Postoperative Hemorrhage — Two Different Tranexamic Acid Regimens in Coronary Artery Bypass Surgery
Citation(s)
Guo J, Gao X, Ma Y, Lv H, Hu W, Zhang S, Ji H, Wang G, Shi J Different dose regimes and administration methods of tranexamic acid in cardiac surgery: a meta-analysis of randomized trials. BMC Anesthesiol. 2019 Jul 15;19(1):129. doi: 10.1186/s12871-019-0772-0.
Madathil T, Balachandran R, Kottayil BP, Sundaram KR, Nair SG Comparison of efficacy of two different doses of tranexamic acid in prevention of post operative blood loss in patients with congenital cyanotic heart disease undergoing cardiac surgery. Ann Card Anaesth. 2021 Jul-Sep;24(3):339-344. doi: 10.4103/aca.ACA_162_20.
Zhou ZF, Zhai W, Yu LN, Sun K, Sun LH, Xing XF, Yan M Comparison of the in-vivo effect of two tranexamic acid doses on fibrinolysis parameters in adults undergoing valvular cardiac surgery with cardiopulmonary bypass - a pilot investigation. BMC Anesthesiol. 2021 Feb 2;21(1):33. doi: 10.1186/s12871-021-01234-8.
The Effect of Two Different Tranexamic Acid Dose Regimens on Intraoperative and Postoperative Bleeding in Coronary Artery Bypass Surgery
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
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.
