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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


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
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