Bleeding (Oozing) in Hepatic ResectionPhase 2NCT01244425
Fibrin Sealant VH S/D 500 S-apr in Hepatic Resection
A Phase 2 study testing Fibrin Sealant (FS) VH S/D 500 s-apr and Manual compression in people with Bleeding (Oozing) in Hepatic Resection, run by Baxter Healthcare Corporation at 7 sites in Germany.
Trial summary
The purpose of the study is to compare safety and efficacy of Fibrin Sealant (FS) Vapor Heated (VH) S/D 500 s-apr with manual compression as a supportive treatment of local bleeding (i.e. oozing) in hepatic resection surgery when standard surgical techniques are insufficient. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bleeding (Oozing) in Hepatic Resection
- What is being tested?
- Fibrin Sealant (FS) VH S/D 500 s-apr and Manual compression
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 7 sitesGermany
- Study dates
- Nov 2010to Jul 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Pre-Operative Inclusion Criteria:
- Signed informed consent obtained from the subject before any study-related activities
- Subject's age is 18 years or above
- Subject will undergo planned, elective resection of at least 1 anatomical segment of the liver for any reason by laparotomy
- Subject is willing and able to comply with the requirements of the protocol
- Female subjects of childbearing potential must present with a negative serum or urine pregnancy test within 72 hours before the elective liver resection
- Female subjects of childbearing potential must agree to employ adequate birth control measures for the time of their participation in the study
Intra-Operative Inclusion Criteria (before randomization):
- Resection of at least 1 anatomical segment of the liver has been performed
- Oozing from the cut surface of the liver persists after conventional resection procedure and primary control of arterial and venous bleeding by sutures, ligations, clips, vascular stapler, point electrocautery or focal radiofrequency ablation
- Need for additional supportive hemostatic treatment to stop bleeding (i.e. diffuse oozing) of the liver resection area
Pre-Operative Exclusion Criteria:
- Subject needs emergency liver surgery
- Subject will undergo liver resection via laparoscopic procedure
- Subject has known congenital coagulation disorder (e.g. hemophilia)
- Subject has known hypersensitivity to any ingredient of the investigational medicinal product
- Suspected inability or unwillingness of the subject to comply with trial procedures
- If female, subject is pregnant or lactating at the time of study enrollment
- Subject has already participated in this study (each subject can only be enrolled once)
- Subject has participated in another clinical study involving an investigational product or investigational device within 30 days prior to study enrollment or is scheduled to participate in another clinical study involving an investigational product or investigational device during the course of this study
Intra-operative Exclusion Criteria (before randomization):
- Occurrence of any severe surgical complication that require resuscitation or deviation from the planned surgical procedure
- Disseminated intravascular coagulopathy (DIC)
- Application of any topical hemostatic material on the resection surface of the liver prior to application of the study treatment
- Radiofrequency precoagulation of the liver resection surface, except focal use of radiofrequency as primary hemostatic treatment
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Germany7 sites
Study site
Berlin
Study site
Essen
Study site
Hanover
Study site
Heidelberg
Study site
Jena
Study site
Leipzig
Study site
Tübingen
About this study
Official title: A Randomized, Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Fibrin Sealant VH S/D 500 S-apr (Tisseel) for Hemostasis in Subjects Undergoing Hepatic Resection
The purpose of the study is to compare safety and efficacy of Fibrin Sealant (FS) Vapor Heated (VH) S/D 500 s-apr with manual compression as a supportive treatment of local bleeding (i.e. oozing) in hepatic resection surgery when standard surgical techniques are insufficient.
- Conditions
- Bleeding (Oozing) in Hepatic Resection
- Being tested
- Fibrin Sealant (FS) VH S/D 500 s-apr, Manual compression
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibrin Sealant (FS) VH S/D 500 s-aprDrug
Also called Tisseel
Dosage form: spray application; dosage frequency: single application
Manual compressionOther
Dosage form: surgical gauze swab; dosage frequency: single application
| Study group | Role | What they receive |
|---|---|---|
| FS VH S/D 500 s-apr | Experimental | Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant. Hemostasis will be assessed at 4, 6, 8 and 10 minutes after application of the study treatment. Receives: Drug: Fibrin Sealant (FS) VH S/D 500 s-apr |
| Manual compression - Control | Active comparator | A dry surgical gauze swab will be used to apply by hand an even light pressure onto the oozing resection surface of the liver. Hemostasis will be assessed at 4, 6, 8 and 10 minutes after application of the study treatment. Receives: Other: Manual compression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Intraoperative Hemostasis at 4 Minutes After Treatment Application
Hemostasis defined as no visible bleeding on the liver resection surface (liver surgical site) after treatment application. Hemostasis had to be maintained until surgical closure. Time recording started with treatment application, ie, with the start of spraying Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) or with the application of manual compression.
The following were regarded as treatment failures:
- No hemostasis achieved at 4 minutes post treatment application (for the FS VH S/D 500 s-apr arm, the "time to hemostasis" was used; a time window of +5 seconds was acceptable for showing a success)
- Additional hemostatic treatment (ie, hemostatics in addition to the randomized treatment) was required
- Reapplication of FS VH S/D 500 s-apr after 4 minutes
- Intraoperative rebleeding after the first 4 minutes of the observation period
Measured: 4 minutes post start of treatment application
Secondary outcomes (7)
Percentage of Participants With Intraoperative Hemostasis at 6 Minutes After Application of the Randomized Treatment
Hemostasis defined as no visible bleeding on the liver resection surface (liver surgical site) after treatment application. Hemostasis had to be maintained until surgical closure. Time recording started with treatment application, ie, with the start of spraying Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) or with the application of manual compression.
