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Extracorporeal Support
Intraoperative ECMO Strategies for Lung Transplant
N/A
Waitlist Available
Led By Basil Nasir, MD
Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial is testing whether it's better to have cardiopulmonary support during a lung transplant only when needed (on demand), or to have it routinely.
Who is the study for?
This trial is for patients undergoing lung transplant surgery within a 6-month period. It's not suitable for those who can't consent, are having multiple organ transplants, or must have intraoperative support due to severe pulmonary hypertension, significant heart dysfunction, or retransplantation.Check my eligibility
What is being tested?
The study compares two approaches during lung transplant surgery: 'Routine ECMO' where all patients receive cardiopulmonary support and 'On demand ECMO' where support is provided only if serious heart or oxygen issues arise during the operation.See study design
What are the potential side effects?
Potential side effects may include complications from using the ECMO machine such as bleeding, blood clots, infection risk increase and possible damage to organs like kidneys or brain due to reduced blood flow.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Study recruitment rate
Secondary outcome measures
Incidence of all-cause mortality at 30 days, 90 days, and one year
Incidence of an Early major postoperative neurologic complication (EMPNC): This includes stroke, severe encephalopathy, and severe seizures diagnosed within 14 days after surgery.
Incidence of postoperative stroke / cerebrovascular accident
+3 moreOther outcome measures
Duration of mechanical ventilation in hours
Forced expiratory volume at 1 second (FEV1) at 1 year
Incidence and grade of primary graft dysfunction (PGD) at 0, 24, 48, and 72 hours
+10 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: On demand ECMO (study group)Experimental Treatment1 Intervention
Group II: Routine ECMO (control group)Active Control1 Intervention
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Who is running the clinical trial?
Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
366 Previous Clinical Trials
129,608 Total Patients Enrolled
3 Trials studying Postoperative Complications
1,017 Patients Enrolled for Postoperative Complications
Basil Nasir, MDPrincipal InvestigatorCentre hospitalier de l'Université de Montréal (CHUM)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had an organ transplant before.I am scheduled for a lung transplant within the next 6 months.I need support during my lung transplant surgery as doing it without support is unsafe.I have severe pulmonary hypertension.I cannot or do not want to give consent for this study.I have had a transplant involving multiple organs.I have had surgery or stenting for severe heart artery blockages.
Research Study Groups:
This trial has the following groups:- Group 1: On demand ECMO (study group)
- Group 2: Routine ECMO (control group)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the trial currently have open enrollment?
"Indeed, the information available on clinicaltrials.gov supports that this trial is actively looking for participants. The posting first went live on September 15th 2022 and has been updated as recently as October 24th of this year. 26 patients need to be sourced from a single medical centre in order to meet their recruitment needs."
Answered by AI
How extensive is the participant pool of this clinical experiment?
"Affirmative. Perusing the details on clinicaltrials.gov, one can conclude that this research program is actively recruiting test subjects. The trial was initially announced on September 15th 2022 and has been amended as recently as October 24th 2022; with a goal of enrolling 26 people across 1 location."
Answered by AI
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