Spinal MetastasesNCT01365715
Preoperative Embolization in Surgical Treatment of Spinal Metastases.
A study testing Arteriography and preoperative embolization and Arteriography in people with Spinal Metastases, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Metastases
- What is being tested?
- Arteriography and preoperative embolization and Arteriography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteDenmark
- Study dates
- May 2011to Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for decompression and posterior thoracic and/or lumbar instrumented spinal fusion because of spinal metastasis/metastases.
- Informed signed consent.
Who cannot join
- Contrast fluid allergy.
- Clotting disorders.
- Renal failure.
- Not suitable for arterial access.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preoperative Embolization in Surgical Treatment of Spinal Metastases. A Randomized Controlled Trial.
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.
- Conditions
- Spinal Metastases
- Being tested
- Arteriography and preoperative embolization, Arteriography
- Keywords
- Preoperative embolization, Transcatheter arterial embolization, Therapeutic angiography, Embolization, Surgical blood loss, Spinal metastases, Spinal neoplasms, Vertebral metastases, metastatic spine surgery, Spinal surgery
- Medical subject headings
- Blood Loss, Surgical, Spinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arteriography and preoperative embolizationProcedure or surgery
Also called Transcatheter arterial embolization, Selective arterial embolization, Therapeutic angiography, Embolization
Arteriography and transcatheter arterial embolization of spinal metastasis/metastases 0-48 hours prior to surgery.
ArteriographyProcedure or surgery
Also called Angiography
Arteriography of spinal metastasis/metastases without transcatheter arterial embolization prior to surgery.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative embolization | Experimental | 32 patients with spinal metastasis/metastases will undergo arteriography and receive transcatheter arterial embolization of spinal metastasis/metastases 0-48 hours prior to surgery. Receives: Procedure: Arteriography and preoperative embolization |
| Control group | Active comparator | 32 patients with spinal metastasis/metastases will undergo arteriography of spinal metastasis/metastases without receiving transcatheter arterial embolization prior to surgery. Receives: Procedure: Arteriography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative blood loss
Measured: Measured intraoperatively and 24 hours postoperatively.
Secondary outcomes (6)
Perioperative blood transfusion volume
Measured: Intraoperatively and until 48 hours postoperatively.
Surgical procedure time.
Defined as the amount of time (measured in minutes) from skin incision to skin closure.
Measured: At skin closure.
Vascularization grade of metastasis
Measured: At the angiographic procedure prior to embolization performed 0-48 hours before surgery.
Success of embolization
Measured: Directly after the embolization performed 0-48 hours before surgery.
Adverse events related to angiography or embolization
Measured: Within 2 postoperative days
Adverse events related to surgery
Measured: Within 2 postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2011 (estimated)
- Study startMay 2011
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal MetastasesStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caroline Clausen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Lars Lönn, MD, Ph.d., Study chair, Department of Radiology, Rigshospitalet. Copenhagen, Denmark.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01365715
- Sponsor's protocol ID
- H-2-2011-024
- Other IDs
- H-2-2011-024, 2008-41-2128
- Status last verified
- Feb 2014
- First submitted
- 27 May 2011
- Last updated
- 26 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Embolization in Surgical Treatment of Spinal Metastases. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01365715
- Acronym / sponsor ID
- H-2-2011-024
- Conditions
- Spinal Metastases
- Keywords
- Preoperative embolization, Transcatheter arterial embolization, Therapeutic angiography, Embolization, Surgical blood loss, Spinal metastases, Spinal neoplasms, Vertebral metastases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 3 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preoperative embolization | Experimental | Procedure: Arteriography and preoperative embolization32 patients with spinal metastasis/metastases will undergo arteriography and receive transcatheter arterial embolization of spinal metastasis/metastases 0-48 hours prior to surgery. |
| Control group | Active comparator | Procedure: Arteriography32 patients with spinal metastasis/metastases will undergo arteriography of spinal metastasis/metastases without receiving transcatheter arterial embolization prior to surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled for decompression and posterior thoracic and/or lumbar instrumented spinal fusion because of spinal metastasis/metastases.
- Informed signed consent.
Key exclusion criteria (5 listed)
- Contrast fluid allergy.
- Clotting disorders.
- Renal failure.
- Not suitable for arterial access.
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arteriography and preoperative embolizationAlso: Transcatheter arterial embolization, Selective arterial embolization, Therapeutic angiography, EmbolizationArteriography and transcatheter arterial embolization of spinal metastasis/metastases 0-48 hours prior to surgery. | Procedure or surgery | Preoperative embolization |
| ArteriographyAlso: AngiographyArteriography of spinal metastasis/metastases without transcatheter arterial embolization prior to surgery. | Procedure or surgery | Control group |
Primary outcome
Perioperative blood loss
Time frame: Measured intraoperatively and 24 hours postoperatively.
6 secondary outcomes
Perioperative blood transfusion volume
Time frame: Intraoperatively and until 48 hours postoperatively.
Surgical procedure time.
Time frame: At skin closure.
Vascularization grade of metastasis
Time frame: At the angiographic procedure prior to embolization performed 0-48 hours before surgery.
Success of embolization
Time frame: Directly after the embolization performed 0-48 hours before surgery.
Adverse events related to angiography or embolization
Time frame: Within 2 postoperative days
Adverse events related to surgery
Time frame: Within 2 postoperative days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2014.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars Lönn, MD, Ph.d. study chair
Department of Radiology, Rigshospitalet. Copenhagen, Denmark.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arteriography and preoperative embolization and Arteriography in people with Spinal Metastases, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative blood loss (time frame: Measured intraoperatively and 24 hours postoperatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2014.