Preoperative Embolization in Surgical Treatment of Spinal Metastases.
This study is currently recruiting participants.
Verified May 2013 by Rigshospitalet, Denmark
Sponsor:
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Caroline Clausen, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01365715
First received: May 27, 2011
Last updated: May 15, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Spinal Metastases |
Procedure: Arteriography and preoperative embolization Procedure: Arteriography |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Caregiver) Primary Purpose: Treatment |
| Official Title: | Preoperative Embolization in Surgical Treatment of Spinal Metastases. A Randomized Controlled Trial. |
Resource links provided by NLM:
Further study details as provided by Rigshospitalet, Denmark:
Primary Outcome Measures:
- Perioperative blood loss [ Time Frame: Measured intraoperatively and 24 hours postoperatively. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Perioperative blood transfusion volume [ Time Frame: Intraoperatively and until 24 hours postoperatively. ] [ Designated as safety issue: No ]
- Surgical procedure time. [ Time Frame: At skin closure. ] [ Designated as safety issue: No ]Defined as the amount of time (measured in minutes) from skin incision to skin closure.
- Vascularization grade of metastasis [ Time Frame: At the angiographic procedure prior to embolization performed 0-48 hours before surgery. ] [ Designated as safety issue: No ]
- Success of embolization [ Time Frame: Directly after the embolization performed 0-48 hours before surgery. ] [ Designated as safety issue: No ]
- Adverse events related to angiography or embolization [ Time Frame: Within 2 postoperative days ] [ Designated as safety issue: No ]
- Adverse events related to surgery [ Time Frame: Within 2 postoperative days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 64 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Preoperative embolization
32 patients with spinal metastasis/metastases will undergo arteriography and receive transcatheter arterial embolization of spinal metastasis/metastases 0-48 hours prior to surgery.
|
Procedure: Arteriography and preoperative embolization
Arteriography and transcatheter arterial embolization of spinal metastasis/metastases 0-48 hours prior to surgery.
Other Names:
|
|
Active Comparator: Control group
32 patients with spinal metastasis/metastases will undergo arteriography of spinal metastasis/metastases without receiving transcatheter arterial embolization prior to surgery.
|
Procedure: Arteriography
Arteriography of spinal metastasis/metastases without transcatheter arterial embolization prior to surgery.
Other Name: Angiography
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01365715
Contacts
| Contact: Caroline Clausen, MD | +4535458588 | clausen.caroline@gmail.com |
| Contact: Lars Lönn, MD, Ph.d. | ++4535450730 | lars.loenn@rh.regionh.dk |
Locations
| Denmark | |
| Department of Radiology, Rigshospitalet | Recruiting |
| Copenhagen, Denmark, 2100 | |
| Contact: Caroline Clausen, MD +4535458588 clausen.caroline@gmail.com | |
| Contact: Lars Lönn, MD, Ph.d. +4535450730 lars.loenn@rh.regionh.dk | |
| Principal Investigator: Caroline Clausen, MD | |
| Sub-Investigator: Lars Lönn, MD, Ph.d. | |
| Sub-Investigator: Benny Dahl, MD, D.M.Sc | |
| Sub-Investigator: Susanne C. Frevert, MD | |
| Sub-Investigator: Michael B. Nielsen, MD, D.M.Sc | |
| Sub-Investigator: Lars Valentin, MD | |
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
| Study Chair: | Lars Lönn, MD, Ph.d. | Department of Radiology, Rigshospitalet. Copenhagen, Denmark. |
More Information
Additional Information:
No publications provided
| Responsible Party: | Caroline Clausen, MD, Rigshospitalet, Denmark |
| ClinicalTrials.gov Identifier: | NCT01365715 History of Changes |
| Other Study ID Numbers: | H-2-2011-024, H-2-2011-024, 2008-41-2128 |
| Study First Received: | May 27, 2011 |
| Last Updated: | May 15, 2013 |
| Health Authority: | Denmark: The Danish National Committee on Biomedical Research Ethics Denmark: Danish Dataprotection Agency |
Keywords provided by Rigshospitalet, Denmark:
|
Preoperative embolization Transcatheter arterial embolization Therapeutic angiography Embolization Surgical blood loss |
Spinal metastases Spinal neoplasms Vertebral metastases metastatic spine surgery Spinal surgery |
Additional relevant MeSH terms:
|
Neoplasm Metastasis Neoplasms, Second Primary Neoplastic Processes Neoplasms Pathologic Processes |
ClinicalTrials.gov processed this record on May 21, 2013