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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06244264
Other study ID # SPMAT001
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 15, 2024
Est. completion date December 31, 2027

Study information

Verified date February 2024
Source Guangdong Provincial People's Hospital
Contact Yu Zhang, Ph.D.
Phone 8613602744495
Email luck_2001@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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?


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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 118
Est. completion date December 31, 2027
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Intervention

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, 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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Guangdong Provincial People's Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary Number of circulating tumor cells in the blood Number of circulating tumor cells in the blood within 30 days post-surgery
Secondary Incidence of transfusion related adverse reactions the number of adverse reactions/ the total number of patients within 14 days post-surgery
Secondary 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
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