NCT02579941 - 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)

Bonnar J, McNicol GP, Douglas AS
Coagulation and fibrinolytic mechanisms during and after normal childbirth. Br Med J. 1970 Apr 25;2(5703):200-3.
Brenner B
Haemostatic changes in pregnancy. Thromb Res. 2004;114(5-6):409-14. Review.
Cerneca F, Ricci G, Simeone R, Malisano M, Alberico S, Guaschino S
Coagulation and fibrinolysis changes in normal pregnancy. Increased levels of procoagulants and reduced levels of inhibitors during pregnancy induce a hypercoagulable state, combined with a reactive fibrinolysis. Eur J Obstet Gynecol Reprod Biol. 1997 May;73(1):31-6.
Collis RE, Collins PW
Haemostatic management of obstetric haemorrhage. Anaesthesia. 2015 Jan;70 Suppl 1:78-86, e27-8. doi: 10.1111/anae.12913. Review.
Faraoni D, Carlier C, Samama CM, Levy JH, Ducloy-Bouthors AS
[Efficacy and safety of tranexamic acid administration for the prevention and/or the treatment of post-partum haemorrhage: a systematic review with meta-analysis]. Ann Fr Anesth Reanim. 2014 Nov;33(11):563-71. doi: 10.1016/j.annfar.2014.07.748. Epub 2014 Oct 18. Review. French.
Ortmann E, Besser MW, Klein AA
Antifibrinolytic agents in current anaesthetic practice. Br J Anaesth. 2013 Oct;111(4):549-63. doi: 10.1093/bja/aet154. Epub 2013 May 9. Review.
Ronsmans C, Graham WJ; Lancet Maternal Survival Series steering group
Maternal mortality: who, when, where, and why. Lancet. 2006 Sep 30;368(9542):1189-200. Review.
Sentilhes L, Lasocki S, Ducloy-Bouthors AS, Deruelle P, Dreyfus M, Perrotin F, Goffinet F, Deneux-Tharaux C
Tranexamic acid for the prevention and treatment of postpartum haemorrhage. Br J Anaesth. 2015 Apr;114(4):576-87. doi: 10.1093/bja/aeu448. Epub 2015 Jan 8. Review.

Evaluation of the Minimum Concentration of Tranexamic Acid Required to Inhibit Fibrinolysis in a Population of Pregnant Women at Term.

Details for clinical trial NCT02579941

Clinical trial NCT02579941 - References