What side effects are associated with this type of intervention?

The most common treatments for postoperative complications, such as ECMO, can have several side effects. These include bleeding, infection, thrombosis, and limb ischemia. Complications related to cannulation sites, such as vessel injury and hematoma formation, are also possible. Additionally, patients may experience hemolysis and complications from anticoagulation therapy, which is necessary to prevent clot formation in the ECMO circuit.

What prior FDA approvals exist?

The FDA has approved several treatments for managing postoperative complications, particularly those involving cardiopulmonary support and hemodynamic stability. Extracorporeal Membrane Oxygenation (ECMO) is a critical intervention used in cases of severe cardiac and respiratory failure, providing temporary support to patients with compromised heart and lung function. While ECMO itself is a procedure rather than a drug, related pharmacological treatments often include anticoagulants like heparin to prevent clotting during ECMO therapy. Additionally, vasopressors such as norepinephrine and vasopressin are commonly used to maintain blood pressure and ensure adequate organ perfusion in patients experiencing postoperative shock or hemodynamic instability.

What other types of research exist?

Promising novel alternatives to ECMO for managing postoperative complications include: 1) Normothermic ex-vivo lung perfusion (EVLP) using devices like the Organ Care System (OCS), which allows for lung perfusion and ventilation without the need for extended cold storage. 2) Experimental pharmacologic agents such as Prostaglandin E2 (PGE2), inhaled carbon monoxide, oxygen free radical scavengers, and phosphodiesterase-5 inhibitors (e.g., sildenafil). These agents aim to reduce lung injury and improve graft function. 3) Gene therapy approaches, such as IL-10 gene therapy, which are being investigated for their potential to modulate inflammatory responses and improve outcomes in lung transplantation.

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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 beginning from the arrival to the intensive care unit immediately after surgery, up to about 30 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether using a specific medical support only when needed during lung transplants is as effective as using it routinely. The study focuses on patients without severe heart or lung issues to see if this approach reduces complications. Recent improvements in technology have led to better outcomes in lung transplantation.

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.

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.

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 ~ beginning from the arrival to the intensive care unit immediately after surgery, up to about 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~beginning from the arrival to the intensive care unit immediately after surgery, up to about 30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and beginning from the arrival to the intensive care unit immediately after surgery, up to about 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Other study objectives

Duration of mechanical ventilation in hours

Perioperative blood product transfusion requirements

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

On demand ECMO

2022

N/A

~30

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Extracorporeal Membrane Oxygenation (ECMO) is a critical treatment for managing severe postoperative complications by providing cardiopulmonary support. ECMO works by oxygenating the blood outside the body and removing carbon dioxide, which helps maintain hemodynamic stability and adequate oxygenation in patients with compromised lung function or severe pulmonary hypertension. This is particularly important in postoperative patients who may experience severe hypoxia or hemodynamic instability, as ECMO can bridge the gap when traditional methods are insufficient, thereby improving patient outcomes and reducing the risk of severe complications.