Surgical Blood LossPhase 3REPLACENCT01475669
Study of Fibrinogen Concentrate (Human) (FCH) to Control Bleeding During Complex Cardiovascular Surgery
A Phase 3 study testing Fibrinogen Concentrate (Human) (FCH) in people with Surgical Blood Loss and Postoperative Blood Loss, run by CSL Behring at 35 sites in 11 countries.
Trial summary
The purpose of this study is to demonstrate that Fibrinogen Concentrate (Human)(FCH) can reduce the amount of donor blood products needed during complex cardiovascular surgery, and that it is safe and well tolerated. Subjects in this study will get either a FCH or placebo infusion during surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Blood Loss, Postoperative Blood Loss
- What is being tested?
- Fibrinogen Concentrate (Human) (FCH)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- 35 sitesin 11 countries
- Study dates
- Jan 2012to Sep 2014
- 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
- At Screening:
- Undergoing elective open surgical procedures on any part of the aorta requiring cardiopulmonary bypass (CPB), with or without other cardiac surgical procedures (e.g. valve replacement or repair, coronary artery bypass grafting, etc.).
- 18 years of age or older.
- Written informed consent for study participation obtained before undergoing any study specific procedures.
- Intraoperative (at the 1st 5-minute bleeding mass):
- A 5-minute bleeding mass of 60 to 250 g following discontinuation of CPB, administration of protamine, and establishment of surgical hemostasis.
Show all 9Show fewer
- Minimum core body temperature 35°C, measured according to local practice.
- Activated clotting time ± 25% of baseline levels.
- Blood pH > 7.3.
Who cannot join
- At Screening and/or baseline:
- Undergoing emergency aortic repair surgery.
- Reoperative aortic surgery at the same anatomic site as the original procedure such as replacement of a previously placed aortic graft. Resternotomy and rethoracotomy are permitted.
- Any operation for infection.
- Proof or suspicion of a congenital or acquired coagulation disorder (e.g. Von Willebrand's disease, hemophilia or severe liver disease) or a prothrombotic disorder (e.g. protein C or S deficiency).
- Myocardial infarction (MI), acute coronary syndrome or stroke in the 2 months preceding study surgery.
Show all 14Show fewer
- Low molecular weight or unfractionated heparin in the 24 hours preceding study surgery.
- Clopidogrel administration within 5 days preceding study surgery or prasugrel administration within 7 days preceding study surgery or ticagrelor administration in the 48 hours preceding study surgery.
- Factor Xa inhibitors within 2 days preceding study surgery.
- IIb/IIIa antagonist administration in the 24 hours preceding study surgery.
- Use of direct thrombin inhibitors: within 3 days preceding study surgery for dabigatran and within 24 hours preceding study surgery for all others.
- An international normalized ratio > 1.3 immediately preceding the start of surgery.
- Intraoperative (at the 1st 5-minute bleeding mass):
- Use of any systemic hemostatic therapy (such as FFP, platelets, prothrombin complex concentrates) from the beginning of surgery until IMP administration.
Trial locations and contacts
35 sites in 11 countries.
