Seraseal for Endoscopic Hemostasis

NCT02349490 | Completed Phase 4

• 1 other identifier: Seraseal1
• Study Type: interventional
• Target: 37
• Locations: 2 countries
• Sites: 4

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.

Conditions

Gastrointestinal Hemorrhage

Keywords

gastrointestinal hemorrhage; endoscopy; hemostasis

Outcome Measures

Primary Outcomes (1)

• Hemostasis

  Success (=Hemostasis) for 5 minutes after Seraseal application

  5min

Study Arms (2)

Group A first line therapy

ACTIVE COMPARATOR

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 )

Group B rescue therapy

ACTIVE COMPARATOR

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 )

Interventions

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

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

Group A first line therapy; Group B rescue therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• active gastrointestinal hemorrhage

You may not qualify if:

• no sign of active bleeding at endoscopy

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (4)

KH der Elisabethinen Linz

Linz, Upper Austria, 4020, Austria

Location

Division of Gastroenterology, Medical University of Vienna

Vienna, Vienna, 1090, Austria

Location

Rudolfstiftung

Vienna, Vienna, 2030, Austria

Location

Hannover Medical School

Hanover, Germany

Location

Related Publications (1)

• 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.

  PMID: 26561916 DERIVED

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Arnulf Ferlitsch, MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof. PD Dr Arnulf Ferlitsch

Study Record Dates

• First Submitted: January 18, 2015
• First Posted: January 29, 2015
• Study Start: November 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: January 1, 2015
• Last Updated: January 29, 2015

Record last verified: 2015-01

Locations

DE (1); AU (3)