Preoperative Embolization in Surgical Treatment of Spinal Metastases.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2014-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Spinal Metastases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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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.

Group Type EXPERIMENTAL

Arteriography and preoperative embolization

Intervention Type PROCEDURE

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

Control group

32 patients with spinal metastasis/metastases will undergo arteriography of spinal metastasis/metastases without receiving transcatheter arterial embolization prior to surgery.

Group Type ACTIVE_COMPARATOR

Arteriography

Intervention Type PROCEDURE

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

Interventions

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Arteriography and preoperative embolization

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

Intervention Type PROCEDURE

Arteriography

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

Intervention Type PROCEDURE

Other Intervention Names

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Transcatheter arterial embolization Selective arterial embolization Therapeutic angiography Embolization Angiography

Eligibility Criteria

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Inclusion Criteria

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