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Research on the effect of early administration of tranexamic acid on preoperative hidden blood loss in spinal fracture

Research on the effect of early administration of tranexamic acid on preoperative hidden blood loss in spinal fracture

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100044106
Enrollment
Unknown
Registered
2021-03-11
Start date
2021-03-07
Completion date
Unknown
Last updated
2021-07-21

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

Conditions

fracture and trauma of the spine

Interventions

tranexamic acid group:early administration of 20mg/kg tranexamic acid in patients with spinal fracture
placebo group:early administration of 0.9% NS in patients with spinal fracture

Sponsors

Subei People's Hospital of Jiangsu Province
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients with thoracolumbar fracture; 2. Patients with history of trauma; 3. Older than 18 years old; 4. No obvious bleeding in other organs; 5. Patients who voluntarily participate in clinical trials and sign informed consent and have good compliance.

Exclusion criteria

Exclusion criteria: 1. Patients with osteoporotic fracture; 2. Obvious bleeding in other organs; 3. Discontinuation of oral anticoagulants or aspirin less than 1 week; 4. Allergy to tranexamic acid (TXA) or bupivacaine or have contraindications; 5. Patients at high risk of thrombosis or history of thromboembolic events; 6. Serious liver and kidney dysfunction; 7. History of seizures and epilepsy.

Design outcomes

Primary

MeasureTime frame
HCT, Hb;fibrinolysis index (D-Dimer, FDP);ESR, CRP, IL-6;perioperative complications: deep vein thrombosis;Transfusion;

Countries

China

Contacts

Public ContactZhang Liang

Subei People's Hospital of Jiangsu Province

zhangliang6320@sina.com+86 18952578137

Outcome results

None listed

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