NCT00396760 - 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)

Dietrich W, Busley R, Kriner M
High-dose aprotinin in cardiac surgery: is high-dose high enough? An analysis of 8281 cardiac surgical patients treated with aprotinin. Anesth Analg. 2006 Nov;103(5):1074-81.
Diprose P, Herbertson MJ, O'Shaughnessy D, Deakin CD, Gill RS
Reducing allogeneic transfusion in cardiac surgery: a randomized double-blind placebo-controlled trial of antifibrinolytic therapies used in addition to intra-operative cell salvage. Br J Anaesth. 2005 Mar;94(3):271-8. Epub 2004 Dec 10.
Henry DA, Moxey AJ, Carless PA, O'Connell D, McClelland B, Henderson KM, Sly K, Laupacis A, Fergusson D
Anti-fibrinolytic use for minimising perioperative allogeneic blood transfusion. Cochrane Database Syst Rev. 2001;(1):CD001886. Review. Update in: Cochrane Database Syst Rev. 2007;(4):CD001886.
Royston D, Levy JH, Fitch J, Dietrich W, Body SC, Murkin JM, Spiess BD, Nadel A
Full-dose aprotinin use in coronary artery bypass graft surgery: an analysis of perioperative pharmacotherapy and patient outcomes. Anesth Analg. 2006 Nov;103(5):1082-8.

The Influence of High-Dose Aprotinin and Tranexamic Acid on Bleeding Tendency and Allogeneic Blood Transfusion in Patients Undergoing Primary Aortic Valve Replacement or Coronary Artery Revascularization

Details for clinical trial NCT00396760

Clinical trial NCT00396760 - References