Clinical trial NCT06244264: The Safety and Efficacy of Autologous Transfusion in Spinal Surgery for Lung Cancer With Spinal Metastasis
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Metastases
Blood Transfusion Complication
Lung Cancer
Surgery
Autologous Blood Transfusion
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2024-02-06
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized parallel controlled study
Primary purpose: TREATMENT

Brief 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

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.

Primary outcomes:
measure: Intraoperative and postoperative allogeneic blood transfusion rate
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Number of circulating tumor cells in the blood
timeFrame: within 30 days post-surgery
measure: Incidence of transfusion related adverse reactions
timeFrame: within 14 days post-surgery
measure: occurence of new lesions
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong provincial people's hospital
state: Guangdong
Study officials:
References: