Reversal of Dabigatran Anticoagulant Effect With Idarucizumab
- Registration Number
- NCT02104947
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Evaluate the reversal of the anticoagulant effects of dabigatran by IV administration of 5.0g idarucizumab in patients treated with dabigatran etexilate who have uncontrolled bleeding or require emergency surgery or procedures.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 503
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description idarucizumab idarucizumab idarucizumab Only 1 treatment, no placebo or comparator
- Primary Outcome Measures
Name Time Method Maximum Reversal of Anticoagulant Effect of Dabigatran Based on Central Laboratory Determination of dTT or ECT from the end of the first infusion up to 4 hours after the last infusion on Day 1 Maximum reversal of anticoagulant effect of dabigatran based on central laboratory determination of diluted thrombin time (dTT) or ecarin clotting time (ECT), at any time point from the end of the first infusion up to 4 hours after the last infusion.
Reversal is defined for patients with at least one post-dose coagulation test results and pre-dose result higher than 100% ULN (evaluable patients).
Reversal is calculated as 100\* (pre-dose value minus post dose value)/(pre-dose value minus 100% x ULN); if calculated reversal is \> 100, it was set to 100.
- Secondary Outcome Measures
Name Time Method Reversal of aPTT and TT From Central Laboratory from the end of the first infusion up to 4 hours after the last infusion on Day 1 Reversal of anticoagulation as measured by Activated Partial Thromboplastin Time (aPTT) and Thrombin time (TT), at any time point since the end of first infusion up to 4 hours after the completion of the last infusion. Reversal is defined for patients with at least one post-dose coagulation test results and pre-dose result higher than 100% ULN (evaluable patients).
Reversal is calculated as 100\* (pre-dose value minus post dose value)/(pre-dose value minus 100% x ULN); if calculated reversal is \> 100, it was set to 100.Duration of Reversal from the first infusion up to 24 hours after the last infusion on Day 1 Duration of reversal, defined as the time period a patient remained completely reversed based on dTT or ECT, up to 24 hours or re-starting the treatment of dabigatran.
Occurrence of Major/Life-threatening/Fatal Bleeding (for Group B Only) Intraoperatively within 24 hours of surgery Occurrence of major/life-threatening/fatal bleeding (for group B only) intraoperatively and up to 24 hours post-surgery were classified according to major or life-threatening bleeding (ISTH \[International Society for Thrombosis and Hemostasis\] definition). 95% Confidence Interval (CI) is from Clopper-Pearson method.
Time to Cessation of Bleeding (for Group A Only) from the first infusion up to 24 hours after the last infusion on Day 1 Time to cessation of bleeding (for Group A only) since first infusion up to 24 hours after the completion of second infusion; bleeding status was to be categorized before and at several time points after treatment.
Cmin,1 of Unbound Sum (Free) Dabigatran Since the end of first vial of idarucizumab up to 4 hours after the completion of second vial Cmin,1 (Minimum concentrations at any time point since the end of first vial of idarucizumab up to 4 hours after the completion of second vial) of unbound sum (free) dabigatran, provided that two vials given not more than 15 min apart in group A and B.
Reversal of Anticoagulation as Measured by Diluted Thrombin Time (dTT) or Ecarin Clotting Time (ECT) After the First Vial of Idarucizumab and Before the Start of Second Vial after the first vial of idarucizumab and before the start of second vial on Day1 Reversal of anticoagulation as measured by diluted Thrombin Time (dTT) or Ecarin Clotting Time (ECT) after the first vial of idarucizumab and before the start of second vial.
Reversal is defined for patients with at least one post-dose coagulation test results and pre-dose result higher than 100% ULN (evaluable patients). Reversal is calculated as 100\*(pre-dose value minus post dose value)/(pre-dose value minus 100% x ULN); if calculated reversal is \> 100, it was set to 100.
Trial Locations
- Locations (176)
IU Health Methodist Hospital
🇺🇸Indianapolis, Indiana, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
UZ Leuven
🇧🇪Leuven, Belgium
Oslo Universitetssykehus HF, Ullevål sykehus
🇳🇴Oslo, Norway
Kepler Univ. Klinikum Linz
🇦🇹Linz, Austria
Reg.Hosp Kielce,Swietokrzyskie,1.Clinic of Cardiology,Kielce
🇵🇱Kielce, Poland
Univ. Clinic Hosp, Bialystok
🇵🇱Bialystok, Poland
City Pokrovskiy Hospital, Cardiology Dept., Saint Petersburg
🇷🇺Saint Petersburg, Russian Federation
Brussels - UNIV St-Pierre
🇧🇪Brussels, Belgium
