Preoperative Embolization in Surgical Treatment of Spinal Metastases.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Caroline Clausen, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01365715
First received: May 27, 2011
Last updated: February 25, 2014
Last verified: February 2014
  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 48 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 ]

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
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: February 25, 2014
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
Neoplasms
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on October 29, 2014