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Comparison of Haemostatic Effects Between Conventional Tranexamic Acid and Tranexamic Acid Combined with Topical Bactrim in Posterior Scoliosis Correction and Fusion Surgery for Adolescent Idiopathic Scoliosis: A Prospective, Double-Blind, Randomised Controlled Clinical Study Protocol

Comparison of Haemostatic Effects Between Conventional Tranexamic Acid and Tranexamic Acid Combined with Topical Bactrim in Posterior Scoliosis Correction and Fusion Surgery for Adolescent Idiopathic Scoliosis: A Prospective, Double-Blind, Randomised Controlled Clinical Study Protocol

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500114559
Enrollment
Unknown
Registered
2025-12-15
Start date
2025-12-15
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Adolescent idiopathic scliosis

Interventions

Experimental Group One:Experimental Group 1 received a 50mg/kg intravenous infusion of TXA (diluted in 100ml saline) 15 minutes prior to surgical skin incision. During surgery, a maintenance dose of 1
Experimental Group Two:Experimental Group 2 received a 50mg/kg intravenous infusion of TXA (diluted in 100ml saline) 15 minutes prior to surgical skin incision. During surgery, a maintenance dose of 1
once mixed, indistinguishable from saline solution by visual inspection
barutine dosage selected based on graft fusion segments: 1 U of Barutine is required for two segments. For odd numbers of segments, apply rounding rules: 9/11/13/15 segments require 5U/6U/7U/8U respec

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
10 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 10 to 18 years diagnosed with AIS who underwent PSSF surgery. 2. Patients or their families consented to participate in this study and signed the relevant informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with severe underlying cardiovascular or cerebrovascular conditions unsuitable for surgery; 2. Patients with severe anaemia or coagulation disorders prior to surgery; 3. Individuals allergic to tranexamic acid (TXA) or bartitin; 4. Patients with severe hepatic or renal insufficiency; 5. Those with a history of thrombosis; 6. Patients still taking anticoagulants (e.g., aspirin) within two weeks prior to surgery; 7. Intraoperative dura mater injury resulting in cerebrospinal fluid leakage; 8. Patients and their families who refuse to participate in this study.

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