Two Different Tranexamic Acid Regimens in Coronary Artery Bypass Surgery
NCT ID: NCT05994989
Last Updated: 2024-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
90 participants
OBSERVATIONAL
2023-08-14
2024-10-21
Brief Summary
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The study has been designed as a prospective observational research. The outcomes of two different tranexamic acid protocols applied during cardiovascular surgical procedures will be compared. The first group will consist of patients who receive a 10 mg/kg i.v. bolus of tranexamic acid after anesthesia induction, followed by an 8-hour i.v. tranexamic acid infusion at a dose of 2 mg/kg/hour. Group 2 will consist of patients who receive three doses of tranexamic acid, 10 mg/kg i.v. bolus after anesthesia induction, in the pump, and after protamine sulfate administration.
The cases collected over a period of 14 months will be divided into two groups and compared in terms of intraoperative and postoperative bleeding levels, as well as their need for blood products.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group 1
Patients who have undergone coronary artery bypass surgery and received intravenous tranexamic acid either as a bolus or infusion during the intraoperative period will be included in the study. The cases collected over a period of 6 months will be divided into two groups and compared.
The first group will consist of patients who receive a 10 mg/kg i.v. bolus of tranexamic acid after anesthesia induction, followed by an 8-hour i.v. tranexamic acid infusion at a dose of 2 mg/kg/hour.
No interventions assigned to this group
Group 2
Group 2 will consist of patients who receive three doses of tranexamic acid, 10 mg/kg i.v. bolus after anesthesia induction, in the pump, and after protamine sulfate administration.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Writen consent obtained
Exclusion Criteria
* Patients who operated on as emergencies
* Patients who have preoperative liver/renal dysfunction or a history of cerebrovascular events
* Patients under the age of 18
* Patients who have coagulation disorder
* Patients who have a history of allergies
* Pregnancy or lactation
* Disabled in spirit or law
18 Years
ALL
No
Sponsors
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Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
OTHER
Responsible Party
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Osman Uzundere
Principal Investigator
Locations
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Gazi Yaşargil Education and Research Hospital
Diyarbakır, , Turkey (Türkiye)
Countries
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References
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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.
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.
Tibi P, McClure RS, Huang J, Baker RA, Fitzgerald D, Mazer CD, Stone M, Chu D, Stammers AH, Dickinson T, Shore-Lesserson L, Ferraris V, Firestone S, Kissoon K, Moffatt-Bruce S. STS/SCA/AmSECT/SABM Update to the Clinical Practice Guidelines on Patient Blood Management. J Extra Corpor Technol. 2021 Jun;53(2):97-124. doi: 10.1182/ject-2100053. No abstract available.
Task Force on Patient Blood Management for Adult Cardiac Surgery of the European Association for Cardio-Thoracic Surgery (EACTS) and the European Association of Cardiothoracic Anaesthesiology (EACTA); Boer C, Meesters MI, Milojevic M, Benedetto U, Bolliger D, von Heymann C, Jeppsson A, Koster A, Osnabrugge RL, Ranucci M, Ravn HB, Vonk ABA, Wahba A, Pagano D. 2017 EACTS/EACTA Guidelines on patient blood management for adult cardiac surgery. J Cardiothorac Vasc Anesth. 2018 Feb;32(1):88-120. doi: 10.1053/j.jvca.2017.06.026. Epub 2017 Sep 30. No abstract available.
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.
Other Identifiers
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5.26.2023/408
Identifier Type: -
Identifier Source: org_study_id