cervical and lumbar degeneration
Conditions
Interventions
Experimental group (A):rBAT
Control group (B):Placebo
Sponsors
Shanghai Ninth People’s Hospital, Shanghai JiaoTong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in clinical research; understand and be informed of this research and sign the Informed Consent Form (ICF); be willing to follow and have the ability to complete all experimental procedures; 2. Aged 18-70 years (calculated based on the date of signing the informed consent form); 3. Subjects who have been diagnosed with cervical and lumbar degenerative changes by the investigator and require posterior cervical laminectomy and laminoplasty, or who require double-space posterior lumbar interbody graft fusion ( subjects not subject to revision surgery); 4. According to the American Society of Anesthesiologists (ASA) disease assessment grading scale, the preoperative anesthesiologist judged the grade I-III (see Appendix 1 for the American Society of Anesthesiologists (ASA) condition assessment grading table for details): 5. During the screening period, the researchers determined that the cardiopulmonary function could meet the surgical requirements; 6. Female subjects must meet: (1) Menopause (defined as absence of menstruation for at least 1 year with no confirmed cause other than menopause), or (2) Have been surgically sterilized (removal of ovaries and/or uterus), or (3) Have fertility, but must meet: the serum pregnancy test within 7 days before the first drug must be negative, and agree to use effective contraceptive measures from signing the informed consent form to 28 days after the drug administration of the study (oral contraceptives are not accepted, acceptable use such as intrauterine contraceptive device or intrauterine system, double barrier method such as spermicide plus male condom, female condom, etc., or the spouse has undergone vasectomy) or maintain abstinence; 7. Male subjects must meet the requirements: agree to abstinence or take contraceptive measures, and stipulate that when the partner is a woman of childbearing age or the partner is pregnant, the male subject must agree to abstinence or take contraceptive measures from signing the informed consent form to 28 days after the administration of the test drug effective contraception.
Exclusion criteria
Exclusion criteria: 1. A history of malignant tumor within 5 years, excluding any type of carcinoma in situ that has been cured in the past and cured basal cell carcinoma of the skin or squamous cell carcinoma of the skin; 2. Cerebrovascular accident, transient ischemic attack, acute congestive heart failure, myocardial infarction, unstable angina pectoris, severe arrhythmia (including QTc interval >= 450 ms for men and >= 470 ms for women) within half a year (QTc The interval is calculated by Fridericia formula), or the subjects whose heart function class is greater than class II according to the New York Heart Association (NYHA) standard at screening (see Appendix 2 for the New York Heart Association (NYHA) standard heart function class for NYHA heart function class) ; 3. Participate in any interventional research (including drugs and devices, etc.) within 3 months before administration; 4. Anticoagulant drugs (such as aspirin, warfarin, etc.) or procoagulant drugs (such as vitamin K, aminotoluic acid, etc.) have been used within 7 days before administration; 5. History of thrombosis, hemophilia, antiphospholipid antibody syndrome, systemic lupus erythematosus, and homocysteinemia; 6. Those with clinically significant abnormality judged by the ultrasound investigator of the veins of the extremities during screening; 7. Those with uncontrolled blood sugar and blood pressure during screening (that is, fasting blood sugar greater than 8 mmol/L, systolic blood pressure >= 150 mmHg and/or diastolic blood pressure >= 100 mmHg); 8. Blood system and coagulation function during screening: (1) Hemoglobin = 1.5 x upper limit of normal (ULN); (4) Prothrombin time (PT) >= 1.5 x ULN; (5) International Normalized Ratio (INR) >= 1.5 x ULN; (6) Fibrinogen level ULN; 9. Significantly abnormal liver function at screening: AST or ALT or total bilirubin (TBIL) > 1.5 times ULN; 10. Impaired renal function at the time of screening: serum creatinine (sCr) > 1.5 times ULN; 11. Body mass index (BMI) >= 30 at screening (BMI = weight (kg)/height 2 (m2)); 12. Hepatitis B surface antigen (HBsAg) positive, or hepatitis C antibody (anti-HCV) positive at the time of screening, or human immunodeficiency virus (HIV) infected, or Treponema pallidum antibody positive; 13. During the screening, there are any infections that the investigators think are not suitable for participating in the study, including but not limited to combined with various infections that require further treatment, such as subjects with urinary tract infections, respiratory tract infections, diabetic foot infections, etc.; 14. The researcher judges that the subject has any other medical history or major clinically significant changes that may confound the research results or damage the various systems (mainly including but not limited to hematology, kidney, liver, endocrine, lung, digestion, heart, etc.) Vascular, psychiatric, neurological, metabolic or immune system diseases, etc.); 15. Those who are allergic to the test drug or its ingredients; 16. Female subjects are breastfeeding during the screening period, or have a positive pregnancy test result; 17. Female subjects who need hormone replacement therapy during the research period; 18. Female subjects who are expected to be in their menstrual period from the baseline period to 3 days after administration; 19. Any investigator foun
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood losss;venous thromboembolism; | — |
Secondary
| Measure | Time frame |
|---|---|
| postoperative drainage;hemoglobin changes; | — |
Countries
China
Contacts
Public ContactZhao Jie
Shanghai Ninth People’s Hospital, Shanghai JiaoTong University School of Medicine
Outcome results
None listed