Efficacy of Angiographic Embolization vs Non-embolization of Moderate/Poor Vascularized Vertebral Metastases on Intraoperative Bleeding During Surgery Decompression and Vertebral Stabilization.

Launched by ISTITUTO ORTOPEDICO RIZZOLI · Feb 22, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a medical procedure called angiographic embolization, which is used to reduce bleeding during surgery for patients with spine metastases, or cancer that has spread to the spine. The goal of the research is to see if this procedure, done before surgery, can help decrease blood loss in patients whose tumors have moderate to poor blood supply. Even though this technique has been used since 1975, the researchers want to confirm its effectiveness through this trial.

To participate in the trial, individuals must be between 18 and 75 years old and have a life expectancy of more than six months. They should have tumors that are classified as having moderate blood supply. However, certain conditions may exclude someone from joining, such as bleeding disorders, severe kidney problems, or being pregnant. If eligible, participants will undergo the embolization procedure followed by surgery to remove the tumor, and they will be monitored to see how much blood loss occurs during the operation. This trial is currently recruiting participants, and it aims to provide important information about the safety and effectiveness of this treatment method.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male, Female aged 18 years and 75 years
• • prognosis \>6 months (Tokuhashi score ≤ 11)
• • patients with lesions with moderate vascularization (grade 2)
• • time between embolization and intervention \>/= 48-72 h
• Exclusion Criteria:
• • congenital and iatrogenic hemocoagulative disorders (PT INR\> 1.5, aPTT ratio\> 1.25 with documented coagulation factor deficiency, PLT \< 80,000 / microL or known coagulation pathologies);
• • renal failure (creatinine ≥ 1.2);
• • MDC iodized allergy;
• • pregnancy / lactation;
• • chronic ischemic heart disease;
• • precluded arterial access by angiography;
• • indication to emergency surgery;
• • time between embolization and surgery\> 72 h;
• • refusal by the patient.