Postoperative HemorrhageNCT01256164
U.S. Study of Fibrocaps in Surgical Hemostasis
A study testing Fibrocaps (fibrin sealant) and Gelfoam in people with Postoperative Hemorrhage, run by Mallinckrodt at 1 site in United States.
Trial summary
The purpose of this study was to characterize the safety and hemostatic activity of topical Fibrocaps in surgical patients when control of mild to moderate bleeding by standard surgical techniques was ineffective and/or impractical. 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 Gelfoam
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Oct 2011
- Phase
- Interventional
- 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 or older
- Subjects who are able and willing to provide written and signed informed consent
- All subjects willing to use a medically accepted form of contraception from the time of consent to completion of all follow-up study visits
- A life expectancy of at least one year
- Intra-Operative inclusion criteria
- Presence of mild or moderate bleeding/oozing when control by conventional surgical techniques, including but not limited to suture, ligature and cautery is ineffective or impractical
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- Absence of intraoperative complications other than bleeding which, in the opinion of the investigator, may interfere with the assessment of efficacy or safety
- No intraoperative use of a topical hemostat containing thrombin
- Approximate Target Bleeding Site surface area of no more than 100 square centimeters
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 start of this trial, or is planning participation in another clinical trial during the 4 weeks after surgery
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- 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
- Aspartate Aminotransferase (AST) or Alanine aminotransferase (ALT) 3 times (or more) the upper limit normal range during screening, except for subjects undergoing liver resection surgery where there is no upper limit for these analytes due to the nature of their disease.
- Platelets < 10 x 10^9 /L during screening
- Activated partial thromboplastin time (aPTT) > 100 seconds during screening
- International normalized ratio (INR)greater than 2.5 during screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A U.S. Phase 2, Randomized, Single-Blind, Controlled, Comparative Efficacy and Safety Study of Topical Fibrocaps™ and Gelatin Sponge (USP) in Surgical Hemostasis
The purpose of this study was to characterize the safety and hemostatic activity of topical Fibrocaps in surgical patients when control of mild to moderate bleeding by standard surgical techniques was ineffective and/or impractical.
Read the detailed description
This was a multi-center, prospective, randomized, single-blind, controlled, comparative efficacy and safety trial in 90 subjects undergoing spinal surgery, hepatic resection, specific soft tissue dissection, or peripheral vascular surgery, ((including peripheral artery bypass and arteriovenous graft formation for hemodialysis using either Polytetrafluoroethylene (PTFE) or native grafts)). Subjects were randomized in a 2:1 ratio to Fibrocaps + Gelfoam or Gelfoam on the day of surgery.
Use of the Fibrospray device was optional for spinal and vascular surgeries, but required for the general surgery procedures. All investigators using the Fibrospray device were 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), Gelfoam
- Keywords
- fibrin sealants, hemostatics, time to hemostasis
- 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)Device
Also called Pro-0601
Fibrocaps powder (max dose 1.5g) should be applied directly to the bleeding site or to the Gelfoam and then applied to the bleeding site. Re-application of 1.5 g of Fibrocaps is allowed.
GelfoamDevice
An identified Target Bleeding Site (TBS) should be treated with application of Gelfoam followed by light manual pressure with a sterile gauze.
