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Clinical Trials/NCT01365715
NCT01365715
Completed
Not Applicable

Preoperative Embolization in Surgical Treatment of Spinal Metastases. A Randomized Controlled Trial.

Rigshospitalet, Denmark1 site in 1 country48 target enrollmentMay 2011
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ConditionsSpinal Metastases

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Spinal Metastases
Sponsor
Rigshospitalet, Denmark
Enrollment
48
Locations
1
Primary Endpoint
Perioperative blood loss
Status
Completed
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
May 2011
End Date
February 2014
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Caroline Clausen

MD

Rigshospitalet, Denmark

Eligibility 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.

Outcomes

Primary Outcomes

Perioperative blood loss

Time Frame: Measured intraoperatively and 24 hours postoperatively.

Secondary Outcomes

  • Perioperative blood transfusion volume(Intraoperatively and until 48 hours postoperatively.)
  • Surgical procedure time.(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)

Study Sites (1)

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