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Seraseal for Endoscopic Hemostasis

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ClinicalTrials.gov Identifier: NCT02349490
Recruitment Status : Completed
First Posted : January 29, 2015
Last Update Posted : January 29, 2015
Sponsor:
Information provided by (Responsible Party):
Arnulf Ferlitsch, MD, Medical University of Vienna

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Hemorrhage Device: Seraseal / Fastact Hemostatic agent (combined activated factors IIa, VIIa, IXa, Xa ) Phase 4

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2011
Actual Primary Completion Date : July 2013
Actual Study Completion Date : January 2015

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Group A first line therapy
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 )
Following endoscopic confirmation of a bleeding, 2,5-5ml of liquid Seraseal / Fastact, is topically applied to the bleeding site via catheter
Active Comparator: Group B rescue therapy
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 )
Following endoscopic confirmation of a bleeding, 2,5-5ml of liquid Seraseal / Fastact, is topically applied to the bleeding site via catheter


Outcome Measures
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Primary Outcome Measures :
  1. Hemostasis [ Time Frame: 5min ]
    Success (=Hemostasis) for 5 minutes after Seraseal application


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • active gastrointestinal hemorrhage

Exclusion Criteria:

  • no sign of active bleeding at endoscopy
Contacts and Locations
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Information from the National Library of Medicine

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): NCT02349490


Locations
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Austria
KH der Elisabethinen Linz
Linz, Oberoesterreich, Austria, 4020
Division of Gastroenterology, Medical University of Vienna
Vienna, Austria, 1090
Rudolfstiftung
Vienna, Austria, 2030
Germany
Hannover Medical School
Hannover, Germany
Sponsors and Collaborators
Medical University of Vienna
Investigators
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Principal Investigator: Arnulf Ferlitsch, MD Medical University of Vienna
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Arnulf Ferlitsch, MD, Assoc Prof. PD Dr Arnulf Ferlitsch, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02349490    
Other Study ID Numbers: Seraseal1
First Posted: January 29, 2015    Key Record Dates
Last Update Posted: January 29, 2015
Last Verified: January 2015
Keywords provided by Arnulf Ferlitsch, MD, Medical University of Vienna:
gastrointestinal hemorrhage
endoscopy
hemostasis
Additional relevant MeSH terms:
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Gastrointestinal Hemorrhage
Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
 Digestive System Diseases
Hemostatics
Coagulants