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Not yet recruiting NCT07753005

HISTOACRYL® Used for Embolization of Thoracoabdominal Artery Bleeding

— Observational Hemorrhage Gastrointestinal Hemorrhage Hemoptysis Postpartum Hemorrhage

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Embolization therapy.
Who it may be relevant to
Registry conditions: Hemorrhage, Gastrointestinal Hemorrhage, Hemoptysis, Postpartum Hemorrhage. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Japan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Observational, Prospective, Multicenter Study on HISTOACRYL® Used for Embolization of Thoracoabdominal Artery Bleeding (TAB)

Overview

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.

Detailed description

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.

Interventions

  • 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".

Primary outcome measures

  • Clinical Success at 1 Month After Histoacryl® Embolization [Time frame: 30 ± 10 days after index embolization procedure]
Secondary outcome measures (12)
  • Technical Success of Embolarization [Time frame: Immediately after completion of the index procedure]
  • Clinical Success at 7 Days [Time frame: 7 ± 2 days after embolarization]
  • Clinical Success at 3 Months (Optional Follow-up) [Time frame: 90 ± 15 days after embolization]
  • Successful Device Delivery [Time frame: During the index embolization procedure]
  • Immediate Clinical Improvement [Time frame: Immediately after completion of embolization]
  • Freedom From Serious Adverse Events (SAEs) [Time frame: 7 days, 30 days, and optional 90 days after embolization]
  • Major Procedure-Related Complications [Time frame: During the index procedure]
  • Ischemic Complications at the Target Location [Time frame: Index procedure through 90 days]
  • Device-Related Serious Adverse Events [Time frame: Index procedure through 90 days]
  • All-Cause Mortality [Time frame: Up to 90 days after embolization]
  • Bleeding-Related Mortality [Time frame: Up to 90 days after embolization]
  • Surgical Conversion [Time frame: During the index hospitalization]

Eligibility criteria

Inclusion criteria

  • Active thoracoabdominal arterial bleeding diagnosed by endoscopy, catheter angiography, or computed tomography angiography (CTA).
  • Planned embolization treatment using Histoacryl® as the sole embolic agent for the target lesion.
  • No endoleak following thoracic endovascular aortic repair (TEVAR) or endovascular abdominal aortic repair (EVAR).
  • Patients with malignant tumors must have an expected survival of at least 1 month.
  • Written informed consent obtained from the patient or a legally authorized representative.

Exclusion criteria

  • Previous embolization in the target vascular territory.
  • Known allergy or hypersensitivity to n-butyl cyanoacrylate (NBCA), Lipiodol®, or related treatment components.
  • Use of adjunctive embolic agents in the same target location.
  • Planned surgical treatment after embolization as part of a predefined two-step treatment strategy.
  • Severe septicemia.
  • Participation in another clinical trial.
  • Target vessels unsuitable for safe Histoacryl® injection.
  • Empiric embolization without identification of a target bleeding location.
  • Pregnancy, with the exception of patients treated for postpartum hemorrhage.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Japan · 11 centers
  • Aichi Cancer Center Hospital — Nagoya
  • Fujita Health University Hospital — Toyoake
  • National Cancer Center Hospital East — Kashiwa
  • Gifu University Hospital — Gifu
  • Hokkaido University Hospital — Sapporo
  • Hyogo Medical University Hospital — Nishinomiya
  • St. Marianna University Hospital — Kawasaki
  • Nara Medical University Hospital — Kashihara
  • … and 3 more centers

Identifiers

NCT: NCT07753005 · AAG-O-H-25119

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