A Single-center, Prospective, Randomized Controlled Study of the Safety and Efficacy of Autologous Transfusion in Spinal Surgery for Lung Cancer With Spinal Metastasis
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Spinal Metastases
- Sponsor
- Guangdong Provincial People's Hospital
- Enrollment
- 118
- Locations
- 1
- Primary Endpoint
- Intraoperative and postoperative allogeneic blood transfusion rate
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
The goal of this single-center prospective randomized controlled trial is to test and compare the safety and effectiveness of autologous blood transfusion in spinal surgery for lung cancer spinal metastases. The main questions it aims to answer are:
- Does autologous blood transfusion increase the incidence of new metastases?
- Does autologous blood transfusion affect postoperative hemoglobin levels and the number of circulating tumor cells in the blood?
- Can autologous blood transfusion reduce the rate of allogeneic transfusion during and after surgery for spinal metastases?
Detailed Description
In this study, participants underwent standard open spinal decompression surgery, and when blood transfusion was needed, autologous blood transfusion or allogeneic blood transfusion was used. Participants will be patients with lung cancer spinal metastases. Investigators will use flow cytometry, immunohistochemistry, and tumor cell culture methods to measure the number of circulating tumor cells in the blood before and after autologous blood transfusion. Investigators will compare participants who receive autologous blood transfusion with those who do not to observe if there are differences in: * The incidence of new metastases * The rate of allogeneic transfusion during and after surgery * Postoperative hemoglobin levels * The number of circulating tumor cells in the blood * The cost associated with transfusion
Investigators
Yu Zhang, PhD
Chief of Orthopedic Oncology
Guangdong Provincial People's Hospital
Eligibility Criteria
Inclusion Criteria
- •The age range is 18-75 years old;
- •The pathological diagnosis was lung cancer and spinal metastatic tumor;
- •Expected survival \> 3 months, can tolerate surgery;
- •Unstable spine; And/or spinal cord nerve compression, nerve function; Progressive decline, palliative spinal open decompression surgery
- •Patients with intraoperative/postoperative Hb\<90 g/L or other conditions requiring blood transfusion
Exclusion Criteria
- •Serious heart dysfunction or heart failure, diagnosed blood system diseases, coagulation disorders;
- •Severe renal insufficiency or need hemodialysis treatment;
- •Sepsis or septicemia;
- •Unable to obtain consent from the patient or family.
Outcomes
Primary Outcomes
Intraoperative and postoperative allogeneic blood transfusion rate
Time Frame: Through study completion, an average of 1 year
The number of allogeneic blood transfusion patients (Intraoperative or postoperative )/ the total number of patients
Secondary Outcomes
- Incidence of transfusion related adverse reactions(within 14 days post-surgery)
- occurence of new lesions(through study completion, an average of 1 year)
- Number of circulating tumor cells in the blood(within 30 days post-surgery)