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Trial Title:
The Safety and Efficacy of Autologous Transfusion in Spinal Surgery for Lung Cancer With Spinal Metastasis
NCT ID:
NCT06244264
Condition:
Spinal Metastases
Blood Transfusion Complication
Lung Cancer
Surgery
Autologous Blood Transfusion
Conditions: Official terms:
Lung Neoplasms
Neoplasm Metastasis
Transfusion Reaction
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
randomized parallel controlled study
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Autoblood transfusion
Description:
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
Arm group label:
Autoblood transfusion + leukocyte filter group
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
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Guangdong provincial people's hospital
Address:
City:
Guangzhou
Zip:
516008
Country:
China
Status:
Recruiting
Contact:
Last name:
Guoqing Zhong, M.D.
Email:
gqzhong@foxmail.com
Start date:
March 15, 2024
Completion date:
December 31, 2027
Lead sponsor:
Agency:
Guangdong Provincial People's Hospital
Agency class:
Other
Source:
Guangdong Provincial People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06244264
