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Prospective study for tranexamic acid in open spine surgery

Prospective study for tranexamic acid in open spine surgery

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900022344
Enrollment
Unknown
Registered
2019-04-06
Start date
2019-05-01
Completion date
Unknown
Last updated
2019-04-08

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

Conditions

Lumbar spinal stenosis, lumbar disc herniation, lumbar spondylolisthesis

Interventions

D:20mg/Kg intravenous TXA at 5 minutes before cutting the skin, and 10mg/Kg intravenous TXA at 3h, 6h, 12h and 24h respectively
E:40mg/Kg intravenous TXA at 5 minutes before cutting the skin, and 10mg/Kg intravenous TXA at 3h, 6h, 12h and 24h respectively
F:60mg/Kg intravenous TXA at 5 minutes before cutting the skin, and 10mg/Kg intravenous TXA at 3h, 6h, 12h and 24h respectively

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: (1) Patients who need surgery for spinal diseases such as lumbar spinal stenosis, lumbar disc herniation, and lumbar spondylolisthesis; (2) Normal platelet and coagulation function preoperatively; (3) Normal intravenous ultrasound in the lower extremities preoperatively; (4) To be able to and willing to provide signed informed consent

Exclusion criteria

Exclusion criteria: (1) Systemic infections such as pulmonary infection or urinary tract infection are not controlled preoperatively; (2) Abnormal immune function or combined immune-related disease preoperatively; (3) Abnormal inflammatory index preoperatively (C-reactive protein >20 mg/L); (4) Abnormal fibrinolysis index preoperatively (FDP > 5mg/L); (5) Discontinuation of oral anticoagulants or aspirin less than 1 week; (6) Allergy to tranexamic acid (TXA) or dexamethasone or have contraindications; (7) Patients at high risk of thrombosis; (8) History of deep vein thrombosis (VTE, calf muscle vein thrombosis or superficial vein thrombosis, pulmonary embolism); (9) Serious liver and kidney dysfunction.

Design outcomes

Primary

MeasureTime frame
Blood loss;Surgical field definition;Hb;ESR, CRP, IL-6, IL-10;perioperative complications: deep vein thrombosis;

Countries

China

Contacts

Public ContactQingquan Kong

Department of Orthopedics Surgery, West China Hospital, Sichuan University

kongspine@126.com+86 15982835131

Outcome results

None listed

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