The Safety and Efficacy of Autologous Transfusion in Spinal Surgery for Lung Cancer With Spinal Metastasis
NCT ID: NCT06244264
Last Updated: 2024-07-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
118 participants
INTERVENTIONAL
2024-03-15
2027-12-31
Brief Summary
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* 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?
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Autoblood transfusion + leukocyte filter group
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.
Autoblood 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
Allogeneic blood transfusion group
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.
No interventions assigned to this group
Interventions
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Autoblood 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
Eligibility Criteria
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Inclusion Criteria
* 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
* Severe renal insufficiency or need hemodialysis treatment;
* Sepsis or septicemia;
* Unable to obtain consent from the patient or family.
18 Years
75 Years
ALL
No
Sponsors
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Guangdong Provincial People's Hospital
OTHER
Responsible Party
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Yu Zhang, PhD
Chief of Orthopedic Oncology
Locations
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Guangdong provincial people's hospital
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SPMAT001
Identifier Type: -
Identifier Source: org_study_id
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