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A Comparative Study of Haemostasis Effects Between Conventional Tranexamic Acid and Tranexamic Acid Combined with Local Bactrim in Percutaneous Interlaminar Lumbar Interbody Fusion: A Prospective, Double-Blind, Randomised Controlled Clinical Trial Protocol

A Comparative Study of Haemostasis Effects Between Conventional Tranexamic Acid and Tranexamic Acid Combined with Local Bactrim in Percutaneous Interlaminar Lumbar Interbody Fusion: A Prospective, Double-Blind, Randomised Controlled Clinical Trial Protocol

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500114028
Enrollment
Unknown
Registered
2025-12-05
Start date
2025-12-08
Completion date
Unknown
Last updated
2025-12-08

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

Experimental Group One:Experimental Group 1 received a 50 mg/kg intravenous infusion of TXA (diluted in 100 ml saline) 15 minutes prior to surgical skin incision. During surgery, a maintenance dose of
Experimental Group Two:Experimental Group 2 received a 50 mg/kg intravenous infusion of TXA (diluted in 100 ml saline) 15 minutes prior to surgical skin incision. with a maintenance dose of 10mg/kg·h
dosage selected based on the number of fusion segments, with 3U of bacitracin required per segment).

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients requiring lumbar TLIF surgery for giant disc herniation, recurrent disc herniation, intervertebral pseudoarthrosis, and symptomatic lumbar spondylolisthesis; 2. Patients are >=18 years old and <=80 years old; 3. Patients agree to participate in this study and sign the relevant informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients undergoing secondary revision surgery; 2. Patients with a history of cardiovascular or cerebrovascular accidents, or those with severe underlying cardiovascular or cerebrovascular conditions rendering them unsuitable for surgery; 3. Patients with severe anaemia or coagulation disorders preoperatively; 4. Patients allergic to TXA or bartitin; 5. Patients with severe hepatic or renal insufficiency; 6. Patients with a history of thrombosis (e.g., DVT or PE); 7. Patients still taking anticoagulants (e.g., aspirin) within two weeks prior to surgery; 8. Intraoperative dura mater injury resulting in cerebrospinal fluid leakage.

Design outcomes

Primary

MeasureTime frame
Total blood loss;

Secondary

MeasureTime frame
Change in fibrinolytic parameters;Occult blood loss;Postoperative drainage volume;Maximum haemoglobin loss;Length of hospital stay;Incidence of complications;

Countries

China

Contacts

Public ContactLiu Limin

West China Hospital, Sichuan University

liulimin_spine@163.com+86 189 8060 1394

Outcome results

None listed

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