Postoperative HemorrhagePhase 2NCT01256190
A Study of Fibrocaps in Liver Surgery in the Netherlands
A Phase 2 study testing Fibrocaps (fibrin sealant) and Gelatin sponge in people with Postoperative Hemorrhage, run by Mallinckrodt at 1 site in Netherlands.
Trial summary
A multi-center, prospective, randomized, single-blind, controlled, comparative efficacy and safety trial in subjects undergoing open liver resection surgery. The study will enroll 42 eligible subjects and be conducted at 4 sites in the Netherlands. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Hemorrhage
- What is being tested?
- Fibrocaps (fibrin sealant) and Gelatin sponge
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2010to Oct 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
Who may be able to join
- Male or female ≥ 18 years of age
- Subjects who are able and willing to provide written and signed informed consent
- Willing to use a medically accepted form of contraception from the time of consent to completion of all follow-up study visits
- Has a life expectancy of at least one year
- Presence of mild or moderate bleeding/oozing and control by conventional surgical techniques including but not limited to suture, ligature, and cautery is ineffective or impractical
Who cannot join
- Pregnant or lactating women
- Has a known intolerance to blood products or to Fibrocaps components
- Unwilling to receive human blood products
- Subject has a known allergy to porcine gelatin
- Has a mental or physical condition that would, in the opinion of the Investigator, place the subject at an unacceptable risk or render the subject unable to meet the requirements of the protocol
- Currently participating or has participated in another clinical study involving another investigational agent within 4 weeks of the planned date of surgery, or is planning participation in another clinical trial during the 4 weeks after surgery
Show all 10Show fewer
- Has any clinically-significant coagulation disorder that may interfere with the assessment of efficacy or pose a safety risk to the subject according to the Investigator
- Platelets(PLT) < 100 x109 PLT/L during screening
- Activated Partial Thromboplastin Time (aPTT) > 100 seconds during screening
- International Normalized Ratio (INR) > 2.5 during screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2, Randomized, Single-Blind, Controlled, Comparative Efficacy and Safety and Study of Topical Fibrocaps™ and Gelatin Sponge in Surgical Hemostasis in the Netherlands
A multi-center, prospective, randomized, single-blind, controlled, comparative efficacy and safety trial in subjects undergoing open liver resection surgery. The study will enroll 42 eligible subjects and be conducted at 4 sites in the Netherlands.
Read the detailed description
This will be a multi-center, prospective, randomized, single-blind, controlled, comparative efficacy and safety trial in 60 subjects undergoing hepatic resection. Subjects will be randomized in a 2:1 ratio to Fibrocaps + Gelfoam or Gelfoam on the day of surgery.
The Fibrospray device will be used to apply Fibrocaps to the Target Bleeding Site. All investigators using the Fibrospray device will be trained on the correct and safe set-up and use of Fibrocaps and the Fibrospray device prior to participating in this clinical trial.
- Conditions
- Postoperative Hemorrhage
- Being tested
- Fibrocaps (fibrin sealant), Gelatin sponge
- Medical subject headings
- Postoperative Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibrocaps (fibrin sealant)Biological
Also called PRO-0601, Fibrin Sealant
human thrombin and fibrinogen topical powder
Gelatin spongeDevice
Also called Spongostan
absorbable gelatin sponge for topical use
| Study group | Role | What they receive |
|---|---|---|
| Fibrocaps + Gelatin sponge | Experimental | Topical Fibrocaps powder followed by application of gelatin sponge Receives: Biological: Fibrocaps (fibrin sealant); Device: Gelatin sponge |
| Gelatin Sponge | Active comparator | approved device for surgical bleeding Receives: Device: Gelatin sponge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Hemostasis
Time from application of treatment to cessation of bleeding
Measured: 0-10 minutes
Secondary outcomes (4)
Safety
Number of participants with Adverse events and clinically significant changes/findings on labs and physical examination as well as incidence of re-operation for bleeding at the target bleeding site (TBS)
Measured: 28 days
Incidence of Hemostasis at 5 Minutes
Number of subjects in each group that achieved hemostasis at pre-specified times after treatment
Measured: 5 minutes
Number of Subjects Achieving Hemostasis at 3 Minutes
Measured: 3 minutes
Number of Patients Achieving Hemostasis at 10 Minutes
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 posted8 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionSep 2011
- Study completionOct 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative HemorrhageStudies 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
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mallinckrodt
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Frohna, MD, PhD, Study director, Mallinckrodt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01256190
- Sponsor's protocol ID
- FC-002 NL
- Status last verified
- Jul 2016
- First submitted
- 6 Dec 2010
- Last updated
- 22 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Ma GW, Kucey A, Tyagi SC, Papia G, Kucey DS, Varcoe RL, Forbes T, Neville R, Dueck AD, Kayssi A. The role of sealants for achieving anastomotic hemostasis in vascular surgery. Cochrane Database Syst Rev. 2024 May 2;5(5):CD013421. doi: 10.1002/14651858.CD013421.pub2.
