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Spine tumor bleeding study halted after just 4 patients

NCT ID NCT03853434

Disease control Sponsor: Istituto Ortopedico Rizzoli Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study aimed to see if a procedure called angiographic embolization (blocking blood vessels feeding spine tumors) before surgery could reduce blood loss during the operation. It included adults aged 18-75 with spine metastases that had moderate blood supply. The study was stopped early after enrolling only 4 people, so no clear conclusions can be drawn.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

4 people

The number who actually took part.

Started

Mar 2019

Finished

Aug 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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; * indication to emergency surgery; * time between embolization and surgery\> 72 h; * refusal by the patient.

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Conditions

The condition(s) this trial relates to.

Hemorrhage metastatic malignant neoplasm in the spinal cord

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Blood loss Early goal directed therapy Embolization, therapeutic Spine metastasis

Contacts and locations

Locations

  • Giancarlo Facchini

    Bologna, 40136, Italy

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