NCT05809141 - 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)

Amitrano L, Guardascione MA, Brancaccio V, Balzano A
Coagulation disorders in liver disease. Semin Liver Dis. 2002 Feb;22(1):83-96. doi: 10.1055/s-2002-23205.
Chronic hepatitis and autoimmune chronic active hepatitis
In: Alex P.Movat (eds). Liver disorders in childhood 3rd edition. Oxford, Butterworth- Heinemann Ltd, 1994, pp. 180-96.
He Y, Yao H, Ageno W, Mendez-Sanchez N, Guo X, Qi X
Review article: thromboelastography in liver diseases. Aliment Pharmacol Ther. 2022 Aug;56(4):580-591. doi: 10.1111/apt.17080. Epub 2022 Jun 14.
Janko N, Majeed A, Kemp W, Roberts SK
Viscoelastic Tests as Point-of-Care Tests in the Assessment and Management of Bleeding and Thrombosis in Liver Disease. Semin Thromb Hemost. 2020 Sep;46(6):704-715. doi: 10.1055/s-0040-1715475. Epub 2020 Sep 15.
Sharma A, Nagalli S
Chronic liver disease. InStatPearls [Internet] 2021 Nov 25. StatPearls Publishing.
Versteeg HH, Heemskerk JW, Levi M, Reitsma PH
New fundamentals in hemostasis. Physiol Rev. 2013 Jan;93(1):327-58. doi: 10.1152/physrev.00016.2011.
Viral hepatitis/Chronic hepatitis/Portal hypertension
In: Sherlock S, Dooley J, (eds). Diseases of liver and biliary system 10th edition. Oxford, Blackwell Science Ltd, 1997, pp. 162-3, 265-333.
Yang LL
Anatomy and Physiology of the Liver. Anesthesia for Hepatico-Pancreatic-Biliary Surgery and Transplantation. 2021:15-40.

Comparison Between Thromboelastography and Conventional Coagulation Tests in Pediatrics With Chronic Liver Disease

Clinical trial NCT05809141 - References