Search for optimum dose and timing of tranexamic acid administration in cardiac surgery with cardiopulmonary bypass.

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-UMIN000003327
• Date of registration: 13/03/2010
• Prospective Registration: Yes
• Primary sponsor: Bellland General Hospital
• Public title: Search for optimum dose and timing of tranexamic acid administration in cardiac surgery with cardiopulmonary bypass.
• Scientific title: Search for optimum dose and timing of tranexamic acid administration in cardiac surgery with cardiopulmonary bypass. - Search for optimum dose and timing of tranexamic acid administration in cardiac surgery with cardiopulmonary bypass.
• Date of first enrolment: 2010/05/01
• Target sample size: 140
• Recruitment status: Complete: follow-up complete
• URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003885
• Study type: Interventional
• Study design: Parallel Randomized
• Phase: Phase IV

Countries of recruitment

Japan

Contacts

• Name: Toshinori Horiuchi
• Affiliation: Bellland General Hospital Department of Anesthesia

• Name: Toshinori Horiuchi
• Affiliation: Bellland General Hospital Department of Anesthesia

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion criteria: urgent/emergency operation, sepsis, infectious endocarditis, using IABP, renal insufficiency (Cre>2.0), active hepatitis, platerets<50000, preoperative hemostatic abnormality, continuous anticoagulant therapy, therapy with self blood, therapy with thrombin, allergy with taranexamic acid, patients recognised as inadequate for the study.

Age minimum: 20years-old
Age maximum: Not applicable
Gender: Male and Female

Health Condition(s) or Problem(s) studied

cardiac insufficiency requiring surgery (for the patients undergoing cardiac surgery with cardiopulmonary bypass)

Intervention(s)

Group of NORMAL DOSE BEFORE CPB a)30mg/kg b)16mg/kg/h c)2mg/kg d)NS (CPB: cardiopulmonary bypass, NS: normal saline) a) loading dose before CPB b) maintenance dose after loading (5 hours) c) priming dose in CPB circuit d) dose after CPB and protamine administration
Group of LOWER DOSE BEFORE CPB a)8mg/kg b)4mg/kg/h c)0.6mg/kg d)NS (CPB: cardiopulmonary bypass, NS: normal saline) a) loading dose before CPB b) maintenance dose after loading (5 hours) c) priming dose in CPB circuit d) dose after CPB and protamine administration
Group of AFTER CPB a)NS b)NS c)NS d)2g (CPB: cardiopulmonary bypass, NS: normal saline) a) loading dose before CPB b) maintenance dose after loading (5 hours) c) priming dose in CPB circuit d) dose after CPB and protamine administration
Control group a)NS b)NS c)NS d)2NS (CPB: cardiopulmonary bypass, NS: normal saline) a) loading dose before CPB b) maintenance dose after loading (5 hours) c) priming dose in CPB circuit d) dose after CPB and protamine administration

Primary Outcome(s)

blood loss in 24 hours after surgery

Secondary Outcome(s)

intraoperative blood loss intraoperative transfusion blood loss in 6 hours after surgery blood loss in 12 hours after surgery total blood loss after surgery transfusion after surgery hemostatic variavles before and after culdiopulmonary bypass cytokines before and after culdiopulmonary bypass postoperative complications duration of mechanical ventilation duration of intensive care unit stay

Source(s) of Monetary Support

Ministry of Education, Culture, Sports, Science and Technology

Daiichi-Sankyo Company

Ethics review

Status: YES
Approval date:
Contact:

Results

• Results available: Yes
• Date Completed: 01/04/2012