HemostasisPhase 4ESSCALIVERNCT00918619
Efficacy and Safety of Sangustop® as Haemostatic Agent Versus a Carrier-Bound Fibrin Sealant During Liver Resection
A Phase 4 study testing Sangustop and Tachosil in people with Hemostasis and Liver Surgery, run by Aesculap AG at 8 sites in 2 countries.
Trial summary
This is a multi-centre, patient-blinded, intra-operatively randomised controlled trial. A total of 126 patients planned for an elective liver resection will be enrolled in 9 surgical centres. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemostasis, Liver Surgery
- What is being tested?
- Sangustop and Tachosil
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Jan 2010to Jan 2011
- 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
- Age: > 18 years
- Gender: male / female
- Patients with an indication for liver resection (segmental or non-segmental)
- Willing and able to complete the clinical trial procedures, as described in the protocol
- Signed written informed consent to participate in this clinical trial
Who cannot join
- Presence or sequelae of coagulation disorder, liver cirrhosis, Klatskin tumor
- Concurrent participation in another clinical trial with a medical device or medicinal product or with interfering endpoints
- Concurrent or previous therapy with systemic pharmacologic agents promoting blood clotting including but not limited to tranexamix acid, activated factor VII, and aprotinine
- Known allergy or hypersensitivity to a component of the investigational treatments Sangustop® or TachoSil®, to riboflavin or to proteins of bovine origin
- Pregnancy or breast feeding
- Inability to understand the nature and the extent of the trial and the procedures required
Show all 12Show fewer
- Missing signed written informed consent to participate in the study
- Exclusion criteria to be checked during surgery (liver resection):
- Resection area estimated by operating surgeon < 16cm2
- Infected wound area
- Persistant major bleeding after primary haemostasis
- No bleeding after resection
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Germany7 sites
Charité Campus Virchow, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
Berlin, 13353
Krankenhaus Nordwest, Klinik für Allgemein-, Viszeral- und Minimal Invasive Chirurgie
Frankfurt, 60488
Klinikum der J. W. Goethe-Universität, Klinik für Allgemein- und Visceralchirurgie
Frankfurt am Main, 60590
Universitätsklinikum Heidelberg
Heidelberg, 69120
Universitätsklinikum Mainz, Klinik für Allgemein- und Abdominalchirurgie
Mainz, 55131
Klinikum Großhadern, Ludwig-Maximilians-Universität
München, 81377
Technische Universität München, Chirurgische Klinik und Poliklinik
München, 81675
Austria1 site
Universitätsklinik für Chirurgie, Medizinische Universität Graz
Graz, 8036
About this study
Official title: Efficacy and Safety of Sangustop® as Haemostatic Agent Versus a Carrier-bound Fibrin Sealant During Liver Resection (ESSCALIVER)
This is a multi-centre, patient-blinded, intra-operatively randomised controlled trial. A total of 126 patients planned for an elective liver resection will be enrolled in 9 surgical centres. The primary objective of this study is to show that the collagen based haemostatic device Sangustop® is not inferior to a carrier-bound fibrin sealant (Tachosil®) in achieving haemostasis after hepatic resection.
Read the detailed description
During liver resection the control of bleeding is a major concern. The liver is predisposed to diffuse bleeding because of its extreme vascularity. Locally applicable agents (haemostats) are in use in order to achieve control over parenchymatic diffuse bleeding from the resection surface and to prevent intraperitoneal complications attributed to bleeding. These haemostats include bone wax, gelatine, collagen, oxidized regenerated cellulose, fibrin sealant glues, and synthetic glues. A composite product with well documented efficacy is Tachosil®. It consists of a collagen fleece carrying the fibrin glue components human fibrinogen and human thrombin. It was shown in a RCT to be superior in obtaining intraoperative haemostasis over argon beamer in liver resection. A new haemostat product is Sangustop®. It is indicated for local haemostasis of capillary bleeding and bleeding of parenchymal organs. Sangustop® is composed of native absorbable collagen fibrils without any blood serum products or any pharmaceutical activity. The felt structure being rich in surface gives a framework for the adhesion of blood platelets, thus provides an additional impetus to clotting. The aim of this study is to show that the new microfibrillar collagen hemostat Sangustop® is not inferior to the carrier-bound fibrin sealant Tachosil® with regards to haemostatic efficacy.
