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Preoperative Embolization in Surgical Treatment of Spinal Metastases.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01365715
First Posted: June 3, 2011
Last Update Posted: February 26, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Caroline Clausen, Rigshospitalet, Denmark
  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
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Preoperative Embolization in Surgical Treatment of Spinal Metastases. A Randomized Controlled Trial.

Further study details as provided by Caroline Clausen, Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Perioperative blood loss [ Time Frame: Measured intraoperatively and 24 hours postoperatively. ]

Secondary Outcome Measures:
  • Perioperative blood transfusion volume [ Time Frame: Intraoperatively and until 48 hours postoperatively. ]
  • Surgical procedure time. [ Time Frame: At skin closure. ]
    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. ]
  • Success of embolization [ Time Frame: Directly after the embolization performed 0-48 hours before surgery. ]
  • Adverse events related to angiography or embolization [ Time Frame: Within 2 postoperative days ]
  • Adverse events related to surgery [ Time Frame: Within 2 postoperative days ]

Enrollment: 48
Study Start Date: May 2011
Study Completion Date: February 2014
Primary Completion Date: February 2014 (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:
  • Transcatheter arterial embolization
  • Selective arterial embolization
  • Therapeutic angiography
  • Embolization
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01365715


Locations
Denmark
Department of Radiology, Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Study Chair: Lars Lönn, MD, Ph.d. Department of Radiology, Rigshospitalet. Copenhagen, Denmark.
  More Information

Additional Information:
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 ( Other Identifier: The Danish Committee on Biomedical Research Ethics )
2008-41-2128 ( Other Identifier: Danish Dataprotection Agency )
First Submitted: May 27, 2011
First Posted: June 3, 2011
Last Update Posted: February 26, 2014
Last Verified: February 2014

Keywords provided by Caroline Clausen, 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