Temperature-controlled heart preservation system vs ice for primary graft dysfunction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The PROTECT-PGD Pilot is a multicenter, randomized, blinded feasibility trial that compares a novel temperature-controlled heart preservation system to standard ice storage. It aims to see if the Xo Port system can lower the rate of severe primary graft dysfunction within 24 hours after transplant and improve composite efficacy endpoints. The study also checks whether the trial procedures can be carried out as planned and if any protocol deviations occur. Participants will be followed for 90 days with questionnaires and blood tests aligned to standard post-transplant care. If feasibility is demonstrated, participants may be included in a subsequent full-scale trial.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Recipient: Adult (\>17 years old)
* Donor: Donation after brain death acceptable for transplant as determined by a procuring physician unaware of randomization sequence at the time of acceptance

Exclusion Criteria:

* Recipient: Multi-organ transplant recipients; Participating in an interventional study.
* Donor: Donation after cardiac death; Use of organ care system

Where it's running

• University Health Network
  Toronto, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Yasbanoo Moayedi, MD — University Health Network, Toronto
• Study coordinator: Judy Sleek, BSc.
• Email: judy.sleek@uhn.ca
• Phone: 437-676-2974

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• CCR5 immune blockade to prevent primary graft dysfunction after lung transplant

  This trial will test whether the drug Maraviroc can prevent primary graft dysfunction in adults undergoing bilateral lung transplantation who have a PGD risk score greater than 50%.

  Recruiting Phase 2 University of California, San Francisco · San Francisco, California · NCT06853223

• Analyzing risk factors for lung transplant complications

  This study is trying to see if certain chemicals in the blood can help predict the risk of serious complications after lung transplants.

  Recruiting University of Pennsylvania · Philadelphia, Pennsylvania · NCT00552357

• Improving Sleep for Older Adults in the Emergency Department

  This project tests whether wearing a Fitbit overnight can help understand and improve sleep for adults 70 and older in the emergency department who are likely to be admitted.

  Recruiting at 2 sites University Health Network, Toronto · Toronto, Ontario and 1 other locations · NCT07928141

• Can miRNA-371a-3p tell us which small testicular masses need surgery or can be watched?

  This study tests whether the miRNA-371a-3p biomarker can help decide if small testicular masses (≤2 cm) are cancer and should be treated with surgery or followed with surveillance.

  Recruiting University Health Network, Toronto · Toronto, Ontario · NCT07852871

• Effects of excitatory and inhibitory LIFUS of GPi in Parkinson’s patients without DBS

  This study tests two deep-brain focused ultrasound patterns on people with Parkinson’s to see if they change task performance and tremor, compared with a sham stimulation.

  Recruiting University Health Network, Toronto · Toronto, Ontario · NCT07846007

• Co-Adaptation of a Digital Pain Program for Canadian Veterans

  We’re testing whether a self-guided digital pain management program, delivered through the Manage My Pain app, is acceptable and useful for Canadian Veterans with chronic pain.

  Recruiting University Health Network, Toronto · Toronto, Ontario · NCT07818980

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.