- Conditions
- Hemostasis, Liver Surgery
- Being tested
- Sangustop, Tachosil
- Keywords
- randomized,, controlled,, haemostatic agents,, Sangustop,, Tachosil,, liver resection,, haemostasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SangustopDevice
Also called Sangustop®
Application of Sangustop haemostatic agent on resection area
TachosilDrug
Also called Tachosil®
Application of Tachosil fibrin sealant on resection area
| Study group | Role | What they receive |
|---|---|---|
| Sangustop | Experimental | Not described Receives: Device: Sangustop |
| Tachosil | Active comparator | Not described Receives: Drug: Tachosil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with hemostasis 3 minutes after application of the haemostat product
Measured: 3 minutes
Secondary outcomes (1)
Time to hemostasis
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2009 (estimated)
- Study startJan 2010
- Primary completionOct 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HemostasisStudies of the same condition, open and under way.
- More trials run by Aesculap AGThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wolf O. Bechstein, Prof. Dr., Principal investigator, University Hospital, Frankfurt am Main, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00918619
- Sponsor's protocol ID
- AAG-G-H-0804
- Acronym
- ESSCALIVER
- Status last verified
- May 2015
- First submitted
- 9 Jun 2009
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Moench C, Bechstein WO, Hermanutz V, Hoexter G, Knaebel HP. Comparison of the collagen haemostat Sangustop(R) versus a carrier-bound fibrin sealant during liver resection; ESSCALIVER-Study. Trials. 2010 Nov 19;11:109. doi: 10.1186/1745-6215-11-109.
PubMed 21087530Moench C, Mihaljevic AL, Hermanutz V, Thasler WE, Suna K, Diener MK, Seehofer D, Mischinger HJ, Jansen-Winkeln B, Knaebel HP, Bechstein WO. Randomized controlled multicenter trial on the effectiveness of the collagen hemostat Sangustop(R) compared with a carrier-bound fibrin sealant during liver resection (ESSCALIVER study, NCT00918619). Langenbecks Arch Surg. 2014 Aug;399(6):725-33. doi: 10.1007/s00423-014-1203-9. Epub 2014 Jun 1.
PubMed 24880345Malik AK, Amer AO, Tingle SJ, Thompson ER, White SA, Manas DM, Wilson C. Fibrin-based haemostatic agents for reducing blood loss in adult liver resection. Cochrane Database Syst Rev. 2023 Aug 8;8(8):CD010872. doi: 10.1002/14651858.CD010872.pub2.
PubMed 37551841
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Sangustop® as Haemostatic Agent Versus a Carrier-bound Fibrin Sealant During Liver Resection (ESSCALIVER)
- ClinicalTrials.gov ID
- NCT00918619
- Acronym / sponsor ID
- ESSCALIVER / AAG-G-H-0804
- Conditions
- Hemostasis, Liver Surgery
- Keywords
- randomized,, controlled,, haemostatic agents,, Sangustop,, Tachosil,, liver resection,, haemostasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 11 Jun 2009 (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.
This is a multi-centre, patient-blinded, intra-operatively randomised controlled trial. A total of 126 patients planned for an elective liver resection will be enrolled in 9 surgical centres. The primary objective of this study is to show that the collagen based haemostatic device Sangustop® is not inferior to a carrier-bound fibrin sealant (Tachosil®) in achieving haemostasis after hepatic resection.
