The Safety and Efficacy of Autologous Transfusion in Spinal Surgery for Lung Cancer With Spinal Metastasis
NCT06244264 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 118
Last updated 2024-07-12
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?
Conditions
- Spinal Metastases
- Blood Transfusion Complication
- Lung Cancer
- Surgery
- Autologous Blood Transfusion
Interventions
- 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
Sponsors & Collaborators
-
Guangdong Provincial People's Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-03-15
- Primary Completion
- 2025-12-31
- Completion
- 2027-12-31
Countries
- China
Study Locations
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