Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| H-2-2011-024 | Other Identifier | The Danish Committee on Biomedical Research Ethics | |
| 2008-41-2128 | Other Identifier | Danish Dataprotection Agency |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preoperative embolization | Experimental | 32 patients with spinal metastasis/metastases will undergo arteriography and receive transcatheter arterial embolization of spinal metastasis/metastases 0-48 hours prior to surgery. |
|
| Control group | Active Comparator | 32 patients with spinal metastasis/metastases will undergo arteriography of spinal metastasis/metastases without receiving transcatheter arterial embolization prior to surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arteriography and preoperative embolization | Procedure | Arteriography and transcatheter arterial embolization of spinal metastasis/metastases 0-48 hours prior to surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative blood loss | Measured intraoperatively and 24 hours postoperatively. |
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative blood transfusion volume | Intraoperatively and until 48 hours postoperatively. | |
| Surgical procedure time. | Defined as the amount of time (measured in minutes) from skin incision to skin closure. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lars Lönn, MD, Ph.d. | Department of Radiology, Rigshospitalet. Copenhagen, Denmark. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Radiology, Rigshospitalet | Copenhagen | 2100 | Denmark |
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D016063 | Blood Loss, Surgical |
| D013125 | Spinal Neoplasms |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007431 | Intraoperative Complications |
Not provided
Not provided
| ID | Term |
|---|---|
| D004621 | Embolization, Therapeutic |
| D002533 | Cerebral Angiography |
| ID | Term |
|---|---|
| D006489 | Hemostatic Techniques |
| D013812 | Therapeutics |
| D060205 | Therapeutic Occlusion |
| D009485 | Neuroradiography |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Arteriography | Procedure | Arteriography of spinal metastasis/metastases without transcatheter arterial embolization prior to surgery. |
|
|
| At 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 |
| D001859 | Bone Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D013122 | Spinal Diseases |
| D059906 |
| Neuroimaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D000792 | Angiography |
| D011859 | Radiography |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D003943 | Diagnostic Techniques, Neurological |
| D008919 | Investigative Techniques |