NCT00910182 - 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)

Harbrecht BG, Peitzman AB, Rivera L, Heil B, Croce M, Morris JA Jr, Enderson BL, Kurek S, Pasquale M, Frykberg ER, Minei JP, Meredith JW, Young J, Kealey GP, Ross S, Luchette FA, McCarthy M, Davis F 3rd, Shatz D, Tinkoff G, Block EF, Cone JB, Jones LM, Chalifoux T, Federle MB, Clancy KD, Ochoa JB, Fakhry SM, Townsend R, Bell RM, Weireter L, Shapiro MB, Rogers F, Dunham CM, McAuley CE
Contribution of age and gender to outcome of blunt splenic injury in adults: multicenter study of the eastern association for the surgery of trauma. J Trauma. 2001 Nov;51(5):887-95.
Pachter HL, Guth AA, Hofstetter SR, Spencer FC
Changing patterns in the management of splenic trauma: the impact of nonoperative management. Ann Surg. 1998 May;227(5):708-17; discussion 717-9.
Pachter HL, Spencer FC, Hofstetter SR, Liang HG, Hoballah J, Coppa GF
Experience with selective operative and nonoperative treatment of splenic injuries in 193 patients. Ann Surg. 1990 May;211(5):583-9; discussion 589-91.
Peitzman AB, Heil B, Rivera L, Federle MB, Harbrecht BG, Clancy KD, Croce M, Enderson BL, Morris JA, Shatz D, Meredith JW, Ochoa JB, Fakhry SM, Cushman JG, Minei JP, McCarthy M, Luchette FA, Townsend R, Tinkoff G, Block EF, Ross S, Frykberg ER, Bell RM, Davis F 3rd, Weireter L, Shapiro MB
Blunt splenic injury in adults: Multi-institutional Study of the Eastern Association for the Surgery of Trauma. J Trauma. 2000 Aug;49(2):177-87; discussion 187-9.
Watson GA, Rosengart MR, Zenati MS, Tsung A, Forsythe RM, Peitzman AB, Harbrecht BG
Nonoperative management of severe blunt splenic injury: are we getting better? J Trauma. 2006 Nov;61(5):1113-8; discussion 1118-9.

Outcome After Conservative and Surgical Treatment of Splenic Injuries After Blunt Abdominal Trauma. Retrospective Study 2002-2008.

Details for clinical trial NCT00910182

Clinical trial NCT00910182 - References