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Investigation of the standardized dosing regimen of tranexamic acid in perioperative period of total joint arthroplasty

Investigation of the standardized dosing regimen of tranexamic acid in perioperative period of total joint arthroplasty

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-17011896
Enrollment
Unknown
Registered
2017-07-06
Start date
2017-08-01
Completion date
Unknown
Last updated
2017-07-10

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

Conditions

total joint arthroplasty

Interventions

TKA-control:not giving TXA
TKA-IV:1g of tranexamic acid intravenouly administered 10-15 minutes before the tourniquet was applied/inflated for 20 minutes and one more dose of 1g given at 3 hours after the first dose.
TKA-IA:2g of tranexamic acid injected into joint cavity after suturing joint capsule and the drainage clamped for 2 hours then activated.
TKA-combined:1g of tranexamic acid intravenously administered 10-15 minutes before the tourniquet was applied/inflated for 20 minutes and 2g tranexamic acid injected into joint cavity after suturing j
THA-control:not giving TXA
THA-IV:1g of tranexamic acid intravenously administered 10-15 minutes before incision for 20 minutes and one more dose of 1g given at 3 hours after the first dose.
THA-IA:2g of tranexamic acid injected into joint cavity after suturing joint capsule . The drain was closed for 2 hours and then activated.
THA-combined:1g of tranexamic acid intravenously administered 10-15 minutes before incision for 20 minutes and 2g of tranexamic acid injected into joint cavity after suturing joint capsule .The drain

Sponsors

Drum Tower Hospital Affiliated to Medical School of Nanjing University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients aged 50-85 years old with degenerative osteoarthritis; 2) Patients using tranexamic acid in venous and local administration during unilateral primary total knee or hip arthroplasty; 3) Patients signing the informed consent .

Exclusion criteria

Exclusion criteria: 1) Patients with an allergy to tranexamic acid; 2) Patients with a history of coagulopathy; 3) Patients with a history of venous thrombembolism (deep venous thrombosis, superficial venous thrombosis, calf muscular venous thrombosis or pulmonary embolism); 4) Patients with severe liver (exceeds the normal upper limit by 2 times ) or kidney (creatinine clearance <15ml / min) dysfunction; 5) Patients with cardiovascular or cerebrovascular disease (with myocardial infarction ,cerebral infarction, angina pectoris, atrial fibrillation or shock history) 6) Patients with hemoglobin <100g / L or the use of anticoagulants (including warfarin, heparin, low molecular weight heparin, rivaroxaban, apixaban, dabigatran, hirudin Etc.) before surgery; 7) Patients with the use of antiplatelet agents (including aspirin, clopidogrel, prasugrel, ticagrelor, dipyridamole, ginkgo-damole) within 7 days before surgery; 8) Patients with the use of thrombolytic drugs (including urokinase, alteplase, etc.) within 7 days before surgery; 9) Patients with the use of Chinese patent drugs containing Salvia, Chuanxiong, hirudin for blood-activating and stasis-dissolving (including compound Danshen dripping pills, Xuefu Zhuyu oral liquid, Tongxinluo capsules, Lemai granules, Huoxuetongmai tablets, Danqi Tablets, Buchangnaoxintong Capsule, Shuxin Oral Liquid, Huoxing pill) within 7 days before surgery; 10) Patients with the use of hemostatic drugs (including tranexamic acid, aminocaproic acid, aminoacetic acid, phenol sulfonamide, pituitrin, norepinephrine, somatostatin, aprotinin, thrombin, coagulation factors, etc.) or plasma products for hemostasis within 7 days before surgery , or patients with massive hemorrhage within a month before surgery; 11) Patients with the perioperative use of drugs that can dilute or concentrate blood (eg mannitol, etc.) or elevate the level of blood cells..

Design outcomes

Primary

MeasureTime frame
Intraoperative blood loss;Postoperative discharge;Preoperative hemoglobin;Postoperative haemoglobin;Blood transfusion and transfusion rate;Tranexamic acid plasma concentration during period;Efficacy index of tranexamic acid;Postoperative thrombosis event;

Secondary

MeasureTime frame
Preoperative HCT;Postoperative HCT;Hospital stay;

Countries

China

Contacts

Public ContactQing Jiang

Drum Tower Hospital Affiliated to Medical School of Nanjing University

jiangqing112@hotmail.com+86 13605192953

Outcome results

None listed

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