Intraoperative bleeding in orthopedic surgery
Conditions
Interventions
Test group:Subjects receive absorbable hemostatic fluid gelatin mixed with thrombin powder for auxiliary hemostasis during orthopedic surgery.
Control group:Subjects receive absorbable hemostatic fluid gelatin for auxiliary hemostasis during orthopedic surgery.
Sponsors
Shanghai Sixth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18-75 years (including 18 and 75 years old), with no restriction on gender; 2.Patients scheduled to undergo orthopedic (spinal cord) surgery; 3.Patients who can understand the purpose of the trial, voluntarily participate in the trial, are willing to sign a written informed consent form, and can and are willing to complete all examinations and follow-ups.
Exclusion criteria
Exclusion criteria: 1.Patients with systemic infection or infection at the surgical site; 2.Patients with coagulation dysfunction (judged by the investigator, those with prothrombin time (PT) or activated partial thromboplastin time (APTT) exceeding the upper limit of the normal reference range and with clinically significant abnormalities); 3.Patients who have taken anticoagulants/antiplatelet drugs within 1 week before surgery; 4.Patients with known allergies or hypersensitivity to porcine-derived gelatin and/or thrombin, or patients who refuse to use porcine-derived medical products; 5.Lactating or pregnant female patients, or patients with plans for childbearing during the clinical trial; 6.Patients who have participated in or are participating in a drug clinical trial within 3 months, or have participated in or are participating in other medical device clinical trials within 30 days; 7.Other circumstances deemed inappropriate for participation in the trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemostasis success time; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change value of hemoglobin content;Intraoperative blood loss;Intraoperative blood transfusion volume;Operation time;Length of hospital stay; | — |
Countries
China
Contacts
Public ContactLian Xiaofeng
Shanghai Sixth People's Hospital
Outcome results
None listed