35 sites in 11 countries
Japan9 sites
Hamamatsu University Hospital
Hamamatsu, Higashi-ku, 431-3192
Kobe University Hospital
Kobe, Hyōgo, 650-0017
Kurume University Hospital
Kurume, Fukuoka, 830-0011
Kyoto University Hospital
Kyoto, Kamigyo-ku, 602-8566
Nagoya University Hospital
Nagoya, Aichi-ken, 466-8560
Tohoku University Hospital
Sendai, Miyagi, 980-8574
Keio University Hospital
Shinjuku, 160-8582
National Cerebral and Cardiovascular Center
Suita, Osaka, Osaka, 565-8565
Tenri Hospital
Tenri, Nara, 632-8552
Canada6 sites
Hamilton Health Science
Hamilton, Ontario, L8L 2X2
Ottawa General Hospital
Ottawa, Ontario, K1H 8L6
Universite Laval - Cardiologie et de Pneumologie de Quebec
Sainte-Foy, Quebec, G1V 4G5
University of Toronto - St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Toronto General Hospital
Toronto, Ontario, M5G 2C4
Providence Health-St Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
United Kingdom4 sites
Papworth Hospital
Cambridge, CB23 3RE
University Hospital of Leicester
Leicester, LE3 9QT
Liverpool Heart and Chest Hospital
Liverpool, L14 3PE
Southampton General Hospital
Southampton, SO16 6YD
Germany3 sites
Study Site
Bielefeld/Hannover
Klinikum der J.-W.-Goethe-Universität
Frankfurt am Main, Hesse, 60590
Klinikum der Universität München
Munich, Bavaria, 81377
Italy3 sites
Policlinico S. Orsola Malpighi
Bologna
Fondazione Centro San Raffaele
Milan, 20132
Azienda Ospedaliera di Udine
Udine, 33100
Poland3 sites
Krakowski Szpital Specjalistyczny im. Jana Pawla II
Krakow, 31-202
Samodzielny Publiczny Szpital Kliniczny nr 2
Szczecin, 70-111
Inst. Kardiologii im. Prymasa Tysiaclecia Kard. S. Wyszynskiego
Warszawa - Anin, Masovian Voivodeship, 04-628
Brazil2 sites
Fundacao Universitaria de Cardiologia - Instituto de Cardiol
Porto Alegre, Rio Grande do Sul, 90620001
InCor
São Paulo, São Paulo, 05403-000
Czechia2 sites
University Hospital St. Anna Brno
Brno, 65691
Fakultni nemocnice Ostrava
Ostrava - Poruba, 708 52
Austria1 site
Allgemeines Krankenhaus der Stadt Wien - Universitätskliniken
Vienna, A-1090
Denmark1 site
Kobenhavns Universitet-Det Sundhedsvidenskabelige Fakultet
Copenhagen, 2200
About this study
Official title: REPLACE (Randomized Evaluation of Fibrinogen Versus Placebo in Complex Cardiovascular Surgery): a Prospective, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Study for the Use of Fibrinogen Concentrate (Human) (FCH) in Complex Cardiovascular Surgery
The purpose of this study is to demonstrate that Fibrinogen Concentrate (Human)(FCH) can reduce the amount of donor blood products needed during complex cardiovascular surgery, and that it is safe and well tolerated. Subjects in this study will get either a FCH or placebo infusion during surgery. This will be in addition to the standard treatment, which is donor blood or blood products. Placebo does not contain any effective medicine.
The study is randomised. This means that the likelihood that subjects will get FCH or placebo is 50%. To make the comparison between FCH and placebo as fair as possible, the study is "double blind". This means that neither the subjects nor the study doctor will know if FCH or placebo is administered. If necessary, the study doctor can find out which treatment the subjects are receiving.
- Conditions
- Surgical Blood Loss, Postoperative Blood Loss
- Being tested
- Fibrinogen Concentrate (Human) (FCH), Placebo
- Medical subject headings
- Blood Loss, Surgical, Postoperative Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibrinogen Concentrate (Human) (FCH)Biological
Single dose infused intravenously within 5 minutes of the completion of the measurement of the 5-minute bleeding mass; the dose is determined individually based on the measured maximum clot firmness (MCF) and subject body weight
PlaceboBiological
Single dose of sodium chloride solution infused intravenously within 5 minutes at a volume equivalent to that needed for FCH
| Study group | Role | What they receive |
|---|---|---|
| Fibrinogen Concentrate (Human) | Experimental | Not described Receives: Biological: Fibrinogen Concentrate (Human) (FCH) |
| Placebo | Placebo comparator | Not described Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total units of allogeneic blood products
Number of units administered of all allogeneic blood products combined (fresh frozen plasma, platelets, and red blood cells)
Measured: Up to 24 hours after investigational medicinal product (IMP) administration
Secondary outcomes (22)
Total avoidance of allogeneic blood transfusions
Number of subjects who are alive and do not have any administration of platelets, fresh frozen plasma (FFP), and red blood cells (RBCs) during the first 24 hours after administration of IMP
Measured: 24 hours after IMP administration
Quantity of blood loss (6 hours)
Blood drainage volume from the chest
Measured: 6 hours after skin closure
Quantity of blood loss (12 hours)
Blood drainage volume from the chest
Measured: 12 hours after skin closure
Quantity of blood loss (24 hours)
Blood drainage volume from the chest
Measured: 24 hours after skin closure
Change in bleeding mass
The 5-minute bleeding mass is measured as the difference in weight of surgical swabs after 5 minutes of surgical packing of the aortic surgical site.
