Spine MetastasisEmbartNCT03853434
Efficacy of Angiographic Embolization vs Non-embolization of Moderate/Poor Vascularized Vertebral Metastases on Intraoperative Bleeding During Surgery Decompression and Vertebral Stabilization.
A study testing Embolization in people with Spine Metastasis and Early Goal Directed Therapy, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
Although angiographic embolization has been introduced for preoperative management of spine metastases in 1975 and is suggested today by many authors in the management of such pathologies, it needs to be confirmed by RCT. It is a minimally invasive procedure, not free from complications. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spine Metastasis, Early Goal Directed Therapy, Embolization, Therapeutic
- What is being tested?
- Embolization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2019to 30 Aug 2025
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male, Female aged 18 years and 75 years
- prognosis >6 months (Tokuhashi score ≤ 11)
- patients with lesions with moderate vascularization (grade 2)
- time between embolization and intervention >/= 48-72 h
Who cannot join
- congenital and iatrogenic hemocoagulative disorders (PT INR> 1.5, aPTT ratio> 1.25 with documented coagulation factor deficiency, PLT < 80,000 / microL or known coagulation pathologies);
- renal failure (creatinine ≥ 1.2);
- MDC iodized allergy;
- pregnancy / lactation;
- chronic ischemic heart disease;
- precluded arterial access by angiography;
Show all 9Show fewer
- indication to emergency surgery;
- time between embolization and surgery> 72 h;
- refusal by the patient.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Angiographic Embolization vs Non-embolization of Moderate/Poor Vascularized Vertebral Metastases on Intraoperative Bleeding During Surgery Decompression and Vertebral Stabilization. Randomized Controlled Observer- Blinded
Although angiographic embolization has been introduced for preoperative management of spine metastases in 1975 and is suggested today by many authors in the management of such pathologies, it needs to be confirmed by RCT. It is a minimally invasive procedure, not free from complications. The recent meta-analyzes, due to the limited number of patients included are not exhaustive about the effectiveness of embolization in the reduction of the intraoperative bleeding, especially in the context of poor / moderate metastasis vascularization. We want to evaluate the efficacy of preoperative angiographic embolization of intermediate / poor vascularized spine metastases in reducing intraoperative blood loss during excision surgery.
- Being tested
- Embolization
- Keywords
- embolization, blood loss, Early Goal Directed Therapy, spine metastasis
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmbolizationProcedure or surgery
Angiographic embolization
| Study group | Role | What they receive |
|---|---|---|
| Embolization | Experimental | After angiography all metastases with poor/moderate vascularization will be embolized with acrylic glue in the treatment group. Receives: Procedure: Embolization |
| No embolization | No intervention | After angiography all metastasis with poor/moderate vascularization will not be embolized with acrylic glue in the control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative blood loss
volume (ml) of intraoperative blood loss volume aspirated from operative field (ml) + differential weight gauze at the end of surgery - dry gauze weight with 1g blood conversion = 0.948ml
Measured: during procedure
Secondary outcomes (8)
Concentration of Hemoglobin pre / post-operative
Measured: 24 hours
volume of transfused blood (ml)
Measured: intraoperatively
Correlation between primary tumor and vascularization
Measured: during angiographic procedure
correlation between the type of primary tumor and blood losses
Measured: 24 hours
technical evaluation of the final result of embolization (total - 100%, subtotal 90-80% and partial 70-50%) in relation to blood losses
Measured: during angiographic procedure
evaluation of operative time, from incision to end of suture
Measured: during procedure
incidence of complications related to transfusions;
Measured: during hospitalization
duration of the hospitalization in ICU
Measured: during hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2019
- Study start1 Mar 2019
- Primary completion30 Aug 2025
- Study completion30 Aug 2025
Why it stopped: Difficulties in recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine MetastasisStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe 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
- Investigator
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03853434
- Sponsor's protocol ID
- Embart
- Acronym
- Embart
- Status last verified
- May 2026
- First submitted
- 15 Jan 2019
- Last updated
- 22 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Angiographic Embolization vs Non-embolization of Moderate/Poor Vascularized Vertebral Metastases on Intraoperative Bleeding During Surgery Decompression and Vertebral Stabilization. Randomized Controlled Observer- Blinded
- ClinicalTrials.gov ID
- NCT03853434
- Acronym / sponsor ID
- Embart / Embart
- Keywords
- embolization, blood loss, Early Goal Directed Therapy, spine metastasis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties in recruitment.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 25 Feb 2019 (actual)
- 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.
Although angiographic embolization has been introduced for preoperative management of spine metastases in 1975 and is suggested today by many authors in the management of such pathologies, it needs to be confirmed by RCT. It is a minimally invasive procedure, not free from complications. The recent meta-analyzes, due to the limited number of patients included are not exhaustive about the effectiveness of embolization in the reduction of the intraoperative bleeding, especially in the context of poor / moderate metastasis vascularization. We want to evaluate the efficacy of preoperative angiographic embolization of intermediate / poor vascularized spine metastases in reducing intraoperative blood loss during excision surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Embolization | Experimental | Procedure: EmbolizationAfter angiography all metastases with poor/moderate vascularization will be embolized with acrylic glue in the treatment group. |
| No embolization | No intervention | –After angiography all metastasis with poor/moderate vascularization will not be embolized with acrylic glue in the control group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male, Female aged 18 years and 75 years
- prognosis >6 months (Tokuhashi score ≤ 11)
- patients with lesions with moderate vascularization (grade 2)
- time between embolization and intervention >/= 48-72 h
Key exclusion criteria (9 listed)
- congenital and iatrogenic hemocoagulative disorders (PT INR> 1.5, aPTT ratio> 1.25 with documented coagulation factor deficiency, PLT < 80,000 / microL or known coagulation pathologies);
- renal failure (creatinine ≥ 1.2);
- MDC iodized allergy;
- pregnancy / lactation;
- chronic ischemic heart disease;
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 |
|---|---|---|
| EmbolizationAngiographic embolization | Procedure or surgery | Embolization |
Primary outcome
Intraoperative blood loss
Time frame: during procedure
volume (ml) of intraoperative blood loss volume aspirated from operative field (ml) + differential weight gauze at the end of surgery - dry gauze weight with 1g blood conversion = 0.948ml
8 secondary outcomes
Concentration of Hemoglobin pre / post-operative
Time frame: 24 hours
volume of transfused blood (ml)
Time frame: intraoperatively
Correlation between primary tumor and vascularization
Time frame: during angiographic procedure
correlation between the type of primary tumor and blood losses
Time frame: 24 hours
technical evaluation of the final result of embolization (total - 100%, subtotal 90-80% and partial 70-50%) in relation to blood losses
Time frame: during angiographic procedure
evaluation of operative time, from incision to end of suture
Time frame: during procedure
incidence of complications related to transfusions;
Time frame: during hospitalization
duration of the hospitalization in ICU
Time frame: during hospitalization
Results and safety
The study was stopped early (reason given: Difficulties in recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Embolization in people with Spine Metastasis and Early Goal Directed Therapy, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
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 4 inclusion and 9 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: stopped early, as of the sponsor's last update on 22 May 2026. 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 Italy. 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 was stopped early (reason given: Difficulties in recruitment.). Results are not available in the source record.
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?
Intraoperative blood loss (time frame: during procedure). 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 22 May 2026.