NCT02483702 - 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)

Bontadini A, Tazzari PL, Manfroi S, Tassi C, Conte R
Apoptosis in leucodepleted packed red blood cells. Vox Sang. 2002 Jul;83(1):35-41.
Faberowski LW, Black S, Mickle JP
Blood loss and transfusion practice in the perioperative management of craniosynostosis repair. J Neurosurg Anesthesiol. 1999 Jul;11(3):167-72.
Lee AC, Reduque LL, Luban NL, Ness PM, Anton B, Heitmiller ES
Transfusion-associated hyperkalemic cardiac arrest in pediatric patients receiving massive transfusion. Transfusion. 2014 Jan;54(1):244-54. doi: 10.1111/trf.12192. Epub 2013 Apr 15. Review.
Olson J, Talekar M, Sachdev M, Castellani W, De la Cruz N, Davis J, Liao J, George M
Potassium changes associated with blood transfusion in pediatric patients. Am J Clin Pathol. 2013 Jun;139(6):800-5. doi: 10.1309/AJCP2MP8OIIXNKXF.
Rosen NR, Weidner JG, Boldt HD, Rosen DS
Prevention of transfusion-associated graft-versus-host disease: selection of an adequate dose of gamma radiation. Transfusion. 1993 Feb;33(2):125-7.
Schroeder ML
Transfusion-associated graft-versus-host disease. Br J Haematol. 2002 May;117(2):275-87. Review.
Sharma S, Sharma P, Tyler LN
Transfusion of blood and blood products: indications and complications. Am Fam Physician. 2011 Mar 15;83(6):719-24. Review.
Vraets A, Lin Y, Callum JL
Transfusion-associated hyperkalemia. Transfus Med Rev. 2011 Jul;25(3):184-96. doi: 10.1016/j.tmrv.2011.01.006. Epub 2011 Apr 17. Review.
Weiskopf RB, Schnapp S, Rouine-Rapp K, Bostrom A, Toy P
Extracellular potassium concentrations in red blood cell suspensions after irradiation and washing. Transfusion. 2005 Aug;45(8):1295-301. Erratum in: Transfusion. 2006 Aug;46(8):1461.

The Affect of Radiated Versus Non-Irradiated Blood on Extracellular Potassium Levels in Infants Undergoing Craniosynostosis Repair

Details for clinical trial NCT02483702

Clinical trial NCT02483702 - References