Measured: Immediately before and 5 minutes after completion of IMP administration
Mortality (Day 10)
Mortality with adjudicated cause of death up to 10 days after surgery
Measured: Up to 10 days after surgery
Mortality (Day 30)
Mortality with adjudicated cause of death up to 30 days after surgery
Measured: Up to 30 days after surgery
FFP consumption (24 hours)
Measured: 24 hours after IMP administration
FFP consumption (10 days)
Measured: 10 days after IMP administration
Platelet consumption (24 hours)
Measured: 24 hours after IMP administration
Platelet consumption (10 days)
Measured: 10 days after IMP administration
Red blood cells (RBC) consumption (24 hours)
Measured: 24 hours after IMP administration
RBC consumption (10 days)
Measured: 10 days after IMP administration
Total units of all allogeneic blood products (6 hours)
Number of units of all allogeneic blood products combined (FFP, platelets, and/or RBCs) administered during the first 6 hours after administration of IMP
Measured: 6 hours after IMP administration
Total units of all allogeneic blood products (12 hours)
Number of units of all allogeneic blood products combined (FFP, platelets, and/or RBCs) administered during the first 12 hours after administration of IMP
Measured: 12 hours after IMP administration
Volume of all allogeneic blood products (6 hours)
Volume of all allogeneic blood products combined (FFP, platelets, and/or RBCs) administered during the first 6 hours after administration of IMP
Measured: 6 hours after IMP administration
Volume of all allogeneic blood products (12 hours)
Volume of all allogeneic blood products combined (FFP, platelets, and/or RBCs) administered during the first 12 hours after administration of IMP
Measured: 12 hours after IMP administration
Volume of all allogeneic blood products (24 hours)
Volume of all allogeneic blood products combined (FFP, platelets, and/or RBCs) administered during the first 24 hours after administration of IMP
Measured: 24 hours after IMP administration
Time from administration of study drug to completion of skin closure
Measured: Average 2 hours
Mortality (24 hours)
Mortality with adjudicated cause of death during the first 24 hours after administration of IMP
Measured: WIthin 24 hours after IMP administration
Peak plasma concentration of fibrinogen (Cmax)
Measured: At up to 10 time points from baseline and up to Day 11 after surgery.
Maximum clot firmness
Measured: At baseline; on the day of surgery at: 30 min before CPB, the 1st 5 min bleeding mass, the end of IMP infusion, the 2nd 5-min bleeding mass, and closure; and on Day 2, 3, 4 and at the end of the study (discharge/Day 11 or at discontinuation if earlier).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2011 (estimated)
- Study startJan 2012
- Primary completionJul 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Surgical Blood LossStudies of the same condition, open and under way.
