The Safety and Efficacy of Autologous Transfusion in Spinal Surgery for Lung Cancer With Spinal Metastasis
- Conditions
- Spinal MetastasesSurgeryLung CancerBlood Transfusion ComplicationAutologous Blood Transfusion
- Interventions
- Procedure: Autoblood transfusion
- Registration Number
- NCT06244264
- Lead Sponsor
- Guangdong Provincial People's Hospital
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 118
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Autoblood transfusion + leukocyte filter group Autoblood transfusion 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.
- Primary Outcome Measures
Name Time Method Intraoperative and postoperative allogeneic blood transfusion rate Through study completion, an average of 1 year The number of allogeneic blood transfusion patients (Intraoperative or postoperative )/ the total number of patients
- Secondary Outcome Measures
Name Time Method Incidence of transfusion related adverse reactions within 14 days post-surgery the number of adverse reactions/ the total number of patients
occurence of new lesions through study completion, an average of 1 year the number of patients with occurence of new lesions / the total number of patients
Number of circulating tumor cells in the blood within 30 days post-surgery Number of circulating tumor cells in the blood
Trial Locations
- Locations (1)
Guangdong provincial people's hospital
🇨🇳Guangzhou, Guangdong, China