The effects of multiple doses of oral tranexamic acid on postoperative blood loss, coagulation, and knee function in patients undergoing ACL reconstruction

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000032056

Enrollment

Unknown

Registered

2020-04-19

Start date

2020-04-18

Completion date

Unknown

Last updated

2020-05-04

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

Conditions

ACL reconstruction

Interventions

A:IV 20mg/kg TXA before tourniquet release

B:IV 20mg/kg TXA before tourniquet release, and oral 1 g TXA after 3h postoperatively

C:IV 20mg/kg TXA before tourniquet release, and oral 1g TXA after 3 and 7h postoperatively

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. ACL reconstruction is needed in patients with ACL rupture; 2. Patients with normal platelet and coagulation function before operation; 3. Those patients who had no abnormality in color Doppler ultrasonography of the veins of both lower limbs before operation; 4. Patients who voluntarily participate in the clinical trial and sign the informed consent and have good compliance.

Exclusion criteria

Exclusion criteria: 1. Patients with uncontrolled systemic infection such as pulmonary infection and urinary tract infection before operation; 2. Patients with abnormal immune function or immune related diseases before operation; 3. Patients with abnormal preoperative inflammatory index (CRP > 20 mg / L); 4. Patients with abnormal preoperative fibrinolysis index (FDP > 5 mg / L); 5. Patients who took anticoagulants or aspirin for less than 1 week; 6. Patients who are allergic to tranexamic acid or have contraindications; 7. Patients at high risk of thrombosis, including AF, pacemaker and stent implantation; 8. Patients with history of venous thromboembolism, pulmonary embolism, cerebral infarction and coronary heart disease; 9. Patients with severe hepatorenal insufficiency.

Design outcomes

Primary

Measure	Time frame
Blood loss;Coagulation index;	—

Secondary

Measure	Time frame
Inflammation index;Hb;Hct;DVT, PE;Transfusion;Swelling;Hemorrhage;VAS pain score;color Doppler Ultrasonic (CDU) examination in lower extremity;ROM;IKDC;Lysholm;Muscle strength;Satisfaction scores;Complications;Hemarthrosis;Aspiration;	—

Countries

China

Contacts

Public ContactJian Li

West China Hospital of Sichuan University

18980601388@163.com+86 18980601388

Outcome results

None listed

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