None
Conditions
Interventions
Experimental group1:Carboprost sodium (100ml, intravenous drip, used 30 minutes before surgery) combined with Tranexamic acid (1g, intravenous drip 10 minutes before surgery)
Experimental group2:Carboxymethyl sodium (100ml, for local use, rinse before closing the surgical incision) combined with tranexamic acid (1g, intravenous drip 10 minutes before surgery).
Control group:Tranexamic acid (1g, used preoperatively)
Sponsors
Shanghai Changzheng Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Can sign an informed consent form. 2. Age >= 18 years. 3. Meets the criteria for open spinal major surgery (a spinal surgery is defined as 'major' if it meets at least 2 of the following conditions: (1) expected surgical time > 2 hours; (2) expected intraoperative blood loss exceeds 15% of total blood volume; (3) decompression or fusion of >= 2 segments): including common degenerative spinal diseases (including cervical spondylosis, ossification of the posterior longitudinal ligament of the cervical spine, lumbar disc herniation, ossification of the ligamentum flavum of the thoracic spine), spinal fractures, spinal infections, primary tumors of the spine, metastatic tumors of the spine, intradural tumors, etc. 4. Can tolerate general anesthesia surgery.
Exclusion criteria
Exclusion criteria: 1. Refusal to participate in the trial. 2. Patients with bleeding disorders: such as hemophilia, systemic lupus erythematosus and other autoimmune diseases; or international normalized ratio (INR) > 1.5 × the upper limit of normal (ULN), prothrombin time (PT) > 1.5 × ULN, activated partial thromboplastin time (APTT) > 1.5 × ULN. 3. Significant liver or kidney dysfunction: post-liver or kidney transplant, hepatitis, liver failure, kidney failure, etc.; or serum total bilirubin > 1.5 × ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 2.5 × ULN. 4. Hemorrhagic diseases: allergic purpura, vitamin K deficiency, hereditary telangiectasia, idiopathic thrombocytopenic purpura, etc. 5. Allergic reaction to the study drug. 6. Antithrombotic medications not discontinued before surgery (Aspirin: stop 7 days before surgery; Warfarin: stop 5 days before surgery; Rivaroxaban: stop 3 days before surgery; low molecular weight heparin: stop 12 hours before surgery). 7. Manifest or occult cerebrospinal fluid leak (affecting the judgment of blood volume in postoperative drainage). 8. Obese patients (BMI >= 30). 9. Arterial thrombosis (such as myocardial infarction or stroke), arterial stent implantation, deep vein thrombosis, pulmonary embolism. 10. Blood transfusion or pregnancy within one month (affecting coagulation function).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total blood loss; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hidden blood loss;Intraoperative blood loss;Maximum hemoglobin drop;Perioperative blood transfusion volume;Coagulation parameters;Inflammatory marker levels;Perioperative visual analog scale (VAS) pain score;Frankel standard;Postoperative hospital stay;Incidence of thromboembolic events; | — |
Countries
China
Contacts
Public ContactBo Li
Shanghai Changzheng Hospital
Outcome results
None listed