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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01475669
Other study ID # BI3023_3002
Secondary ID 2011-002685-20
Status Completed
Phase Phase 3
First received November 17, 2011
Last updated September 17, 2014
Start date January 2012
Est. completion date September 2014

Study information

Verified date September 2014
Source CSL Behring
Contact n/a
Is FDA regulated No
Health authority Germany: Paul-Ehrlich-InstitutFinland: Finnish Medicines AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyItaly: Ethics CommitteeAustria: Austrian Medicines and Medical Devices AgencyCanada: Health CanadaIndia: Central Drugs Standard Control OrganizationPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsJapan: Pharmaceuticals and Medical Devices Agency
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 152
Est. completion date September 2014
Est. primary completion date July 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

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.

- Minimum core body temperature 35°C, measured according to local practice.

- Activated clotting time ± 25% of baseline levels.

- Blood pH > 7.3.

Exclusion Criteria:

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.

- 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Biological:
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
Placebo
Single dose of sodium chloride solution infused intravenously within 5 minutes at a volume equivalent to that needed for FCH

Locations

Country Name City State
Austria Allgemeines Krankenhaus der Stadt Wien - Universitätskliniken Vienna
Brazil Fundacao Universitaria de Cardiologia - Instituto de Cardiol Porto Alegre Rio Grande do Sul
Brazil InCor Sao Paulo
Canada Hamilton Health Science Hamilton Ontario
Canada Ottawa General Hospital Ottawa Ontario
Canada Universite Laval - Cardiologie et de Pneumologie de Quebec Sainte Foy Quebec
Canada Toronto General Hospital Toronto Ontario
Canada University of Toronto - St. Michael's Hospital Toronto Ontario
Canada Providence Health-St Paul's Hospital Vancouver British Columbia
Czech Republic University Hospital St. Anna Brno Brno
Czech Republic Fakultni nemocnice Ostrava Ostrava - Poruba
Denmark Kobenhavns Universitet-Det Sundhedsvidenskabelige Fakultet Copenhagen
Finland HUCH Anaestesia and Surgery Helsinki
Germany Study Site Bielefeld/Hannover
Germany Klinikum der J.-W.-Goethe-Universität Frankfurt am Main Hessen
Germany Klinikum der Universität München Munich Bayern
Italy Policlinico S. Orsola Malpighi Bologna
Italy Fondazione Centro San Raffaele Milano
Italy Azienda Ospedaliera di Udine Udine
Japan Hamamatsu University Hospital Hamamatsu Higashi-ku
Japan Kobe University Hospital Kobe Hyogo
Japan Kurume University Hospital Kurume Fukuoka-ken
Japan Kyoto University Hospital Kyoto Kamigyo-ku
Japan Nagoya University Hospital Nagoya Aichi
Japan Tohoku University Hospital Sendai Miyagi
Japan Keio University Hospital Shinjuku
Japan National Cerebral and Cardiovascular Center Suita, Osaka Osaka
Japan Tenri Hospital Tenri Nara
Poland Krakowski Szpital Specjalistyczny im. Jana Pawla II Krakow
Poland Samodzielny Publiczny Szpital Kliniczny nr 2 Szczecin
Poland Inst. Kardiologii im. Prymasa Tysiaclecia Kard. S. Wyszynskiego Warszawa - Anin Mazowieckie
United Kingdom Papworth Hospital Cambridge
United Kingdom University Hospital of Leicester Leicester
United Kingdom Liverpool Heart and Chest Hospital Liverpool
United Kingdom Southampton General Hospital Southampton

Sponsors (1)

Lead Sponsor Collaborator
CSL Behring

Countries where clinical trial is conducted

Austria,  Brazil,  Canada,  Czech Republic,  Denmark,  Finland,  Germany,  Italy,  Japan,  Poland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total units of allogeneic blood products Number of units administered of all allogeneic blood products combined (fresh frozen plasma, platelets, and red blood cells) Up to 24 hours after investigational medicinal product (IMP) administration No
Secondary 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 24 hours after IMP administration No
Secondary Quantity of blood loss (6 hours) Blood drainage volume from the chest 6 hours after skin closure No
Secondary Quantity of blood loss (12 hours) Blood drainage volume from the chest 12 hours after skin closure No
Secondary Quantity of blood loss (24 hours) Blood drainage volume from the chest 24 hours after skin closure No
Secondary 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. Immediately before and 5 minutes after completion of IMP administration No
Secondary Mortality (Day 10) Mortality with adjudicated cause of death up to 10 days after surgery Up to 10 days after surgery No
Secondary Mortality (Day 30) Mortality with adjudicated cause of death up to 30 days after surgery Up to 30 days after surgery No
Secondary FFP consumption (24 hours) 24 hours after IMP administration No
Secondary FFP consumption (10 days) 10 days after IMP administration No
Secondary Platelet consumption (24 hours) 24 hours after IMP administration No
Secondary Platelet consumption (10 days) 10 days after IMP administration No
Secondary Red blood cells (RBC) consumption (24 hours) 24 hours after IMP administration No
Secondary RBC consumption (10 days) 10 days after IMP administration No
Secondary 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 6 hours after IMP administration No
Secondary 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 12 hours after IMP administration No
Secondary 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 6 hours after IMP administration No
Secondary 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 12 hours after IMP administration No
Secondary 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 24 hours after IMP administration No
Secondary Time from administration of study drug to completion of skin closure Average 2 hours No
Secondary Mortality (24 hours) Mortality with adjudicated cause of death during the first 24 hours after administration of IMP WIthin 24 hours after IMP administration No
Secondary Peak plasma concentration of fibrinogen (Cmax) At up to 10 time points from baseline and up to Day 11 after surgery. No
Secondary Maximum clot firmness 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). No
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