Preoperative Embolization in Surgical Treatment of Spinal Metastases.

Rigshospitalet

Status: Completed

Conditions: Spinal Metastases

Treatments: Procedure: Arteriography and preoperative embolization; Procedure: Arteriography

Study type: Interventional

Funder types: Other

Identifiers

NCT01365715

H-2-2011-024 (Other Identifier)

2008-41-2128 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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48 participants in 2 patient groups

Preoperative embolization

Experimental group

Description:

32 patients with spinal metastasis/metastases will undergo arteriography and receive transcatheter arterial embolization of spinal metastasis/metastases 0-48 hours prior to surgery.

Treatment:

Procedure: Arteriography and preoperative embolization

Control group

Active Comparator group

Description:

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

Treatment:

Procedure: Arteriography