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Effect of infusion of tranexamic acid at different concentrations on the incidence of nausea and vomiting in patients undergoing lumbar interbody fusion via transforaminal approach: a prospective, double-blind, randomised controlled clinical study protocol

Effect of infusion of tranexamic acid at different concentrations on the incidence of nausea and vomiting in patients undergoing lumbar interbody fusion via transforaminal approach: a prospective, double-blind, randomised controlled clinical study protocol

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110642
Enrollment
Unknown
Registered
2025-10-16
Start date
2025-10-21
Completion date
Unknown
Last updated
2025-10-20

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

Conditions

Degenerative diseases of the lumbar spine

Interventions

Sponsors

West China Tianfu Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients who need lumbar TLIF surgery for giant disc herniation, recurrent disc herniation, intervertebral pseudoarthrosis, symptomatic lumbar spondylolisthesis, etc; 2. The patient is >=18 years old and <=80 years old; 3. The patient does not have any congenital disease; 4. The patient does not have any blood system disease; 5. Patients agree to participate in this study and sign the relevant informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients who are not suitable for lumbar TLIF surgery because of extensive epidural scarring, arachnoiditis, active infection, nerve root degeneration, or severe osteoporosis; 2. Patients are allergic to TXA; 3. Patients with liver or kidney insufficiency; 4. Patients with history of thrombosis; 5. The patient is younger than 18 years old or older than 80 years old; 6. Patients with severe cardiovascular and cerebrovascular and other underlying diseases that are not suitable for surgery; 7. Patients with intraoperative dural injury that produces cerebrospinal fluid leakage; 8. Patients and their families refused to participate in this study.

Design outcomes

Primary

MeasureTime frame
Incidence and severity of postoperative nausea and vomiting following tranexamic acid infusion administered 6 hours after surgery;

Secondary

MeasureTime frame
Electrolyte profile (sodium potassium magnesium calcium chloride);Postoperative blood loss;Hospitalisation satisfaction;Incidence of VTE;Postoperative drainage;Length of Hospital Stay;Fibrinolysis Markers;

Countries

China

Contacts

Public ContactLiu Li

Sichuan University West China Tianfu Hospital

liuli_guke@163.com+86 189 8060 6109

Outcome results

None listed

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