Gastrointestinal HemorrhagePhase 4NCT02349490
Seraseal for Endoscopic Hemostasis
A Phase 4 study testing Seraseal / Fastact Hemostatic agent (combined activated factors IIa, VIIa, IXa, Xa ) in people with Gastrointestinal Hemorrhage, run by Medical University of Vienna at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Hemorrhage
- What is being tested?
- Seraseal / Fastact Hemostatic agent (combined activated factors IIa, VIIa, IXa, Xa )
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Nov 2011to Jan 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- active gastrointestinal hemorrhage
Who cannot join
- no sign of active bleeding at endoscopy
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Austria3 sites
KH der Elisabethinen Linz
Linz, Upper Austria, 4020
Division of Gastroenterology, Medical University of Vienna
Vienna, State of Vienna, 1090
Rudolfstiftung
Vienna, State of Vienna, 2030
About this study
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
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.
Read the 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
- Being tested
- Seraseal / Fastact Hemostatic agent (combined activated factors IIa, VIIa, IXa, Xa )
- Keywords
- gastrointestinal hemorrhage, endoscopy, hemostasis
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Seraseal / Fastact Hemostatic agent (combined activated factors IIa, VIIa, IXa, Xa ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemostasis
Success (=Hemostasis) for 5 minutes after Seraseal application
Measured: 5min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2015 (estimated)
- Study startNov 2011
- Primary completionJul 2013
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal HemorrhageStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arnulf Ferlitsch, MD, Medical University of Vienna
- Investigators
- Arnulf Ferlitsch, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02349490
- Sponsor's protocol ID
- Seraseal1
- Status last verified
- Jan 2015
- First submitted
- 18 Jan 2015
- Last updated
- 29 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26561916
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02349490
- Acronym / sponsor ID
- Seraseal1
- Conditions
- Gastrointestinal Hemorrhage
- Keywords
- gastrointestinal hemorrhage, endoscopy, hemostasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 29 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A first line therapy | Active comparator | Device: Seraseal / Fastact Hemostatic agent (combined activated factors IIa, VIIa, IXa, Xa )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 B rescue therapy | Active comparator | Device: Seraseal / Fastact Hemostatic agent (combined activated factors IIa, VIIa, IXa, Xa )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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- active gastrointestinal hemorrhage
Key exclusion criteria (1 listed)
- no sign of active bleeding at endoscopy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | Group A first line therapy, Group B rescue therapy |
Primary outcome
Hemostasis
Time frame: 5min
Success (=Hemostasis) for 5 minutes after Seraseal application
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2015.
- Derived from this study: PubMed 26561916Ferlitsch 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arnulf Ferlitsch, MD principal investigator
Medical University of Vienna
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Seraseal / Fastact Hemostatic agent (combined activated factors IIa, VIIa, IXa, Xa ) in people with Gastrointestinal Hemorrhage, run by Medical University of Vienna at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Austria, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemostasis (time frame: 5min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02349490, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2015; AzTrials last refreshed its copy on 31 Oct 2026.