The Safety and Efficacy of Autologous Transfusion in Spinal Surgery for Lung Cancer With Spinal Metastasis

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06244264
• Other study ID #: SPMAT001
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Autologous Blood Transfusion
• Blood Transfusion Complication
• Lung Cancer
• Lung Neoplasms
• Neoplasm Metastasis
• Spinal Metastases
• Surgery
• Transfusion Reaction

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