Comparing embolization and non-embolization for reducing blood loss in spine surgery for metastases
Efficacy of Angiographic Embolization vs Non-embolization of Moderate/Poor Vascularized Vertebral Metastases on Intraoperative Bleeding During Surgery Decompression and Vertebral Stabilization. Randomized Controlled Observer- Blinded
NA · Istituto Ortopedico Rizzoli · NCT03853434
This study is testing if a procedure called embolization can help reduce bleeding during spine surgery for patients with certain types of cancer in their vertebrae.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Istituto Ortopedico Rizzoli (other) |
| Locations | 1 site (Bologna) |
| Trial ID | NCT03853434 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of preoperative angiographic embolization in reducing intraoperative blood loss during surgery for patients with moderate to poorly vascularized vertebral metastases. The study will involve patients aged 18 to 75 years who have a prognosis of more than six months and specific vascularization criteria for their lesions. By comparing outcomes between those who undergo embolization and those who do not, the trial seeks to provide clearer evidence on the benefits of this minimally invasive procedure in surgical settings.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with moderate vascularization of spine metastases and a prognosis of over six months.
Not a fit: Patients with coagulation disorders, renal failure, or those requiring emergency surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced blood loss for patients undergoing surgery for spine metastases.
How similar studies have performed: Previous studies have suggested potential benefits of embolization, but this trial aims to provide definitive evidence through a randomized controlled approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bologna
- Giancarlo Facchini — Bologna, Italy (RECRUITING)
Study contacts
- Study coordinator: Giancarlo Facchini
- Email: giancarlo.facchini@ior.it
- Phone: 3336500944
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.
Conditions: Spine Metastasis, Early Goal Directed Therapy, Embolization, Therapeutic, Blood Loss, embolization, blood loss, spine metastasis