PubMed 38695613
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Single-Blind, Controlled, Comparative Efficacy and Safety and Study of Topical Fibrocaps™ and Gelatin Sponge in Surgical Hemostasis in the Netherlands
- ClinicalTrials.gov ID
- NCT01256190
- Acronym / sponsor ID
- FC-002 NL
- Conditions
- Postoperative Hemorrhage
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- MallinckrodtIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 8 Dec 2010 (estimated)
- Results
- Posted 15 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multi-center, prospective, randomized, single-blind, controlled, comparative efficacy and safety trial in subjects undergoing open liver resection surgery. The study will enroll 42 eligible subjects and be conducted at 4 sites in the Netherlands.
Detailed description
This will be a multi-center, prospective, randomized, single-blind, controlled, comparative efficacy and safety trial in 60 subjects undergoing hepatic resection. Subjects will be randomized in a 2:1 ratio to Fibrocaps + Gelfoam or Gelfoam on the day of surgery.
The Fibrospray device will be used to apply Fibrocaps to the Target Bleeding Site. All investigators using the Fibrospray device will be trained on the correct and safe set-up and use of Fibrocaps and the Fibrospray device prior to participating in this clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fibrocaps + Gelatin sponge | Experimental | Biological: Fibrocaps (fibrin sealant), Device: Gelatin spongeTopical Fibrocaps powder followed by application of gelatin sponge |
| Gelatin Sponge | Active comparator | Device: Gelatin spongeapproved device for surgical bleeding |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female ≥ 18 years of age
- Subjects who are able and willing to provide written and signed informed consent
- Willing to use a medically accepted form of contraception from the time of consent to completion of all follow-up study visits
- Has a life expectancy of at least one year
- Presence of mild or moderate bleeding/oozing and control by conventional surgical techniques including but not limited to suture, ligature, and cautery is ineffective or impractical
Key exclusion criteria (10 listed)
- Pregnant or lactating women
- Has a known intolerance to blood products or to Fibrocaps components
- Unwilling to receive human blood products
- Subject has a known allergy to porcine gelatin
- Has a mental or physical condition that would, in the opinion of the Investigator, place the subject at an unacceptable risk or render the subject unable to meet the requirements of the protocol
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 |
|---|---|---|
| Fibrocaps (fibrin sealant)Also: PRO-0601, Fibrin Sealanthuman thrombin and fibrinogen topical powder | Biological | Fibrocaps + Gelatin sponge |
| Gelatin spongeAlso: Spongostanabsorbable gelatin sponge for topical use | Device | Fibrocaps + Gelatin sponge, Gelatin Sponge |
Primary outcome
Time to Hemostasis
Time frame: 0-10 minutes
Time from application of treatment to cessation of bleeding
4 secondary outcomes
Safety
Time frame: 28 days
Incidence of Hemostasis at 5 Minutes
Time frame: 5 minutes
Number of Subjects Achieving Hemostasis at 3 Minutes
Time frame: 3 minutes
Number of Patients Achieving Hemostasis at 10 Minutes
Time frame: 10 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38695613Ma GW, Kucey A, Tyagi SC, Papia G, Kucey DS, Varcoe RL, Forbes T, Neville R, Dueck AD, Kayssi A. The role of sealants for achieving anastomotic hemostasis in vascular surgery. Cochrane Database Syst Rev. 2024 May 2;5(5):CD013421. doi: 10.1002/14651858.CD013421.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.
Paul Frohna, MD, PhD study director
Mallinckrodt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fibrocaps (fibrin sealant) and Gelatin sponge in people with Postoperative Hemorrhage, run by Mallinckrodt at 1 site in Netherlands.
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 10 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 22 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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 15 May 2014). 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?
Time to Hemostasis (time frame: 0-10 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 NCT01256190, 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 22 Aug 2016.