Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06244264

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?

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guangdong provincial people's hospital

Guangzhou, Guangdong, 516008, China

Location status: Recruiting

Location contact

Guoqing Zhong, M.D.

CONTACT

[email protected]

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Autoblood transfusion

Procedure

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Number of circulating tumor cells in the blood

    Time frame: within 30 days post-surgery

    Number of circulating tumor cells in the blood

  2. Incidence of transfusion related adverse reactions

    Time frame: within 14 days post-surgery

    the number of adverse reactions/ the total number of patients

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Guoqing Zhong, M.D.

CONTACT

[email protected]

8613417005047

Yu Zhang, Ph.D.

CONTACT

[email protected]

8613602744495

Sponsors and collaborators

Lead sponsor

Guangdong Provincial People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2027
First posted
Feb 6, 2024
Registry last updated
Jul 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.