NCT04626284 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Barnard CN
The operation. A human cardiac transplant: an interim report of a successful operation performed at Groote Schuur Hospital, Cape Town. S Afr Med J. 1967 Dec 30;41(48):1271-4. No abstract available.
Chew HC, Iyer A, Connellan M, Scheuer S, Villanueva J, Gao L, Hicks M, Harkness M, Soto C, Dinale A, Nair P, Watson A, Granger E, Jansz P, Muthiah K, Jabbour A, Kotlyar E, Keogh A, Hayward C, Graham R, Spratt P, Macdonald P, Dhital K
Outcomes of Donation
Dhital KK, Chew HC, Macdonald PS
Donation after circulatory death heart transplantation. Curr Opin Organ Transplant. 2017 Jun;22(3):189-197. doi: 10.1097/MOT.0000000000000419.
Messer S, Page A, Colah S, Axell R, Parizkova B, Tsui S, Large S
Human heart transplantation from donation after circulatory-determined death donors using normothermic regional perfusion and cold storage. J Heart Lung Transplant. 2018 Jul;37(7):865-869.

Clinical Trial to Evaluate the Safety and Effectiveness of Normothermic Regional Perfusion (NRP) for Resuscitation of Hearts From Donation After Circulatory Death (DCD)

Details for clinical trial NCT04626284

Clinical trial NCT04626284 - References