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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autoblood transfusion + leukocyte filter group | Experimental | In our department open surgery is considered as the standard procedure. The patients underwent open surgery, with autologous blood transfusion combined with a leukocyte filter. Blood transfusion based on bleeding during surgery. |
|
| Allogeneic blood transfusion group | No Intervention | In our department open surgery is considered as the standard procedure. The patients receives open surgery with allogeneic blood transfusion. Blood transfusion based on bleeding during surgery. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autoblood transfusion | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative and postoperative allogeneic blood transfusion rate | The number of allogeneic blood transfusion patients (Intraoperative or postoperative )/ the total number of patients | Through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of circulating tumor cells in the blood | Number of circulating tumor cells in the blood | within 30 days post-surgery |
| Incidence of transfusion related adverse reactions | the number of adverse reactions/ the total number of patients |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yu Zhang, Ph.D. | Contact | 8613602744495 | luck_2001@126.com | |
| Guoqing Zhong, M.D. | Contact | 8613417005047 | gqzhong@foxmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong provincial people's hospital | Recruiting | Guangzhou | Guangdong | 516008 | China |
After the research is completed, the data may be publicly shared depending on the outcome.
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randomized parallel controlled study
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|
| within 14 days post-surgery |
| occurence of new lesions | the number of patients with occurence of new lesions / the total number of patients | through study completion, an average of 1 year |
| ID | Term |
|---|---|
| D065227 | Transfusion Reaction |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007154 | Immune System Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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