Seraseal for Endoscopic Hemostasis

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

Sponsors

Lead Sponsor: Medical University of Vienna

Source Medical University of Vienna
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.

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.

Overall Status Completed
Start Date 2011-11-01
Completion Date 2015-01-01
Primary Completion Date 2013-07-01
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Hemostasis 5min
Enrollment 37
Condition
Intervention

Intervention Type: Device

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

Description: Following endoscopic confirmation of a bleeding, 2,5-5ml of liquid Seraseal / Fastact, is topically applied to the bleeding site via catheter

Eligibility

Criteria:

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Arnulf Ferlitsch, MD Principal Investigator Medical University of Vienna
Overall Contact Contact information is only displayed when the study is recruiting subjects.
Location
Facility:
KH der Elisabethinen Linz | Linz, Oberoesterreich, 4020, Austria
Division of Gastroenterology, Medical University of Vienna | Vienna, 1090, Austria
Rudolfstiftung | Vienna, 2030, Austria
Hannover Medical School | Hannover, Germany
Location Countries

Austria

Germany

Verification Date

2015-01-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Medical University of Vienna

Investigator Full Name: Arnulf Ferlitsch, MD

Investigator Title: Assoc Prof. PD Dr Arnulf Ferlitsch

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Group A first line therapy

Type: Active Comparator

Description: 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.

Label: Group B rescue therapy

Type: Active Comparator

Description: 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.

Study Design Info

Allocation: Non-Randomized

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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Clinical Trials on Gastrointestinal Hemorrhage

Clinical Trials on Seraseal / Fastact Hemostatic agent (combined activated factors IIa, VIIa, IXa, Xa )