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Study on safety and efficacy of tranexamic acid combined with gum in spinal surgery

The safety and efficacy of perioperative application of tranexamic acid combined with chewing gum in reducing bleeding and improving gastrointestinal dysfunction in orthopedic surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300067944
Enrollment
Unknown
Registered
2023-02-01
Start date
2023-02-01
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

Orthopedic related diseases

Interventions

Group A:Before skin incision, tranexamic acid was intravenously infused. After operation, tranexamic acid was used at the same time point in group B, and gum was not chewed after operation.
Group B:Tranexamic acid was infused intravenously before skin incision. Tranexamic acid was used at different time points after operation, and chewing gum at different time points was selected.

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: 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.Spinal tuberculosis; 9.Degenerative hip disease; 10.Patients with orthopedic-related diseases such as knee degenerative diseases and requiring orthopedic-related surgery; Voluntarily join this study and sign the informed consent form; Preoperative hemoglobin (Hb) and coagulation function were normal; 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.);Gastrointestinal function indicators (first defecation, exhaust, bowel sound recovery time, constipation, abdominal distension, nausea, vomiting,oral comfort, etc.);Liver and kidney function (prealbumin, total protein, Alb, ALT, AST, BUN, Cr ,etc.);Inflammatory response related indicators;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.);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.;

Secondary

MeasureTime frame
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(???????????????);Thrombelastogram(TEG);The incidence of thrombosis ( deep vein thrombosis, muscular calf vein thrombosis, pulmonary embolism, myocardial infarction, etc.);

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