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Study on the Efficacy and Safety of Topical Application of Tranexamic Acid in Cardiac Surgery with Cardiopulmonary Bypass

Evaluation of the Efficacy and Safety of Perioperative Topical Tranexamic Acid in Cardiac Surgery with Cardiopulmonary Bypass and Its Clinical Application and Promotion

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113718
Enrollment
Unknown
Registered
2025-12-02
Start date
2023-09-14
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac surgery with cardiopulmonary bypass

Interventions

Experimental Group:After the central venous catheter is induced and placed under general anesthesia, 2.5g of tranexamic acid is diluted into 100ml of warm saline, and after the main operation of cardi
Control group:Patients in the control group received the current standard clinical antifibrinolytic therapy protocol. Specifically: Loading dose: After general anesthesia induction and central venous

Sponsors

People's Hospital of Xinjiang Uygur Autonomous Region
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Male or female aged 18-70; (2) undergoing cardiopulmonary bypass heart surgery; (3) Signed written informed consent;

Exclusion criteria

Exclusion criteria: (1) Acquired color vision disorder; (2) Patients with active intravascular coagulation; (3) Those who have a history of convulsions or epilepsy in the past; (4) Allergy or contraindication to tranexamic acid injection or its components; (5) Lactating or pregnant women; 6) End-stage disease, with an estimated survival of less than 3 months; (7) Mentally or legally disabled patients; (8) concurrent participation in another perioperative interventional study;

Design outcomes

Primary

MeasureTime frame
Perioperative allogeneic red blood cell transfusion rate;Composite endpoint of major clinical events at 30 days postoperatively;

Secondary

MeasureTime frame
Volume of allogeneic red blood cell transfusion postoperation;Coagulation Function;Thromboelastography (TEG);Rate of rethoracotomy for hemostasis;Duration of postoperative mechanical ventilation;Volume of postoperative drainage;Length of ICU stay postoperation;Postoperative hospital stay;Total hospitalization cost;

Countries

China

Contacts

Public ContactYan Lei

People's Hospital of Xinjiang Uygur Autonomous Region

nmyanlei@yeah.net+86 991 856 2222

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026