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Different doses of aminocaproic acid in perioperative bleeding and blood transfusion during cardiopulmonary bypass cardiac surgery: a single-center, prospective, randomized controlled clinical trial

Different doses of aminocaproic acid in perioperative bleeding and blood transfusion during cardiopulmonary bypass cardiac surgery: a single-center, prospective, randomized controlled clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400088592
Enrollment
Unknown
Registered
2024-08-22
Start date
2024-09-01
Completion date
Unknown
Last updated
2024-08-26

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

Conditions

Bleeding during perioperative cardiac surgery

Interventions

Aminocaproic acid high dose group:Aminocaproic acid 80mg/kg, 20 minutes to pump the load, and then at a constant rate of 30mg/Kg/h per hour
Aminocaproic acid low dose group:Aminocaproic acid 60mg/kg, 20 minutes to pump the load, and then at a constant rate of 30mg/Kg/h per hour

Sponsors

Affiliated Hospital of Qingdao University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Age 18-80 years old; 2) Undergoing elective valve replacement/plasty (requiring cardiopulmonary bypass); 3) Sign informed consent;

Exclusion criteria

Exclusion criteria: 1) Previous history of cardiac surgery; 2) Severe liver dysfunction before operation; 3) Preoperative coagulation disorders, including inherited or acquired coagulation factor deficiency, thrombocytopenia, platelet dysfunction, or other bleeding disorders; 4) Take warfarin before surgery, INR>1.2 (or the upper limit of normal) after withdrawal; 5) Clopidogrel was discontinued for less than 5 days before surgery, and low molecular weight heparin was discontinued for less than 12 hours; 6) Allergy to allogeneic blood products. 7) Patients with preoperative cognitive dysfunction.

Design outcomes

Primary

MeasureTime frame
Bleeding amount within 24 hours after surgery;

Secondary

MeasureTime frame
The number of allogeneic red blood cell transfusions within 7 days after surgery (including intraoperative);ICU stay;

Countries

China

Contacts

Public ContactXiaojie Liu

Affiliated Hospital of Qingdao University

mmliuxiaojie@163.com+86 185 6185 7226

Outcome results

None listed

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