Seraseal for Endoscopic Hemostasis

NCT ID: NCT02349490

Last Updated: 2015-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2015-01-31

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.

Conditions

Gastrointestinal Hemorrhage

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

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

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• active gastrointestinal hemorrhage

Exclusion Criteria

• no sign of active bleeding at endoscopy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Arnulf Ferlitsch, MD

Assoc Prof. PD Dr Arnulf Ferlitsch

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arnulf Ferlitsch, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

KH der Elisabethinen Linz

Linz, Upper Austria, Austria

Division of Gastroenterology, Medical University of Vienna

Vienna, Vienna, Austria

Rudolfstiftung

Vienna, Vienna, Austria

Hannover Medical School

Hanover, , Germany

Countries

Austria; Germany

References

Ferlitsch A, Puspok A, Bota S, Wewalka F, Schoefl R, Brownstone E, Madl C, Lenzen H, Lankisch TO, Dolak W, Trauner MH, Ferlitsch M. Efficacy and safety of bovine activated factors IIa/VIIa/IXa/Xa in patients with active gastrointestinal bleeding: a proof of concept study. Endoscopy. 2016 Apr;48(4):380-4. doi: 10.1055/s-0034-1393312. Epub 2015 Nov 12.

Reference Type: DERIVED

PMID: 26561916 (View on PubMed)

Other Identifiers

Seraseal1

Identifier Type: -

Identifier Source: org_study_id