- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06244264
The Safety and Efficacy of Autologous Transfusion in Spinal Surgery for Lung Cancer With Spinal Metastasis
A Single-center, Prospective, Randomized Controlled Study of the Safety and Efficacy of Autologous Transfusion in Spinal Surgery for Lung Cancer With Spinal Metastasis
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?
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yu Zhang, Ph.D.
- Phone Number: 8613602744495
- Email: luck_2001@126.com
Study Contact Backup
- Name: Guoqing Zhong, M.D.
- Phone Number: 8613417005047
- Email: gqzhong@foxmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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
|
No Intervention: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of circulating tumor cells in the blood
Time Frame: within 30 days post-surgery
|
Number of circulating tumor cells in the blood
|
within 30 days post-surgery
|
Incidence of transfusion related adverse reactions
Time Frame: within 14 days post-surgery
|
the number of adverse reactions/ the total number of patients
|
within 14 days post-surgery
|
occurence of new lesions
Time Frame: through study completion, an average of 1 year
|
the number of patients with occurence of new lesions / the total number of patients
|
through study completion, an average of 1 year
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SPMAT001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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