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Combined use of rivaroxaban and tranexamic acid for hemorrhage and thrombosis management in spine surgery

Combined use of rivaroxaban and tranexamic acid for hemorrhage and thrombosis management in spine surgery

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800016430
Enrollment
Unknown
Registered
2018-06-01
Start date
2018-06-05
Completion date
Unknown
Last updated
2018-12-10

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

Conditions

Venous thromboembolism

Interventions

Control group:nothing
Tranexamic acid group:Preoperative and intraoperative application of tranexamic acid
Livashaban group:Oral rivaroxaban 8 h after surgery, applied 35 days after surgery

Sponsors

Qilu Hospital of Shandong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Adults aged 18 to 80 years; 2. Patients diagnosed with lumbar spinal stenosis or lumbar spondylolisthesis requiring posterior decompression and interbody fusion; 3. Anesthesia Risk Rating Scale ASA1- Level 3.

Exclusion criteria

Exclusion criteria: 1. Patients with PE or DVT; 2. Patients with obvious liver diseases (such as hepatitis B, hepatitis C, acute hepatitis, chronic active hepatitis, cirrhosis); 3. Patients with creatinine clearance 180 mmHg or diastolic blood pressure> 110 mmHg or unsatisfactory blood pressure control; 6. Pregnant women, pregnant women or breast-feeding women who have not taken contraceptive measures; CYP3A4 potent inhibitors; 7. patients with acquired color vision disorders; 8. patients with thrombin; 9. patients with a history of convulsions; 10. patients with thrombophilic atrial fibrillation, stent implantation Patients, patients with cardiac pacemakers, etc.; 11. patients who require minimally invasive spine surgery; 12. patients with long-term oral antiplatelet drugs; 13. patients with long-term metformin use; 14. Hb<90g/L; 15. Patients with tranexamic acid or rivaroxaban allergy.

Design outcomes

Primary

MeasureTime frame
bleeding volume during operation;bleeding volume after operation;Red blood count;Hemoglobin;D-dimer;Hematocrit;Prothrombin time;Activated partial thromboplastin time;Alanine aminotransferase;Aspartate transaminase;Creatinine;Urea nitrogen;Dual-leg vein ultrasound;Lumbar CT;

Countries

China

Contacts

Public ContactYunzhen Chen

Department of Orthopedics, Qilu Hospital of Shandong University

qilucyz@yeah.net+86 18560082566

Outcome results

None listed

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