Spinal Metastases Clinical Trial
Official title:
Preoperative Embolization in Surgical Treatment of Spinal Metastases. A Randomized Controlled Trial.
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.
Status | Completed |
Enrollment | 48 |
Est. completion date | February 2014 |
Est. primary completion date | February 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Radiology, Rigshospitalet | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Perioperative blood loss | Measured intraoperatively and 24 hours postoperatively. | No | |
Secondary | Perioperative blood transfusion volume | Intraoperatively and until 48 hours postoperatively. | No | |
Secondary | Surgical procedure time. | Defined as the amount of time (measured in minutes) from skin incision to skin closure. | At skin closure. | No |
Secondary | Vascularization grade of metastasis | At the angiographic procedure prior to embolization performed 0-48 hours before surgery. | No | |
Secondary | Success of embolization | Directly after the embolization performed 0-48 hours before surgery. | No | |
Secondary | Adverse events related to angiography or embolization | Within 2 postoperative days | No | |
Secondary | Adverse events related to surgery | Within 2 postoperative days | No |
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