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Surgical BleedingPhase 3NCT02284256

A Safety and Efficacy Study Comparing Fibrocaps and Tachosil in Hepatic Surgery

A Phase 3 study testing Fibrocaps and TachoSil in people with Surgical Bleeding, run by Mallinckrodt at 15 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of the study is to demonstrate the non-inferiority or superiority of Fibrocaps plus gelatin sponge compared to Tachosil when control of mild to moderate bleeding with conventional surgical techniques is ineffective or impractical. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Surgical Bleeding
What is being tested?
Fibrocaps and TachoSil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
15 sitesin 2 countries
Study dates
Nov 2014to Aug 2015
Phase
Phase 3
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

  • Subject has signed an independent ethics committee (IEC)-approved informed consent document
  • Subject is undergoing hepatic wedge resection or anatomic resection of 1 to 5 contiguous hepatic segments, and/or other hepatic surgery, any of which may be combined with other surgical procedures involving the gall bladder or intestines
  • Subject age is >18 years at time of consent
  • If female and of child-bearing potential, subject has negative pregnancy test during screening and is not breast-feeding
  • If subject is a sexually active male or a sexually active female of child-bearing potential, subject agrees to use a medically accepted form of contraception from the time of consent to completion of all follow-up study visits
  • Presence of mild to moderate bleeding/oozing when control by conventional surgical techniques, including but not limited to suture, ligature and cautery is ineffective or impractical
  • Absence of intra-operative complications other than bleeding which, in the opinion of the investigator, may interfere with the assessment of efficacy or safety
  • Approximate TBS surface area of ≤ 100 cm^2

Who cannot join

  • Subject has known hypersensitivity to Fibrocaps or any of its components
  • Subject has known allergy to porcine gelatin
  • Subject has known hypersensitivity to Tachosil or any of the excipients included in Tachosil
  • Subject is unwilling to receive blood products
  • Subject is having hepatic surgery due to emergency-traumatic event
  • Subject requires extrahepatic bile duct resection (common bile duct resection or resection of the bile duct which leads to performing an anastomoses between the bile duct and small bowel) and biliary anastomosis, and/or pancreatic resections
Show all 10Show fewer
  • Subject 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, or baseline abnormalities of international normalized ratio (INR) > 2.5 or activated partial thromboplastin time (aPTT) > 100 seconds during screening that are not explained by current drug treatment (e.g., warfarin, heparin)
  • Subject has a platelet count < 100 x10^9 PLT/L during screening
  • Subject has medical, social or psychosocial factors that, in the opinion of the investigator, could impact safety or compliance with study procedures
  • Subject is 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 within 6 weeks after surgery

Trial locations and contacts

15 sites in 2 countries.

15 sites in 2 countries

Germany12 sites

  • Universitaetsklinikum Aachen, RWTH

    Aachen, 52074

  • Charite Campus Virchow-Klinikum

    Berlin, 13353

  • Krankenhaus Nordwest GmbH

    Frankfurt am Main, D-60488

  • J. W. Goethe Universitaetsklinik Frankfurt

    Frankfurt am Main, D-60590

  • Universitaetsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120

  • Universitaetsklinikum Leipzig AoeR

    Leipzig, 04103

  • Klinikum der LMU Muenchen - Campus Grosshadern

    München, 81377

  • Klinikum Rechts der Isar Munich

    Munich

  • Klinikum Stuttgart - Katharinenhospital (KH)

    Stuttgart

  • Universitaetsklinikum Tuebingen

    Tübingen, 72976

Other trials in Germany

Austria3 sites

  • Universitaetsklinik Innsbruck

    Innsbruck, A-6020

  • Krankenhaus der Barmherzigen Schwestern Linz Betriebsgesellschaft m.b.H.

    Linz, A-4010

  • Medizinische Universitaet Wien AKH

    Vienna, A-1090

Other trials in Austria

About this study

Official title: A Phase 3b, Randomized, Single-Blind, Controlled, Comparative Efficacy and Safety Study of Topical FibrocapsTM (RaplixaTM) and Tachosil® in Surgical Hemostasis During Hepatic Resection

The primary objective of the study is to demonstrate the non-inferiority or superiority of Fibrocaps plus gelatin sponge compared to Tachosil when control of mild to moderate bleeding with conventional surgical techniques is ineffective or impractical.

Being tested
Fibrocaps, TachoSil

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FibrocapsDrug

    Also called Raplixa

  • TachoSilDrug

Study groups in NCT02284256
Study groupRoleWhat they receive
FibrocapsExperimentalHuman fibrinogen and thrombin powder. Single application during surgery Other Names: * Raplixa * PRO-0601 * Fibrin sealant Device: Gelatin sponge. Single application during surgery Other Name: Spongostan
Receives: Drug: Fibrocaps
TachoSilActive comparatorHuman fibrinogen and thrombin powder. Single application during surgery
Receives: Drug: TachoSil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to Hemostasis (TTH)

    Measured: Within 5 minutes of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2014 (estimated)
  2. Study startNov 2014
  3. Primary completionAug 2015
  4. Study completionAug 2015

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Participant
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02284256
Sponsor's protocol ID
FC-005
Other IDs
2014-000816-32, 2014
Status last verified
Aug 2017
First submitted
3 Nov 2014
Last updated
16 Aug 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fibrocaps and TachoSil in people with Surgical Bleeding, run by Mallinckrodt at 15 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 8 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 16 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Time to Hemostasis (TTH) (time frame: Within 5 minutes of treatment). 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 NCT02284256.

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 16 Aug 2017.

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