Preoperative Embolization in Surgical Treatment of Spinal Metastases.

Not Applicable

Completed

• Conditions: Spinal Metastases
• Interventions: Procedure: Arteriography and preoperative embolization; Procedure: Arteriography

• Registration Number: NCT01365715
• Lead Sponsor: Rigshospitalet, Denmark

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-27
• Study First Submitted QC: 2011-06-01
• Study First Posted: 2011-06-03
• Status Verified: 2014-02
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Last Update Submitted: 2014-02-25
• Last Update Posted: 2014-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Preoperative embolization	Arteriography and 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.
Control group	Arteriography	32 patients with spinal metastasis/metastases will undergo arteriography of spinal metastasis/metastases without receiving transcatheter arterial embolization prior to surgery.

Primary Outcome Measures

Name	Time	Method
Perioperative blood loss	Measured intraoperatively and 24 hours postoperatively.

Secondary Outcome Measures

Name	Time	Method
Perioperative blood transfusion volume	Intraoperatively and until 48 hours postoperatively.
Surgical procedure time.	At skin closure.	Defined as the amount of time (measured in minutes) from skin incision to 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

Trial Locations

Locations (1)

Department of Radiology, Rigshospitalet; 🇩🇰 Copenhagen, Denmark