Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID06244264

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

Led by Guangdong Provincial People's Hospital · Updated on 2024-07-12

118

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of autologous blood transfusion in spinal surgery for patients with lung cancer that has spread to the spine. This study aims to find out if autologous blood transfusion increases new metastases, affects postoperative hemoglobin levels and circulating tumor cells, and reduces the need for allogeneic blood transfusions during and after surgery. This is a single-center, prospective, randomized controlled trial focused on lung cancer spinal metastases. Participants will undergo standard open spinal decompression surgery. When blood transfusion is needed during surgery, patients will receive either autologous blood transfusion combined with a leukocyte filter or allogeneic blood transfusion. Autologous transfusion involves collecting and filtering the patient's own blood lost during surgery, washing and concentrating red blood cells, and then transfusing them back. Blood transfusion decisions depend on bleeding during surgery. The study groups are compared to observe differences in transfusion rates, circulating tumor cells, new metastases, and costs. During the study, researchers will monitor the rate of allogeneic blood transfusion during and after surgery over about one year. They will also measure the number of circulating tumor cells within 30 days after surgery and observe any transfusion-related adverse reactions within 14 days post-surgery. Participants will have assessments of hemoglobin levels and new lesion occurrence. The study lasts on average one year from surgery, with detailed laboratory tests including flow cytometry and tumor cell culture to assess blood samples before and after transfusion.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 75 years old
  • Pathological diagnosis of lung cancer and spinal metastatic tumor
  • Expected survival longer than 3 months and able to tolerate surgery
  • Unstable spine and/or spinal cord nerve compression with progressive decline in nerve function
  • Planned palliative open spinal decompression surgery
  • Patients with intraoperative or postoperative hemoglobin less than 90 g/L or other conditions requiring blood transfusion
Not Eligible

You will not qualify if you...

  • Serious heart dysfunction or heart failure
  • Blood system diseases or coagulation disorders
  • Severe renal insufficiency or need for hemodialysis treatment
  • Sepsis or septicemia
  • Unable to obtain consent from the patient or family

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Surgery day and immediate post-operative period

Participants undergo open spinal decompression surgery. During surgery, blood transfusion is provided as needed using either autologous blood transfusion combined with a leukocyte filter or allogeneic blood transfusion based on bleeding.

1 surgical visit and hospital stay

Follow-up

Duration - Up to 1 year post-surgery

Participants are monitored for postoperative hemoglobin levels, circulating tumor cells in the blood, transfusion-related adverse reactions, and the occurrence of new metastases.

Approximately 6 to 12 follow-up visits over 1 year

Trial Site Locations

Total: 1 location

1

Guangdong provincial people's hospital

Guangzhou, Guangdong, China, 516008

Actively Recruiting

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Research Team

Y

Yu Zhang, Ph.D.

G

Guoqing Zhong, M.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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