Preoperative Embolization in Surgical Treatment of Spinal Metastases.
Not Applicable
Completed
- Conditions
- Spinal Metastases
- Registration Number
- NCT01365715
- Lead Sponsor
- Rigshospitalet, Denmark
- Brief Summary
The main purpose of this study is to assess the efficacy of preoperative embolization in decreasing operative blood loss, decreasing the need for intraoperative transfusion and facilitate surgical resection in metastatic spine surgery. Furthermore the study aims at describing the vascularity in a series of spinal metastasis, and to correlate this with perioperative blood loss.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
Inclusion Criteria
- Patients scheduled for decompression and posterior thoracic and/or lumbar instrumented spinal fusion because of spinal metastasis/metastases.
- Informed signed consent.
Exclusion Criteria
- Contrast fluid allergy.
- Clotting disorders.
- Renal failure.
- Not suitable for arterial access.
- Pregnancy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Perioperative blood loss Measured intraoperatively and 24 hours postoperatively.
- Secondary Outcome Measures
Name Time Method Perioperative blood transfusion volume Intraoperatively and until 48 hours postoperatively. Surgical procedure time. At skin closure. Defined as the amount of time (measured in minutes) from skin incision to skin closure.
Vascularization grade of metastasis At the angiographic procedure prior to embolization performed 0-48 hours before surgery. Success of embolization Directly after the embolization performed 0-48 hours before surgery. Adverse events related to angiography or embolization Within 2 postoperative days Adverse events related to surgery Within 2 postoperative days
Trial Locations
- Locations (1)
Department of Radiology, Rigshospitalet
🇩🇰Copenhagen, Denmark
Department of Radiology, Rigshospitalet🇩🇰Copenhagen, Denmark