NCT02631174 - 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)

Avidan MS, Levy JH, van Aken H, Feneck RO, Latimer RD, Ott E, Martin E, Birnbaum DE, Bonfiglio LJ, Kajdasz DK, Despotis GJ
Recombinant human antithrombin III restores heparin responsiveness and decreases activation of coagulation in heparin-resistant patients during cardiopulmonary bypass. J Thorac Cardiovasc Surg. 2005 Jul;130(1):107-13.
D'Argenio DZ
Optimal sampling times for pharmacokinetic experiments. J Pharmacokinet Biopharm. 1981 Dec;9(6):739-56.
Esmon CT
The interactions between inflammation and coagulation. Br J Haematol. 2005 Nov;131(4):417-30. Review.
Guzzetta NA, Bajaj T, Fazlollah T, Szlam F, Wilson E, Kaiser A, Tosone SR, Miller BE
A comparison of heparin management strategies in infants undergoing cardiopulmonary bypass. Anesth Analg. 2008 Feb;106(2):419-25, table of contents. doi: 10.1213/01.ane.0000297290.03501.db.

Evaluation Of The Pharmacokinetics Of Antithrombin III In Neonates And Infants Undergoing CPB And ECMO Support

Clinical trial NCT02631174 - References