- More trials run by CSL BehringThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSL Behring
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Niels Rahe-Meyer, MD, PhD, Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01475669
- Sponsor's protocol ID
- BI3023_3002
- Other IDs
- 2011-002685-20
- Acronym
- REPLACE
- Status last verified
- Sep 2014
- First submitted
- 17 Nov 2011
- Last updated
- 18 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rahe-Meyer N, Levy JH, Mazer CD, Schramko A, Klein AA, Brat R, Okita Y, Ueda Y, Schmidt DS, Gill R. Randomized evaluation of fibrinogen versus placebo in complex cardiovascular surgery: post hoc analysis and interpretation of phase III results. Interact Cardiovasc Thorac Surg. 2019 Apr 1;28(4):566-574. doi: 10.1093/icvts/ivy302.
PubMed 30462259Rahe-Meyer N, Levy JH, Mazer CD, Schramko A, Klein AA, Brat R, Okita Y, Ueda Y, Schmidt DS, Ranganath R, Gill R. Randomized evaluation of fibrinogen vs placebo in complex cardiovascular surgery (REPLACE): a double-blind phase III study of haemostatic therapy. Br J Anaesth. 2016 Jul;117(1):41-51. doi: 10.1093/bja/aew169.
PubMed 27317703
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REPLACE (Randomized Evaluation of Fibrinogen Versus Placebo in Complex Cardiovascular Surgery): a Prospective, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Study for the Use of Fibrinogen Concentrate (Human) (FCH) in Complex Cardiovascular Surgery
- ClinicalTrials.gov ID
- NCT01475669
- Acronym / sponsor ID
- REPLACE / BI3023_3002
- Conditions
- Surgical Blood Loss, Postoperative Blood Loss
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- CSL BehringIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 21 Nov 2011 (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.
The purpose of this study is to demonstrate that Fibrinogen Concentrate (Human)(FCH) can reduce the amount of donor blood products needed during complex cardiovascular surgery, and that it is safe and well tolerated. Subjects in this study will get either a FCH or placebo infusion during surgery. This will be in addition to the standard treatment, which is donor blood or blood products. Placebo does not contain any effective medicine.
The study is randomised. This means that the likelihood that subjects will get FCH or placebo is 50%. To make the comparison between FCH and placebo as fair as possible, the study is "double blind". This means that neither the subjects nor the study doctor will know if FCH or placebo is administered. If necessary, the study doctor can find out which treatment the subjects are receiving.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fibrinogen Concentrate (Human) | Experimental | Biological: Fibrinogen Concentrate (Human) (FCH) |
| Placebo | Placebo comparator | Biological: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Undergoing elective open surgical procedures on any part of the aorta requiring cardiopulmonary bypass (CPB), with or without other cardiac surgical procedures (e.g. valve replacement or repair, coronary artery bypass grafting, etc.).
- 18 years of age or older.
- Written informed consent for study participation obtained before undergoing any study specific procedures.
- A 5-minute bleeding mass of 60 to 250 g following discontinuation of CPB, administration of protamine, and establishment of surgical hemostasis.
- Minimum core body temperature 35°C, measured according to local practice.
Key exclusion criteria (14 listed)
- Undergoing emergency aortic repair surgery.
- Reoperative aortic surgery at the same anatomic site as the original procedure such as replacement of a previously placed aortic graft. Resternotomy and rethoracotomy are permitted.
- Any operation for infection.
- Proof or suspicion of a congenital or acquired coagulation disorder (e.g. Von Willebrand's disease, hemophilia or severe liver disease) or a prothrombotic disorder (e.g. protein C or S deficiency).
- Myocardial infarction (MI), acute coronary syndrome or stroke in the 2 months preceding study surgery.