Detailed description
During liver resection the control of bleeding is a major concern. The liver is predisposed to diffuse bleeding because of its extreme vascularity. Locally applicable agents (haemostats) are in use in order to achieve control over parenchymatic diffuse bleeding from the resection surface and to prevent intraperitoneal complications attributed to bleeding. These haemostats include bone wax, gelatine, collagen, oxidized regenerated cellulose, fibrin sealant glues, and synthetic glues. A composite product with well documented efficacy is Tachosil®. It consists of a collagen fleece carrying the fibrin glue components human fibrinogen and human thrombin. It was shown in a RCT to be superior in obtaining intraoperative haemostasis over argon beamer in liver resection. A new haemostat product is Sangustop®. It is indicated for local haemostasis of capillary bleeding and bleeding of parenchymal organs. Sangustop® is composed of native absorbable collagen fibrils without any blood serum products or any pharmaceutical activity. The felt structure being rich in surface gives a framework for the adhesion of blood platelets, thus provides an additional impetus to clotting. The aim of this study is to show that the new microfibrillar collagen hemostat Sangustop® is not inferior to the carrier-bound fibrin sealant Tachosil® with regards to haemostatic efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sangustop | Experimental | Device: Sangustop |
| Tachosil | Active comparator | Drug: Tachosil |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: > 18 years
- Gender: male / female
- Patients with an indication for liver resection (segmental or non-segmental)
- Willing and able to complete the clinical trial procedures, as described in the protocol
- Signed written informed consent to participate in this clinical trial
Key exclusion criteria (12 listed)
- Presence or sequelae of coagulation disorder, liver cirrhosis, Klatskin tumor
- Concurrent participation in another clinical trial with a medical device or medicinal product or with interfering endpoints
- Concurrent or previous therapy with systemic pharmacologic agents promoting blood clotting including but not limited to tranexamix acid, activated factor VII, and aprotinine
- Known allergy or hypersensitivity to a component of the investigational treatments Sangustop® or TachoSil®, to riboflavin or to proteins of bovine origin
- Pregnancy or breast feeding
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 |
|---|---|---|
| SangustopAlso: Sangustop®Application of Sangustop haemostatic agent on resection area | Device | Sangustop |
| TachosilAlso: Tachosil®Application of Tachosil fibrin sealant on resection area | Drug | Tachosil |
Primary outcome
Proportion of patients with hemostasis 3 minutes after application of the haemostat product
Time frame: 3 minutes
1 secondary outcome
Time to hemostasis
Time frame: 10 minutes
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 28 May 2015.
- Background: PubMed 21087530Moench C, Bechstein WO, Hermanutz V, Hoexter G, Knaebel HP. Comparison of the collagen haemostat Sangustop(R) versus a carrier-bound fibrin sealant during liver resection; ESSCALIVER-Study. Trials. 2010 Nov 19;11:109. doi: 10.1186/1745-6215-11-109.
- Results publication: PubMed 24880345Moench C, Mihaljevic AL, Hermanutz V, Thasler WE, Suna K, Diener MK, Seehofer D, Mischinger HJ, Jansen-Winkeln B, Knaebel HP, Bechstein WO. Randomized controlled multicenter trial on the effectiveness of the collagen hemostat Sangustop(R) compared with a carrier-bound fibrin sealant during liver resection (ESSCALIVER study, NCT00918619). Langenbecks Arch Surg. 2014 Aug;399(6):725-33. doi: 10.1007/s00423-014-1203-9. Epub 2014 Jun 1.
- Derived from this study: PubMed 37551841Malik AK, Amer AO, Tingle SJ, Thompson ER, White SA, Manas DM, Wilson C. Fibrin-based haemostatic agents for reducing blood loss in adult liver resection. Cochrane Database Syst Rev. 2023 Aug 8;8(8):CD010872. doi: 10.1002/14651858.CD010872.pub2.
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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.
Wolf O. Bechstein, Prof. Dr. principal investigator
University Hospital, Frankfurt am Main, Germany
8 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 Sangustop and Tachosil in people with Hemostasis and Liver Surgery, run by Aesculap AG at 8 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 5 inclusion and 12 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 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany, Austria. 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?
Proportion of patients with hemostasis 3 minutes after application of the haemostat product (time frame: 3 minutes). 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 NCT00918619, which also lists 3 linked publications.
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 28 May 2015.