO support. Aim of this retrospective observational study was 1) to find possible risk factors at the time of enlistment associated with the intraoperative use of ECLS and 2) to compare the outcomes of CF patients treated with ECLS during LUTX or not.
- Conditions
- Cystic Fibrosis
- Being tested
- Extracorporeal Life Support
- Keywords
- cystic fibrosis, lung transplantation, extracorporeal membrane oxygenation
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal Life SupportProcedure or surgery
Also called Extracorporeal membrane oxygenation, Cardiopulmonary Bypass
Any extracorporeal blood treatment technique for respiratory and/or cardiac support
| Study group | Role | What they receive |
|---|---|---|
| ECLS group | Patients with CF undergoing LUTX. Need for intraoperative extracorporeal life support Receives: Procedure: Extracorporeal Life Support | |
| Non-ECLS group | Patients with CF undergoing LUTX. No need for intraoperative extracorporeal life support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative use of blood components
Intraoperative use of: 1) packed red blood cells used (units); 2) fresh frozen plasma (units); 3) pooled platelets (units)
Measured: Jan 2013 Dec 2018
Length of mechanical ventilation
Length of invasive mechanical ventilation (days)
Measured: Jan 2013 Dec 2018
Length of intensive care unit (ICU) stay
Intensive care unit stay (days)
Measured: Jan 2013 Dec 2018
Length of Hospital stay
Length of hospital stay (days)
Measured: Jan 2013 Dec 2018
Primary graft dysfunction
Primary graft dysfunction at 72 hours from re-perfusion of grafts (classes)
Measured: Jan 2013 Dec 2018
Secondary outcomes (1)
Survival
survival at 31st March 2019.
Measured: Jan 2013 Dec 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2019
- Study start1 Jan 2013
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Policlinico Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giacomo Grasselli, Policlinico Hospital
- Investigators
- Giacomo Grasselli, Study director, Universita' di Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03919604
- Sponsor's protocol ID
- 346_2018bis
- Acronym
- RetroLUTX
- Status last verified
- Apr 2019
- First submitted
- 11 Apr 2019
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracorporeal Membrane Oxygenation for Lung Transplantation in Cystic Fibrosis Patients: Predictors and Impact on Outcome
- ClinicalTrials.gov ID
- NCT03919604
- Acronym / sponsor ID
- RetroLUTX / 346_2018bis
- Conditions
- Cystic Fibrosis
- Keywords
- cystic fibrosis, lung transplantation, extracorporeal membrane oxygenation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Policlinico HospitalUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 18 Apr 2019 (actual)
- 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.
Cystic fibrosis (CF) is the most common genetically inherited disease in the Caucasian population. Bilateral lung transplantation (LUTX) is a viable option for these patients.
Frequently, the surgical operation of LUTX is complicated by hemodynamic instability, intractable hypoxia and respiratory acidosis. For these reasons, Intraoperative extracorporeal life support - ECLS- is required. Data on predictors of use of intraoperative ECLS in CF patients undergoing LUTX is scarce. Aim of this retrospective observational study was 1) to find possible risk factors at the time of enlistment associated with the intraoperative use of ECLS and 2) to compare the outcomes of CF patients treated with ECLS during LUTX or not.
Detailed description
Cystic fibrosis (CF) is the most common genetically inherited disease in the Caucasian population and damages multiple organ systems (i.e., upper and lower respiratory tract, pancreas, liver). Respiratory manifestations include reduction of mucus clearance, chronic pulmonary infections and bronchiectasis, causing progressive respiratory failure that is the primary cause of death in CF patients. Moreover, advanced CF is complicated by pulmonary hypertension, right ventricular hypertrophy and right heart failure. Bilateral lung transplantation (LUTX) is a viable option for these patients, providing a significant survival benefit as compared to no-LuTX.
Frequently, the surgical operation of LUTX is complicated by acute heart failure (due to sequential pulmonary artery cross-clamping and/or hemodynamic instability), severe intractable hypoxia and respiratory acidosis. For these reasons, extracorporeal life support - ECLS - (either in the form of cardiopulmonary bypass -CBP- or extracorporeal membrane oxygenation -ECMO) is frequently required.
To now, literature data on predictors of use of intraoperative ECLS in CF patients undergoing LUTX is scarce. Notably, the use of ECLS during LUTX has been associated with a higher risk of primary graft dysfunction (PGD). Moreover, knowing that a patient has a high risk for the use of ECLS may allow appropriate clinical planning of the procedure with eventual elective ECMO connection.
The investigator's Institution (Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico) is an Italian tertiary referral center for CF and LUTX, as well as for respiratory failure and ECMO support. Aim of this retrospective observational study was 1) to find possible risk factors at the time of enlistment associated with the intraoperative use of ECLS and 2) to compare the outcomes of CF patients treated with ECLS during LUTX or not.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ECLS group | – | Procedure: Extracorporeal Life SupportPatients with CF undergoing LUTX. Need for intraoperative extracorporeal life support |
| Non-ECLS group | – | –Patients with CF undergoing LUTX. No need for intraoperative extracorporeal life support |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any patient with CF undergoing LUTX at Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico during the study period
Key inclusion criteria (2 listed)
- CF
- undergoing LUTX
Key exclusion criteria (3 listed)
- single lung transplantation
- re-transplantation
- missing medical records.
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 |
|---|---|---|
| Extracorporeal Life SupportAlso: Extracorporeal membrane oxygenation, Cardiopulmonary BypassAny extracorporeal blood treatment technique for respiratory and/or cardiac support | Procedure or surgery | ECLS group |
Primary outcome
Intraoperative use of blood components
Time frame: Jan 2013 Dec 2018
Intraoperative use of: 1) packed red blood cells used (units); 2) fresh frozen plasma (units); 3) pooled platelets (units)
Length of mechanical ventilation
Time frame: Jan 2013 Dec 2018
Length of invasive mechanical ventilation (days)
Length of intensive care unit (ICU) stay
Time frame: Jan 2013 Dec 2018
Intensive care unit stay (days)
Length of Hospital stay
Time frame: Jan 2013 Dec 2018
Length of hospital stay (days)
Primary graft dysfunction
Time frame: Jan 2013 Dec 2018
Primary graft dysfunction at 72 hours from re-perfusion of grafts (classes)
1 secondary outcome
Survival
Time frame: Jan 2013 Dec 2018
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
- Individual participant dataSharing planned: Undecided
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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.
Giacomo Grasselli study director
Universita' di Milano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by Policlinico Hospital at 1 site in Italy.
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 2 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: finished, as of the sponsor's last update on 18 Apr 2019. 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 Italy. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative use of blood components (time frame: Jan 2013 Dec 2018). The study lists 5 primary outcomes in all. 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 18 Apr 2019.