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 |
|---|---|---|
| Fibrinogen Concentrate (Human) (FCH)Single dose infused intravenously within 5 minutes of the completion of the measurement of the 5-minute bleeding mass; the dose is determined individually based on the measured maximum clot firmness (MCF) and subject body weight | Biological | Fibrinogen Concentrate (Human) |
| PlaceboSingle dose of sodium chloride solution infused intravenously within 5 minutes at a volume equivalent to that needed for FCH | Biological | Placebo |
Primary outcome
Total units of allogeneic blood products
Time frame: Up to 24 hours after investigational medicinal product (IMP) administration
Number of units administered of all allogeneic blood products combined (fresh frozen plasma, platelets, and red blood cells)
22 secondary outcomes
Total avoidance of allogeneic blood transfusions
Time frame: 24 hours after IMP administration
Quantity of blood loss (6 hours)
Time frame: 6 hours after skin closure
Quantity of blood loss (12 hours)
Time frame: 12 hours after skin closure
Quantity of blood loss (24 hours)
Time frame: 24 hours after skin closure
Change in bleeding mass
Time frame: Immediately before and 5 minutes after completion of IMP administration
Mortality (Day 10)
Time frame: Up to 10 days after surgery
Mortality (Day 30)
Time frame: Up to 30 days after surgery
FFP consumption (24 hours)
Time frame: 24 hours after IMP administration
FFP consumption (10 days)
Time frame: 10 days after IMP administration
Platelet consumption (24 hours)
Time frame: 24 hours after IMP administration
Platelet consumption (10 days)
Time frame: 10 days after IMP administration
Red blood cells (RBC) consumption (24 hours)
Time frame: 24 hours after IMP administration
RBC consumption (10 days)
Time frame: 10 days after IMP administration
Total units of all allogeneic blood products (6 hours)
Time frame: 6 hours after IMP administration
Total units of all allogeneic blood products (12 hours)
Time frame: 12 hours after IMP administration
Volume of all allogeneic blood products (6 hours)
Time frame: 6 hours after IMP administration
Volume of all allogeneic blood products (12 hours)
Time frame: 12 hours after IMP administration
Volume of all allogeneic blood products (24 hours)
Time frame: 24 hours after IMP administration
Time from administration of study drug to completion of skin closure
Time frame: Average 2 hours
Mortality (24 hours)
Time frame: WIthin 24 hours after IMP administration
Peak plasma concentration of fibrinogen (Cmax)
Time frame: At up to 10 time points from baseline and up to Day 11 after surgery.
Maximum clot firmness
Time frame: At baseline; on the day of surgery at: 30 min before CPB, the 1st 5 min bleeding mass, the end of IMP infusion, the 2nd 5-min bleeding mass, and closure; and on Day 2, 3, 4 and at the end of the study (discharge/Day 11 or at discontinuation if earlier).
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 18 Sep 2014.
- Derived from this study: PubMed 30462259Rahe-Meyer N, Levy JH, Mazer CD, Schramko A, Klein AA, Brat R, Okita Y, Ueda Y, Schmidt DS, Gill R. Randomized evaluation of fibrinogen versus placebo in complex cardiovascular surgery: post hoc analysis and interpretation of phase III results. Interact Cardiovasc Thorac Surg. 2019 Apr 1;28(4):566-574. doi: 10.1093/icvts/ivy302.
- Derived from this study: PubMed 27317703Rahe-Meyer N, Levy JH, Mazer CD, Schramko A, Klein AA, Brat R, Okita Y, Ueda Y, Schmidt DS, Ranganath R, Gill R. Randomized evaluation of fibrinogen vs placebo in complex cardiovascular surgery (REPLACE): a double-blind phase III study of haemostatic therapy. Br J Anaesth. 2016 Jul;117(1):41-51. doi: 10.1093/bja/aew169.
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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.
Niels Rahe-Meyer, MD, PhD principal investigator
Hannover Medical School
35 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fibrinogen Concentrate (Human) (FCH) in people with Surgical Blood Loss and Postoperative Blood Loss, run by CSL Behring at 35 sites in 11 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 9 inclusion and 14 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 18 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in Japan, Canada, United Kingdom, Germany, Italy and 6 more countries. 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. Some participants in this study may receive a placebo. 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?
Total units of allogeneic blood products (time frame: Up to 24 hours after investigational medicinal product (IMP) administration). 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 NCT01475669, which also lists 2 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 18 Sep 2014.