Autologous Blood Transfusion, Blood Transfusion Complication, Lung Cancer, Spinal Metastases, Surgery
Conditions
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
Interventions
PROCEDUREAutoblood transfusion
Through a negative pressure suction device, the patient's blood that flows out during surgery is collected into a blood storage filter. During the suction process, it is mixed with an appropriate anticoagulant and passed through multiple layers of filters. When the volume of recovered blood reaches a certain level, it is continuously (or intermittently) centrifuged. Using a high-speed centrifugal blood recovery tank, the red blood cells are separated, and the plasma, waste, cell fragments, anticoagulants, and harmful components are diverted into a waste bag. A large amount of saline is used to repeatedly wash, purify, and concentrate the red blood cells. Finally, the concentrated red blood cells are prepared into a 70% red blood cell suspension with saline and stored in a collection bag for transfusion back to the patients. Open surgery is considered as the standard procedure for metastatic spinal cord compression
Sponsors
Guangdong Provincial People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
randomized parallel controlled study
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative and postoperative allogeneic blood transfusion rate | Through study completion, an average of 1 year | The number of allogeneic blood transfusion patients (Intraoperative or postoperative )/ the total number of patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of circulating tumor cells in the blood | within 30 days post-surgery | Number of circulating tumor cells in the blood |
| Incidence of transfusion related adverse reactions | within 14 days post-surgery | the number of adverse reactions/ the total number of patients |
| occurence of new lesions | through study completion, an average of 1 year | the number of patients with occurence of new lesions / the total number of patients |
Countries
China
Contacts
Primary ContactYu Zhang, Ph.D.
Backup ContactGuoqing Zhong, M.D.
Outcome results
None listed