| Study group | Role | What they receive |
|---|---|---|
| Fibrocaps + Gelfoam | Experimental | After identification of a Target Bleeding Site (TBS), topical Fibrocaps should be applied using the Fibrospray device for general surgeries; and either the Fibrospray device or direct application for spinal and vascular surgeries, followed by application of Gelfoam and manual pressure with sterile gauze. Receives: Device: Fibrocaps (fibrin sealant) |
| Gelfoam | Active comparator | Treatment is Gelfoam followed by manual pressure with sterile gauze. If hemostasis is not achieved within 10 minutes of the Start Time,the subject should be considered a treatment failure and the surgeon should implement additional hemostatic measures. Receives: Device: Gelfoam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Time to Hemostasis (TTH)
Time to hemostasis recorded from the first application of study treatment until 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 TBS
Measured: 28 Days
Number of Subjects Achieving Hemostasis at 3 Minutes
Measured: 3 minutes
Number of Participants Achieving Hemostasis at 5 Minutes
Measured: 5 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 N/A
- 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
- 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
- NCT01256164
- Sponsor's protocol ID
- FC-002
- Status last verified
- Aug 2017
- First submitted
- 6 Dec 2010
- Last updated
- 13 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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 13 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A U.S. Phase 2, Randomized, Single-Blind, Controlled, Comparative Efficacy and Safety Study of Topical Fibrocaps™ and Gelatin Sponge (USP) in Surgical Hemostasis
- ClinicalTrials.gov ID
- NCT01256164
- Acronym / sponsor ID
- FC-002
- Conditions
- Postoperative Hemorrhage
- Keywords
- fibrin sealants, hemostatics, time to hemostasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 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 11 Nov 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 this study was to characterize the safety and hemostatic activity of topical Fibrocaps in surgical patients when control of mild to moderate bleeding by standard surgical techniques was ineffective and/or impractical.
Detailed description
This was a multi-center, prospective, randomized, single-blind, controlled, comparative efficacy and safety trial in 90 subjects undergoing spinal surgery, hepatic resection, specific soft tissue dissection, or peripheral vascular surgery, ((including peripheral artery bypass and arteriovenous graft formation for hemodialysis using either Polytetrafluoroethylene (PTFE) or native grafts)). Subjects were randomized in a 2:1 ratio to Fibrocaps + Gelfoam or Gelfoam on the day of surgery.
Use of the Fibrospray device was optional for spinal and vascular surgeries, but required for the general surgery procedures. All investigators using the Fibrospray device were 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 + Gelfoam | Experimental | Device: Fibrocaps (fibrin sealant)After identification of a Target Bleeding Site (TBS), topical Fibrocaps should be applied using the Fibrospray device for general surgeries; and either the Fibrospray device or direct application for spinal and vascular surgeries, followed by application of Gelfoam and manual pressure with sterile gauze. |
| Gelfoam | Active comparator | Device: GelfoamTreatment is Gelfoam followed by manual pressure with sterile gauze. If hemostasis is not achieved within 10 minutes of the Start Time,the subject should be considered a treatment failure and the surgeon should implement additional hemostatic measures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- male or female 18 years of age or older
- Subjects who are able and willing to provide written and signed informed consent
- All subjects willing to use a medically accepted form of contraception from the time of consent to completion of all follow-up study visits
- A life expectancy of at least one year
- Intra-Operative inclusion criteria
Key exclusion criteria (11 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-0601Fibrocaps powder (max dose 1.5g) should be applied directly to the bleeding site or to the Gelfoam and then applied to the bleeding site. Re-application of 1.5 g of Fibrocaps is allowed. | Device | Fibrocaps + Gelfoam |
| GelfoamAn identified Target Bleeding Site (TBS) should be treated with application of Gelfoam followed by light manual pressure with a sterile gauze. | Device | Gelfoam |
Primary outcome
Mean Time to Hemostasis (TTH)
Time frame: 0-10 minutes
Time to hemostasis recorded from the first application of study treatment until cessation of bleeding
4 secondary outcomes
Safety
Time frame: 28 Days
Number of Subjects Achieving Hemostasis at 3 Minutes
Time frame: 3 minutes
Number of Participants Achieving Hemostasis at 5 Minutes
Time frame: 5 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 13 Sep 2017.
- 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 study testing Fibrocaps (fibrin sealant) and Gelfoam in people with Postoperative Hemorrhage, run by Mallinckrodt at 1 site in United States.
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 9 inclusion and 11 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 13 Sep 2017. 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 United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Nov 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?
Mean Time to Hemostasis (TTH) (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 NCT01256164, 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 13 Sep 2017.