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Completed

NCT Number: NCT01365715

Preoperative Embolization in Surgical Treatment of Spinal Metastases.

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.

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Key information

Conditions

Spinal Metastases Blood Loss, Surgical Bone Diseases Bone Neoplasms Hemorrhage Intraoperative Complications Musculoskeletal Diseases Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Spinal Diseases Spinal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Radiology, Rigshospitalet

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Arteriography and preoperative embolization

Procedure

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

Other names: Transcatheter arterial embolization, Selective arterial embolization, Therapeutic angiography, Embolization

Arteriography

Procedure

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

Other names: Angiography

Primary outcomes

  1. Perioperative blood loss

    Time frame: Measured intraoperatively and 24 hours postoperatively.

Secondary outcomes

  1. Perioperative blood transfusion volume

    Time frame: Intraoperatively and until 48 hours postoperatively.

  2. Surgical procedure time.

    Time frame: At skin closure.

    Defined as the amount of time (measured in minutes) from skin incision to skin closure.

  3. Vascularization grade of metastasis

    Time frame: At the angiographic procedure prior to embolization performed 0-48 hours before surgery.

  4. Success of embolization

    Time frame: Directly after the embolization performed 0-48 hours before surgery.

  5. Adverse events related to angiography or embolization

    Time frame: Within 2 postoperative days

  6. Adverse events related to surgery

    Time frame: Within 2 postoperative days

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jun 3, 2011
Registry last updated
Feb 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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