Measured: 6 minutes after start of treatment application
Percentage of Participants With Intraoperative Hemostasis at 8 Minutes After Application of the Randomized Treatment
Hemostasis defined as no visible bleeding on the liver resection surface (liver surgical site) after treatment application. Hemostasis had to be maintained until surgical closure. Time recording started with treatment application, ie, with the start of spraying Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) or with the application of manual compression.
Measured: 8 minutes after start of treatment application
Percentage of Participants With Intraoperative Hemostasis at 10 Minutes After Application of the Randomized Treatment
Hemostasis defined as no visible bleeding on the liver resection surface (liver surgical site) after treatment application. Hemostasis had to be maintained until surgical closure. Time recording started with treatment application, ie, with the start of spraying Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) or with the application of manual compression.
Measured: 10 minutes after start of treatment application
Percentage of Participants With Intraoperative Rebleeding After Occurrence of Hemostasis
Intraoperative rebleeding from the treated liver resection surface after occurrence of hemostasis.
Measured: Intraoperative day 0
Percentage of Participants With Postoperative Rebleeding
Rebleeding until discharged from the surgical ward, defined as any rebleeding from the treated liver resection surface requiring surgical reexploration
Measured: Postoperative until discharged from surgical ward
Percentage of Participants With Transfusion Requirements Until Discharged From Surgical Ward
Transfusions administered included whole blood, packed red blood cells, fresh frozen plasma, and thrombocyte concentrate.
Measured: Intra- and postoperative until discharged from surgical ward
Median Total Volume of Postoperative Drainage Fluid Within 48 Hours After Surgery
Measured: Within 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bleeding (Oozing) in Hepatic ResectionStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxter Healthcare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Baxter Innovations GmbH
- Responsible party
- Sponsor
- Investigators
- Baxter BioScience Medical Director, MD, Study director, Baxter Healthcare Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01244425
- Sponsor's protocol ID
- 550904
- Other IDs
- 2010-018480-42
- Status last verified
- Feb 2013
- First submitted
- 18 Nov 2010
- Last updated
- 20 Feb 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Fibrin Sealant VH S/D 500 S-apr (Tisseel) for Hemostasis in Subjects Undergoing Hepatic Resection
- ClinicalTrials.gov ID
- NCT01244425
- Acronym / sponsor ID
- 550904
- Conditions
- Bleeding (Oozing) in Hepatic Resection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Baxter Innovations GmbH
- Study start
- Nov 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 19 Nov 2010 (estimated)
- Results
- Posted 12 Feb 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to compare safety and efficacy of Fibrin Sealant (FS) Vapor Heated (VH) S/D 500 s-apr with manual compression as a supportive treatment of local bleeding (i.e. oozing) in hepatic resection surgery when standard surgical techniques are insufficient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FS VH S/D 500 s-apr | Experimental | Drug: Fibrin Sealant (FS) VH S/D 500 s-aprFibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant. Hemostasis will be assessed at 4, 6, 8 and 10 minutes after application of the study treatment. |
| Manual compression - Control | Active comparator | Other: Manual compressionA dry surgical gauze swab will be used to apply by hand an even light pressure onto the oozing resection surface of the liver. Hemostasis will be assessed at 4, 6, 8 and 10 minutes after application of the study treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Fibrin Sealant (FS) VH S/D 500 s-aprAlso: TisseelDosage form: spray application; dosage frequency: single application | Drug | FS VH S/D 500 s-apr |
| Manual compressionDosage form: surgical gauze swab; dosage frequency: single application | Other | Manual compression - Control |
Primary outcome
Percentage of Participants With Intraoperative Hemostasis at 4 Minutes After Treatment Application
Time frame: 4 minutes post start of treatment application
Hemostasis defined as no visible bleeding on the liver resection surface (liver surgical site) after treatment application. Hemostasis had to be maintained until surgical closure. Time recording started with treatment application, ie, with the start of spraying Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) or with the application of manual compression. The following were regarded as treatment failures: * No hemostasis achieved at 4 minutes post treatment application (for the FS VH S/D 500 s-apr arm, the "time to hemostasis" was used; a time window of +5 seconds was acceptable for showing a success) * Additional hemostatic treatment (ie, hemostatics in addition to the randomized treatment) was required * Reapplication of FS VH S/D 500 s-apr after 4 minutes * Intraoperative rebleeding after the first 4 minutes of the observation period
7 secondary outcomes
Percentage of Participants With Intraoperative Hemostasis at 6 Minutes After Application of the Randomized Treatment
Time frame: 6 minutes after start of treatment application
Percentage of Participants With Intraoperative Hemostasis at 8 Minutes After Application of the Randomized Treatment
Time frame: 8 minutes after start of treatment application
Percentage of Participants With Intraoperative Hemostasis at 10 Minutes After Application of the Randomized Treatment
Time frame: 10 minutes after start of treatment application
Percentage of Participants With Intraoperative Rebleeding After Occurrence of Hemostasis
Time frame: Intraoperative day 0
Percentage of Participants With Postoperative Rebleeding
Time frame: Postoperative until discharged from surgical ward
Percentage of Participants With Transfusion Requirements Until Discharged From Surgical Ward
Time frame: Intra- and postoperative until discharged from surgical ward
Median Total Volume of Postoperative Drainage Fluid Within 48 Hours After Surgery
Time frame: Within 48 hours after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Baxter BioScience Medical Director, MD study director
Baxter Healthcare Corporation
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fibrin Sealant (FS) VH S/D 500 s-apr and Manual compression in people with Bleeding (Oozing) in Hepatic Resection, run by Baxter Healthcare Corporation at 7 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 20 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With Intraoperative Hemostasis at 4 Minutes After Treatment Application (time frame: 4 minutes post start of treatment application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Feb 2013.