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Study on the safety and efficacy of tranexamic acid on bleeding in spinal surgery

Study on the safety and efficacy of sequential application of tranexamic acid in perioperative period for hemorrhage in posterior spinal surgery

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200064659
Enrollment
Unknown
Registered
2022-10-13
Start date
2022-10-01
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Spinal diseases

Interventions

Group A:Patients were intravenously infused with tranexamic acid before skin incision, and the same amount of normal saline or other placebo was used at the same time point as group B after operation.
Group B:Patients received intravenous infusion of tranexamic acid before skin incision and tranexamic acid at different time points after operation.

Sponsors

The First Affiliated Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. The diagnosis of our hospital is: (1) Lumbar degenerative disease; (2) Cervical degenerative disease; (3) Thoracic degenerative diseases; (4) Adolescent idiopathic scoliosis; (5) Spinal kyphosis; (6) Spinal tumors; (7) Spinal fractures; (8) Spine-related diseases such as spinal tuberculosis, and patients who need spinal-related surgery; 2. Those who voluntarily joined the study and signed informed consent; 3. Preoperative hemoglobin (Hb) and coagulation function were normal; 4. No abnormal lower extremity venous ultrasound.

Exclusion criteria

Exclusion criteria: 1. Preoperative anemia (Hb: female III; 8. Patients with history of any psychiatric illness; 9. Patients who have undergone lumbar surgery in the past; 10. Patients combined with lumbar tumour, tuberculosis, infection or lumbar vertebral fracture caused by trauma.

Design outcomes

Primary

MeasureTime frame
Basic demographic parameters ( age, gender, height, weight, etc. );Blood loss related parameters (total blood loss,postoperative blood loss, dominant blood loss, hidden blood loss, intraoperative blood loss, drainage fluid blood content, etc. );Bood routine (Hct, Hb, RBC, PLT);Coagulation and fibrinolysis indexes (PT, INR, APTT, TT, FIB, FDP, D-D);Coagulation factors (II, V, VII, VIII, IX, X, XI, XII);Liver and kidney function (ALb, ALT, AST, BUN, Cr);Inflammatory response related indicators;Thrombelastogram (TEG);Length of stay ( total length of stay, preoperative length of stay, postoperative length of stay, etc. );Drainage tube removal time, postoperative bed rest time to ambulation time, etc.;Postoperative complication(exudation, hematoma, infection, etc.);The incidence of thrombosis (deep vein thrombosis, muscular calf vein thrombosis, pulmonary embolism, myocardial infarction, etc.);Medical expenses;Duration of operation (min), length of incision (cm);Postoperative wound drainage volume, HCT of postoperative wound drainage fluid;Pain-related parameter indicators;Anesthesia related parameters ( ASA classification, cardiopulmonary function classification, Mallampati classification, etc. );Clinical diagnosis, past history, osteoporosis, etc.;Chalybeate, EPO, anti-inflammatory and analgesic drugs and other drugs use and follow-up.;

Countries

China

Contacts

Public ContactZhenming Hu

The First Affiliated Hospital of Chongqing Medical University

spinecenter@163.com+86 13628326226

Outcome results

None listed

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