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Seraseal for Endoscopic Hemostasis

NCT02349490 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2015-01-29

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Arnulf Ferlitsch, MD · Medical University of Vienna

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2013-07-31
Completion
2015-01-31

Countries

  • Austria
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02349490 on ClinicalTrials.gov