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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGuangdong Provincial People's Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Autoblood transfusion

    Procedure/Surgery

    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

Treatment groups

118 Participants
are divided into 2 treatment groups
Group A: Autoblood transfusion + leukocyte filter groupExperimental treatment 1 intervention
Group B: Allogeneic blood transfusion groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Intraoperative and postoperative allogeneic blood transfusion rate

The number of allogeneic blood transfusion patients (Intraoperative or postoperative )/ the total number of patients

Time frame
Through study completion, an average of 1 year

Secondary outcomes

1

Number of circulating tumor cells in the blood

Number of circulating tumor cells in the blood

Time frame
within 30 days post-surgery
2

Incidence of transfusion related adverse reactions

the number of adverse reactions/ the total number of patients

Time frame
within 14 days post-surgery
3

occurence of new lesions

the number of patients with occurence of new lesions / the total number of patients

Time frame
through study completion, an average of 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.