Preoperative Embolization in Surgical Treatment of Spinal Metastases.

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01365715

Enrollment

Registered

2011-06-03

Start date

2011-05-31

Completion date

2014-02-28

Last updated

2014-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Metastases

Keywords

Preoperative embolization, Transcatheter arterial embolization, Therapeutic angiography, Embolization, Surgical blood loss, Spinal metastases, Spinal neoplasms, Vertebral metastases, metastatic spine surgery, Spinal surgery

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.

Interventions

PROCEDUREArteriography and preoperative embolization

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

PROCEDUREArteriography

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Perioperative blood loss	Measured intraoperatively and 24 hours postoperatively.

Secondary

Measure	Time frame	Description
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.	—
Perioperative blood transfusion volume	Intraoperatively and until 48 hours postoperatively.	—
Adverse events related to angiography or embolization	Within 2 postoperative days	—
Adverse events related to surgery	Within 2 postoperative days	—
Success of embolization	Directly after the embolization performed 0-48 hours before surgery.	—

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026