Precise Cooler for Donor Heart Transport
ConditionHeart Transplantation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorCedars-Sinai Medical Center
About this trial
The investigators are doing this study to compare approaches to cold storage of donor hearts during transportation. The adjustable temperature RYOBI cooler should allow precise temperature control while reducing environmental waste and providing a cost savings benefit when compared to the commercially available, FDA-approved Paragonix SherpaPak device.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Individuals 18 years old or older are included.
Individuals undergoing isolated heart transplantation are included.
Disqualifiers
Any records flagged "break the glass" or "research opt out."
Any patients undergoing multi-organ transplantation.
Trial design
Design model
Parallel
Treatments tested in this trial
Organ transport using SherpaPak
DeviceParagonix SherpaPak
Ryobi cooler for Organ Transport
DeviceThis is a temperature-controlled cooler without a gel or ice
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Organ transport using Standard of Care Paragonix SherpaPakActive comparator 1 intervention
Group B: Organ transport using the RYOBI cooler.Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of primary graft dysfunction
compare the incidence of primary graft dysfunction between patients randomized to donor heart preservation using the adjustable temperature RYOBI cooler (Model # Pi1824QBT) (n = 40) versus the Paragonix SherpaPak (n = 40) in cases where the anticipated total ischemic time for the graft is between 120 and 240 minutes.
Time frame
From Randomization to 30 days after heart transplantationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: