Gastrointestinal Hemorrhage, Hemoptysis, Hemorrhage, Postpartum Hemorrhage
Conditions
Keywords
Embolization, Endovascular embolization, Histoacryl, N-butyl cyanoacrylate, NBCA, Hemostasis, Interventional radiology, Thoracoabdominal artery bleeding, Transcatheter arterial embolization, Arterial embolization, Acute arterial hemorrhage, Visceral Aneurysm
Brief summary
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
DEVICEEmbolization therapy
Embolization of Thoracoabdominal Artery Bleeding (TAB), excluding "Cardiac blood vessels other than Pulmonary artery", "Endoscopic esophageal varices embolization operations", and "Pulmonary artery malformation".
Sponsors
Aesculap AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Success at 1 Month After Histoacryl® Embolization | 30 ± 10 days after index embolization procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical Success of Embolarization | Immediately after completion of the index procedure | 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. |
| Clinical Success at 7 Days | 7 ± 2 days after embolarization | 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. |
| Clinical Success at 3 Months (Optional Follow-up) | 90 ± 15 days after embolization | Clinical success as defined for the primary endpoint, assessed at optional long-term follow-up. |
| Successful Device Delivery | During the index embolization procedure | Successful delivery is defined as administration of Histoacryl® with intact microcatheter retrieval at the end of the embolization procedure. |
| Immediate Clinical Improvement | Immediately after completion of embolization | 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). |
| Freedom From Serious Adverse Events (SAEs) | 7 days, 30 days, and optional 90 days after embolization | Proportion of patients without serious adverse events following embolization. |
| Major Procedure-Related Complications | During the index procedure | Occurrence of major relevant procedure-related complications including non-target embolization, allergic reaction, and catheter breakage or entrapment. |
| Ischemic Complications at the Target Location | Index procedure through 90 days | Occurrence of ischemic complications in the target location following embolization. |
| Device-Related Serious Adverse Events | Index procedure through 90 days | Occurrence of serious adverse events considered related to Histoacryl® |
| All-Cause Mortality | Up to 90 days after embolization | Death from any cause following embolization treatment. |
| Bleeding-Related Mortality | Up to 90 days after embolization | Death attributable to the target location bleeding event. |
| Surgical Conversion | During the index hospitalization | Need for surgical intervention because of persistent or recurrent bleeding not controlled by embolization. |
| Length of Hospital Stay | From procedure date until hospital discharge (up to 30 days) | Duration of hospitalization following the embolization procedure. |
| Unplanned Rehospitalization | Up to 30 days after embolization | Occurrence of rehospitalization that was not planned at the time of discharge. |
Countries
Japan
Contacts
CONTACTMarta Soteras, Dr.
CONTACTYumiko Okaniva, Dr.
PRINCIPAL_INVESTIGATORMiyuki Sone, Dr.
National Cancer Center Hospital
Outcome results
None listed