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

Guangdong Provincial People's Hospital (Guangdong Provincial Academy of Medical Sciences)

Status: Enrolling

Conditions: Blood Transfusion Complication; Autologous Blood Transfusion; Spinal Metastases; Surgery; Lung Cancer

Treatments: Procedure: Autoblood transfusion

Study type: Interventional

Funder types: Other

Identifiers

NCT06244264

SPMAT001

Details and patient eligibility

About

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?

Full 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

Enrollment: 118 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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118 participants in 2 patient groups

Autoblood transfusion + leukocyte filter group

Experimental group

Description:

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.

Treatment:

Procedure: Autoblood transfusion

Allogeneic blood transfusion group

No Intervention group

Description:

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.