An observational study in Hemorrhage, Gastrointestinal Hemorrhage and Hemoptysis, sponsored by Aesculap AG. Not yet recruiting at 11 sites in Japan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Aesculap AG (part of B. Braun) · Observational
This observational study will collect information from adult patients in Japan who are treated with Histoacryl® to stop bleeding from arteries in the chest or abdomen, in order to better understand how well the treatment works and how safe it is during routine medical care.
TAB includes arterial bleeding of various causes. Untreated bleeding can lead to hemorrhagic shock and organ failure. Transcatheterial arterial embolization is an established treatment option. NBCA is an effective liquid embolizing agent.
1,383 studies on the registry are indexed under Hemorrhage; 244 are open to participants now.
This study's planned enrollment of 176 is below the median of 215 across 397 observational studies indexed under Hemorrhage.
Browse Hemorrhage studies →Aesculap AG is the lead sponsor of 105 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adults with active thoracoabdominal arterial bleeding requiring endovascular embolization will be enrolled at approximately 11 centers in Japan. Eligible patients must be scheduled to undergo embolization with Histoacryl® according to routine clinical practice and within the approved indication in Japan. The study population is expected to include patients with bleeding of various etiologies, including traumatic, iatrogenic, gastrointestinal, pulmonary (hemoptysis), obstetric, neoplastic, or other thoracoabdominal arterial hemorrhages.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients, treated with Histoacryl® for embolization after bleeding
Device: Embolization therapy
Embolization of Thoracoabdominal Artery Bleeding (TAB), excluding "Cardiac blood vessels other than Pulmonary artery", "Endoscopic esophageal varices embolization operations", and "Pulmonary artery malformation".
Clinical Success at 1 Month After Histoacryl® Embolization
Clinical success is defined as absence of bleeding from the target location after embolization with Histoacryl® without need for re-embolization or other re-interventions of the target lesion due to persistent or recurrent hemorrhage. Assessment performed on a per-patient basis.
Time frame: 30 ± 10 days after index embolization procedure
Technical Success of Embolarization
Technical success is defined as absence of angiographic evidence of bleeding from the target location at completion of the index embolization procedure. Assessment performed on a per-lesion basis.
Time frame: Immediately after completion of the index procedure
Clinical Success at 7 Days
Clinical success defined as absence of bleeding from the target location after embolization without need for re-embolization or other re-interventions due to persistent or recurrent hemorrhage.
Time frame: 7 ± 2 days after embolarization
Clinical Success at 3 Months (Optional Follow-up)
Clinical success as defined for the primary endpoint, assessed at optional long-term follow-up.
Time frame: 90 ± 15 days after embolization
Successful Device Delivery
Successful delivery is defined as administration of Histoacryl® with intact microcatheter retrieval at the end of the embolization procedure.
Time frame: During the index embolization procedure
Immediate Clinical Improvement
Immediate clinical improvement is achieved when at least one unstable baseline parameter (systolic blood pressure, respiratory rate, Glasgow Coma Scale, or diuresis when applicable) improves to a stable level and none deteriorates to an unstable level after the embolization procedure. Definition of Glasgow Scale (GCS): is a clinical diagnostic tool widely used since the 1970s to assess a patient's level of consciousness. Initially primarily utilized in patients with traumatic brain injuries, its utilization has extended to assess the level of consciousness. The GCS score takes into consideration three components: eye movements, verbal response (e.g., speech), and motor response (e.g. purposeful body movements).
Time frame: Immediately after completion of embolization
Freedom From Serious Adverse Events (SAEs)
Proportion of patients without serious adverse events following embolization.
Time frame: 7 days, 30 days, and optional 90 days after embolization
Major Procedure-Related Complications
Occurrence of major relevant procedure-related complications including non-target embolization, allergic reaction, and catheter breakage or entrapment.
Time frame: During the index procedure
Ischemic Complications at the Target Location
Occurrence of ischemic complications in the target location following embolization.
Time frame: Index procedure through 90 days
Device-Related Serious Adverse Events
Occurrence of serious adverse events considered related to Histoacryl®
Time frame: Index procedure through 90 days
All-Cause Mortality
Death from any cause following embolization treatment.
Time frame: Up to 90 days after embolization
Bleeding-Related Mortality
Death attributable to the target location bleeding event.
Time frame: Up to 90 days after embolization
Surgical Conversion
Need for surgical intervention because of persistent or recurrent bleeding not controlled by embolization.
Time frame: During the index hospitalization
Length of Hospital Stay
Duration of hospitalization following the embolization procedure.
Time frame: From procedure date until hospital discharge (up to 30 days)
Unplanned Rehospitalization
Occurrence of rehospitalization that was not planned at the time of discharge.
Time frame: Up to 30 days after embolization
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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