Early Selective TAE to Severely Bleeding Peptic Ulcers After Their Initial Endoscopic Hemostasis
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|ClinicalTrials.gov Identifier: NCT01142180|
Recruitment Status : Completed
First Posted : June 11, 2010
Last Update Posted : July 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Bleeding Peptic Ulcer Arterial Embolization||Procedure: TAE Procedure: No TAE||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||258 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Early Selective Angiographic Embolization to Severely Bleeding Peptic Ulcers After Their Initial Endoscopic Hemostasis - a Randomized Controlled Trial|
|Actual Study Start Date :||January 2010|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2014|
Active Comparator: TAE group
Patients will be undergone TAE after endoscopic hemostasis.
The procedure will be performed within 12 hours of endoscopic therapy. This is usually performed under conscious sedation
Other Name: Transarterial embolization
Active Comparator: No TAE group
No TAE procedure will be performed after endoscopic treatment.
Procedure: No TAE
No TAE procedure will be performed after endoscopic treatment
- clinical re-bleeding [ Time Frame: within 30 days of therapy ]
Clinical rebleeding is defined by fresh hematemesis, fresh melena or hematochezia and signs of hypovolemic shock (systolic blood pressure of <90mmHg and pulse rate >110 per minute) and a drop in hemoglobin of > 2 g/dl per 24 hours despite adequate transfusion.
Rebleeding will be confirmed by an immediate endoscopy showing fresh blood in stomach or active bleeding from a previously seen ulcer. A clinical rebleeding will be independently reviewed by an adjudication panel.
- death from all causes [ Time Frame: within 30 days of therapy ]death from all causes
- transfusion requirement [ Time Frame: within 30 days of therapy ]transfusion requirement
- hospital stay including Intensive Care Unit stay [ Time Frame: within 30 days of therapy ]hospital stay including Intensive Care Unit stay
- further interventions either further TAE or surgery [ Time Frame: within 30 days of therapy ]further interventions either further TAE or surgery
- hospital costs [ Time Frame: within 30 days of therapy ]hospital costs
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01142180
|Endoscopy Centre, Prince of Wales Hospital|
|Hong Kong, China|
|Principal Investigator:||James Y LAU, MD||Chinese University of Hong Kong|