Evaluating autologous blood transfusion in spinal surgery for lung cancer with spinal metastasis
A Single-center, Prospective, Randomized Controlled Study of the Safety and Efficacy of Autologous Transfusion in Spinal Surgery for Lung Cancer With Spinal Metastasis
This study is testing whether using a patient's own blood during spinal surgery for lung cancer with spinal metastases is safer and more effective than using donated blood.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 118 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Guangdong Provincial People's Hospital Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06244264 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the safety and efficacy of autologous blood transfusion during spinal surgery for patients with lung cancer spinal metastases. Participants will be randomly assigned to receive either autologous or allogeneic blood transfusions during standard open spinal decompression surgery. The study will measure various outcomes, including the incidence of new metastases, postoperative hemoglobin levels, circulating tumor cells, and the rate of allogeneic transfusions. Advanced techniques such as flow cytometry and immunohistochemistry will be employed to analyze blood samples before and after transfusion.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with lung cancer and spinal metastases who can tolerate surgery and have a life expectancy of more than three months.
Not a fit: Patients with serious heart dysfunction, severe renal insufficiency, or those unable to provide consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced complications for patients undergoing spinal surgery for lung cancer.
How similar studies have performed: While the approach of using autologous transfusion in surgical settings has been explored, this specific application in lung cancer spinal metastases is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Guangzhou, Guangdong
- Guangdong provincial people's hospital — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Yu Zhang, Ph.D.
- Email: luck_2001@126.com
- Phone: 8613602744495
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.