Preoperative Embolization in Surgical Treatment of Spinal Metastases.

Spinal Metastases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01365715
• Other study ID #: H-2-2011-024
• Secondary ID: H-2-2011-0242008
• Status: Completed
• Phase: N/A
• First received: May 27, 2011
• Last updated: February 25, 2014
• Start date: May 2011
• Est. completion date: February 2014

Study information

• Verified date: February 2014
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Spinal Metastases

Intervention

Procedure:
• Arteriography and preoperative embolization
Arteriography and transcatheter arterial embolization of spinal metastasis/metastases 0-48 hours prior to surgery.
• Arteriography
Arteriography of spinal metastasis/metastases without transcatheter arterial embolization prior to surgery.

Locations

Country	Name	City	State
Denmark	Department of Radiology, Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perioperative blood loss		Measured intraoperatively and 24 hours postoperatively.	No
Secondary	Perioperative blood transfusion volume		Intraoperatively and until 48 hours postoperatively.	No
Secondary	Surgical procedure time.	Defined as the amount of time (measured in minutes) from skin incision to skin closure.	At skin closure.	No
Secondary	Vascularization grade of metastasis		At the angiographic procedure prior to embolization performed 0-48 hours before surgery.	No
Secondary	Success of embolization		Directly after the embolization performed 0-48 hours before surgery.	No
Secondary	Adverse events related to angiography or embolization		Within 2 postoperative days	No
Secondary	Adverse events related to surgery		Within 2 postoperative days	No

External Links

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