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Recruiting Not applicable

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

NCT06244264 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2024-03-15
Last updated
2024-07-12

Condition(s) studied

Spinal MetastasesBlood Transfusion ComplicationLung CancerSurgeryAutologous Blood Transfusion

Investigational drug(s) / intervention(s)

Autoblood transfusion

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

Study 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?

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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 outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
Guangdong provincial people's hospital Guangzhou Guangdong Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06244264 on ClinicalTrials.gov ↗ ← All trials in China