Seraseal for Endoscopic Hemostasis

Study Overview
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Brief Summary
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Patients with active gastrointestinal bleeding can be included. 5ml of SerasealTM/Fastact (Wortham Laboratories, Chattanooga, USA), a CE-certified medical product for in human intraoperative use as hemostatic agent, is topically applied via catheters to the bleeding site. In group A, Seraseal is applied as initial method for hemostasis. In group B, Seraseal is applied after an initial failure of the institutional standard method. Homeostatic success is determined by 5 min without bleeding at gastrointestinal site. after application of Seraseal.

Detailed Description
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Following endoscopic confirmation of a bleeding, 2,5-5ml of liquid Seraseal / Fastact, certified for intraoperative use in humans (CE No 0653), is topically applied to the bleeding site. The delivery device consisted of a 5ml syringe containing Seraseal plugged to standard delivery catheters, either ERCP catheters or dye spraying catheters (Boston Scientific, USA) that are inserted via the working channel of the endoscope. Once the bleeding is identified at endoscopy, the delivery catheter is inserted through the endoscope and positioned toward the lesion, leaving 1-2 cm between the bleeding site and the catheter tip. Seraseal is then delivered in short spray bursts or direct shots (for 1-2 seconds) until hemostasis is confirmed. A maximum of 5ml of Seraseal is administered in each patient. Homeostatic success is determined by 5 min without bleeding at gastrointestinal site. after application of Seraseal. Two groups are formed for analysis of this proof of concept study: In group A, Seraseal is applied as initial method for hemostasis. If successful, the bleeding site is then observed for 5 minutes. If bleeding remains active or recurs, the institutional standard of care for hemostasis is applied. In group B, Seraseal is applied as rescue therapy after an initial failure of the institutional standard method. If Seraseal is successful, the bleeding site is then observed for 5 minutes. If the bleeding remains active or recurs after Seraseal, alternative methods of hemostasis will be applied.

Official Title
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A Multi-centre Proof of Concept Study to Assess Efficacy and Safety of a New Liquid Endoscopic Hemostatic Agent (Seraseal / Fastact ®) in Patients With Active Gastrointestinal Bleeding

Conditions
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Gastrointestinal Hemorrhage

Intervention / Treatment
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* Device: Seraseal / Fastact Hemostatic agent (combined activated factors IIa, VIIa, IXa, Xa )


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: active gastrointestinal hemorrhage Exclusion Criteria: no sign of active bleeding at endoscopy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A first line therapy<br>In group A, Seraseal is applied as initial method for hemostasis. If successful, the bleeding site isthen observed for 5 minutes. If bleeding remains active or recurs the institutional standard of care for hemostasis is applied. | Device: Seraseal / Fastact Hemostatic agent (combined activated factors IIa, VIIa, IXa, Xa )<br>* Following endoscopic confirmation of a bleeding, 2,5-5ml of liquid Seraseal / Fastact, is topically applied to the bleeding site via catheter<br>|
| Active Comparator: Group B rescue therapy<br>In group B, Seraseal is applied as rescue therapy after an initial failure of the institutional standard method. If Seraseal was successful, the bleeding site was then observed for 5 minutes. If the bleeding remains active or recurs after Seraseal, alternative methods of hemostasis would be applied. | Device: Seraseal / Fastact Hemostatic agent (combined activated factors IIa, VIIa, IXa, Xa )<br>* Following endoscopic confirmation of a bleeding, 2,5-5ml of liquid Seraseal / Fastact, is topically applied to the bleeding site via catheter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemostasis | Success (=Hemostasis) for 5 minutes after Seraseal application | 5min | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastrointestinal hemorrhage, endoscopy, hemostasis