The Safety and Efficacy of Autologous Transfusion in Spinal Surgery for Lung Cancer With Spinal Metastasis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Autoblood transfusion.
- Who it may be relevant to
- Registry conditions: Spinal Metastases, Blood Transfusion Complication, Lung Cancer, Surgery. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
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
- Procedure 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, antic
Primary outcome measures
- Intraoperative and postoperative allogeneic blood transfusion rate [Time frame: Through study completion, an average of 1 year]
Secondary outcome measures (3)
- Number of circulating tumor cells in the blood [Time frame: within 30 days post-surgery]
- Incidence of transfusion related adverse reactions [Time frame: within 14 days post-surgery]
- occurence of new lesions [Time frame: through study completion, an average of 1 year]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Guangdong provincial people's hospital — Guangzhou
Identifiers
NCT: NCT06244264 · SPMAT001