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

NCT06244264 | Recruiting DMC

• 1 other identifier: SPMAT001
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

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

  Through study completion, an average of 1 year

Secondary Outcomes (3)

• Number of circulating tumor cells in the blood

  within 30 days post-surgery

• Incidence of transfusion related adverse reactions

  within 14 days post-surgery

• occurence of new lesions

  through study completion, an average of 1 year

Study Arms (2)

Autoblood transfusion + leukocyte filter group

EXPERIMENTAL

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

Allogeneic blood transfusion group

NO INTERVENTION

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.

Interventions

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

Autoblood transfusion + leukocyte filter group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Study Sites (1)

Guangdong provincial people's hospital

Guangzhou, Guangdong, 516008, China

RECRUITING

MeSH Terms

Conditions

Transfusion Reaction; Lung Neoplasms

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Immune System Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Yu Zhang, Ph.D.

CONTACT

8613602744495; luck_2001@126.com

Guoqing Zhong, M.D.

CONTACT

8613417005047; gqzhong@foxmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Orthopedic Oncology

Model Details: randomized parallel controlled study

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: February 6, 2024
• Study Start: March 15, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 12, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)