NCT01365715

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 3, 2011

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

February 26, 2014

Status Verified

February 1, 2014

Enrollment Period

2.8 years

First QC Date

May 27, 2011

Last Update Submit

February 25, 2014

Conditions

Spinal Metastases

Keywords

Preoperative embolizationTranscatheter arterial embolizationTherapeutic angiographyEmbolizationSurgical blood lossSpinal metastasesSpinal neoplasmsVertebral metastasesmetastatic spine surgerySpinal surgery

Outcome Measures

Primary Outcomes (1)

  • Perioperative blood loss

    Measured intraoperatively and 24 hours postoperatively.

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

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.

Procedure: Arteriography and preoperative embolization

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.

Procedure: Arteriography

Interventions

Arteriography and preoperative embolizationPROCEDURE

Arteriography and transcatheter arterial embolization of spinal metastasis/metastases 0-48 hours prior to surgery.

Also known as: Transcatheter arterial embolization, Selective arterial embolization, Therapeutic angiography, Embolization
Preoperative embolization
ArteriographyPROCEDURE

Arteriography of spinal metastasis/metastases without transcatheter arterial embolization prior to surgery.

Also known as: Angiography
Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for decompression and posterior thoracic and/or lumbar instrumented spinal fusion because of spinal metastasis/metastases.
  • Informed signed consent.

You may not qualify if:

  • Contrast fluid allergy.
  • Clotting disorders.
  • Renal failure.
  • Not suitable for arterial access.
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Radiology, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Links

MeSH Terms

Conditions

Blood Loss, SurgicalSpinal Neoplasms

Interventions

Embolization, TherapeuticCerebral Angiography

Condition Hierarchy (Ancestors)

HemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsIntraoperative ComplicationsBone NeoplasmsNeoplasms by SiteNeoplasmsBone DiseasesMusculoskeletal DiseasesSpinal Diseases

Intervention Hierarchy (Ancestors)

Hemostatic TechniquesTherapeuticsTherapeutic OcclusionNeuroradiographyNeuroimagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisAngiographyRadiographyDiagnostic Techniques, CardiovascularDiagnostic Techniques, NeurologicalInvestigative Techniques

Study Officials

  • Lars Lönn, MD, Ph.d.

    Department of Radiology, Rigshospitalet. Copenhagen, Denmark.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 27, 2011

First Posted

June 3, 2011

Study Start

May 1, 2011

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

February 26, 2014

Record last verified: 2014-02

Locations

DK(1)