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

July 11, 2024 updated by: Yu Zhang, PhD, Guangdong Provincial People's Hospital

A Single-center, Prospective, Randomized Controlled Study of the Safety and Efficacy of Autologous Transfusion in Spinal Surgery for Lung Cancer With Spinal Metastasis

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?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

118

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 516008
        • Recruiting
        • Guangdong Provincial People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Autoblood transfusion + leukocyte filter group
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.
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
No Intervention: Allogeneic blood transfusion group
In our department open surgery is considered as the standard procedure. The patients receives open surgery with allogeneic blood transfusion. Blood transfusion based on bleeding during surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative and postoperative allogeneic blood transfusion rate
Time Frame: Through study completion, an average of 1 year
The number of allogeneic blood transfusion patients (Intraoperative or postoperative )/ the total number of patients
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of circulating tumor cells in the blood
Time Frame: within 30 days post-surgery
Number of circulating tumor cells in the blood
within 30 days post-surgery
Incidence of transfusion related adverse reactions
Time Frame: within 14 days post-surgery
the number of adverse reactions/ the total number of patients
within 14 days post-surgery
occurence of new lesions
Time Frame: through study completion, an average of 1 year
the number of patients with occurence of new lesions / the total number of patients
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Provincial People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

January 15, 2024

First Submitted That Met QC Criteria

January 28, 2024

First Posted (Actual)

February 6, 2024

Study Record Updates

Last Update Posted (Actual)

July 12, 2024

Last Update Submitted That Met QC Criteria

July 11, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPMAT001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

After the research is completed, the data may be publicly shared depending on the outcome.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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