The safety and efficacy of different delivery methods of tranexamic acid in peri-operative period of posterior spinal surgery

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900026196

Enrollment

Unknown

Registered

2019-09-26

Start date

2019-09-25

Completion date

Unknown

Last updated

2019-09-30

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

Conditions

trauma, degenerative disease, tumor, infectious deseases or deformity of the spine

Interventions

A:2g oral TXA 2h before surgery, 2g oral TXA 2h, 6h, 10h postoperatively

B:2g oral TXA 2h before surgery, topical use of 1g TXA mixed with 20ml saline in the wound before skin closure.

C:intravenous injection of 30mg/kg TXA 15min before surgery, 30mg/kg intravenous TXA 2h, 6h, 10h postoperatively

D:intravenous injection of saline 15min before surgery, intravenous saline 2h, 6h, 10h postoperatively

E:2g oral TXA 2h before surgery, 1g oral TXA 2h, 6h, 10h postoperatively

F:intravenous injection of 10mg/kg TXA 15min before surgery, 10mg/kg intravenous TXA 2h, 6h, 10h postoperatively

G:intravenous injection of 50mg/kg TXA 15min before surgery, 5mg/Kg/h txa until skin closure.

H:intravenous injection of 10mg/kg TXA 15min before surgery, 2mg/Kg/h txa until skin closure.

I:2g oral TXA 2h before surgery, topical use of 20ml saline in the wound before skin closure.

J:2g oral TXA 2h before surgery, topical use of 1g TXA and 37.5mg bupivacaine (5ml) mixed with 15ml saline in the wound before skin closure.

K:intravenous injection of 30mg/kg TXA 15min before surgery, topical use of 1g TXA mixed with 20ml saline in the wound before skin closure.

Eligibility

Sex/Gender

All

Age

5 Years to 85 Years

Inclusion criteria

Inclusion criteria: All patients, who were scheduled to have posterior spinal surgery for trauma, degenerative disease, tumor, infectious deseases or deformity of the spine will be considered eligible for inclusion. Able 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) Discontinuation of oral anticoagulants or aspirin less than 1 week; (5) Allergy to tranexamic acid (TXA) or bupivacaine or have contraindications; (6) Patients at high risk of thrombosis; (7) History of deep vein thrombosis (VTE, calf muscle vein thrombosis or superficial vein thrombosis, pulmonary embolism); (8) serious liver and kidney dysfunction. (9) History of seizures and epilepsy.

Design outcomes

Primary

Measure	Time frame
Blood loss;Hb;ESR, CRP, IL-6;perioperative complications: deep vein thrombosis;VAS;Transfusion;Length of hospital stay;The amount of albumin;fibrinolysis index (D-Dimer, FDP);	—

Countries

China

Contacts

Public ContactXiaowei Yang

aowei3@163.com+86 18729214563

Outcome results

None listed

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