Vestre Viken HF, Drammen Sykehus
🇳🇴Drammen, Norway
Sykehuset Østfold Kalnes
🇳🇴Grålum, Norway
Independent Public Healthcare, Dept. of Cardiology, Pulawy
🇵🇱Pulawy, Poland
Centro Hospitalar da Cova da Beira Hospital Pêro da Covilhã
🇵🇹Covilhã, Portugal
Az. Osp. S.Giovanni-Addolorata
🇮🇹Roma, Italy
Baptist Medical Center
🇺🇸Jacksonville, Florida, United States
Baptist Health Center for Clinical Research
🇺🇸Little Rock, Arkansas, United States
St. Mary Medical Center
🇺🇸Langhorne, Pennsylvania, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
St. Vincents Hospital (MEL)
🇦🇺Fitzroy, Victoria, Australia
AKH - Medical University of Vienna
🇦🇹Wien, Austria
B.M. Birla Heart research Centre
🇮🇳Kolkatta, India
St James's Hospital
🇮🇪Dublin, Ireland
Policlinico Gemelli
🇮🇹Roma, Italy
Azienda Ospedaliera Careggi
🇮🇹Firenze, Italy
Ospedale S.Maria della Misericordia, AO di Perugia
🇮🇹Perugia, Italy
Ogaki Municipal Hospital
🇯🇵Gifu, Ogaki, Japan
National Hospital Organization Takasaki General Medical Center
🇯🇵Gunma, Takasaki, Japan
HOP Nord
🇫🇷Saint-Priest-en-Jarez, France
Oulun yliopistollinen keskussairaala
🇫🇮Oulu, Finland
Fortis Escorts Heart Institute
🇮🇳New Delhi, India
Vivantes Netzwerk für Gesundheit GmbH
🇩🇪Berlin, Germany
Meir Medical Center
🇮🇱Kfar Saba, Israel
Cork University Hospital
🇮🇪Wilton, Ireland
Hospital Cardiologica Aguascalientes
🇲🇽Aguascalientes, Mexico
Azienda Unità Sanitaria Locale di Reggio Emilia
🇮🇹Reggio Emilia, Italy
Christchurch Hospital
🇳🇿Christchurch, New Zealand
HOP Sainte Anne, Urgence, Toulon
🇫🇷Toulon, France
The Chaim Sheba Medical Center Tel Hashomer
🇮🇱Ramat Gan, Israel
Universitätsmedizin Greifswald
🇩🇪Greifswald, Germany
The Catholic University of Korea, Seoul St.Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Rambam Medical Center
🇮🇱Haifa, Israel
North Shore Hospital, Takapuna
🇳🇿Takapuna Auckland, New Zealand
Radboud Universitair Medisch Centrum
🇳🇱Nijmegen, Netherlands
Maastricht Universitair Medisch Centrum
🇳🇱Maastricht, Netherlands
Waikato Hospital
🇳🇿Hamilton, New Zealand
Middlemore Hospital
🇳🇿Otahuhu South Auckland, New Zealand
Martini Ziekenhuis
🇳🇱Groningen, Netherlands
Erasmus Medisch Centrum
🇳🇱Rotterdam, Netherlands
Haukeland Universitetssykehus
🇳🇴Bergen, Norway
Hospital Ramón y Cajal
🇪🇸Madrid, Spain
Saint Wincenty a Paulo Hosp., Cardiology Dept., Gdynia
🇵🇱Gdynia, Poland
Central Hosp.Minis.Interior,Dep.Noninvasive Cardiol,Warszawa
🇵🇱Warszawa, Poland
CHLO, EPE - Hospital S. Francisco Xavier
🇵🇹Lisboa, Portugal
Hospital General Universitario Gregorio Marañón
🇪🇸Madrid, Spain
Military Medical Academy n.a. S. M. Kirov, St. Petersburg
🇷🇺St. Petersburg, Russian Federation
National University Hospital
🇸🇬Singapore, Singapore
Changi General Hospital
🇸🇬Singapore, Singapore
Hospital General Universitario de Alicante
🇪🇸Alicante, Spain
Centro Hospitalar São João,EPE
🇵🇹Porto, Portugal
Dr. D. Adler
🇿🇦Sandton, South Africa
Sahlgrenska US, Göteborg
🇸🇪Göteborg, Sweden
Hospital Clínic de Barcelona
🇪🇸Barcelona, Spain
The John Paul II Hosp.,Dept.of Coronary Heart Disease,Krakow
🇵🇱Krakow, Poland
Singapore General Hospital
🇸🇬Singapore, Singapore
Hospital Clínico de Valencia
🇪🇸Valencia, Spain
Hospital Clínico Universitario Lozano Blesa
🇪🇸Zaragoza, Spain
Far Eastern Memorial Hospital
🇨🇳New Taipei City, Taiwan
North Hampshire Hospital
🇬🇧Basingstoke, United Kingdom
Emergency Department, John Radcliffe Hospital, Oxford
🇬🇧Oxford, United Kingdom
Taipe Veterans General Hospital
🇨🇳Taipei, Taiwan
Musgrove Park Hospital
🇬🇧Taunton, United Kingdom
Shonan Kamakura General Hospital
🇯🇵Kanagawa, Kamakura, Japan
National Hospital Organization Kagoshima Medical Center
🇯🇵Kagoshima, Kagoshima, Japan
HOP Lyon Sud
🇫🇷Pierre Benite, France
Jewish General Hospital
🇨🇦Montreal, Migration Data, Canada
Hamilton General Hospital
🇨🇦Hamilton, Ontario, Canada
Juravinski Hospital
🇨🇦Hamilton, Ontario, Canada
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
🇩🇪Mainz, Germany
Hospital de Bellvitge
🇪🇸Barcelona, Spain
Hospital Politècnic La Fe
🇪🇸Valencia, Spain
TAYS, Acuta, Tampere
🇫🇮Tampere, Finland
Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
University of Florida College of Medicine
🇺🇸Gainesville, Florida, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
Community Hospital
🇺🇸Munster, Indiana, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
OSF Saint Francis Medical Center
🇺🇸Peoria, Illinois, United States
Our Lady of the Lake Regional Medical Center
🇺🇸Baton Rouge, Louisiana, United States
Mercy Hospital St. Louis
🇺🇸Saint Louis, Missouri, United States
Newton-Wellesley Hospital
🇺🇸Newton, Massachusetts, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Genesys Regional Medical Center
🇺🇸Grand Blanc, Michigan, United States
Henry Ford Allegiance Health
🇺🇸Jackson, Michigan, United States
Miami Valley Hospital
🇺🇸Dayton, Ohio, United States
St. Elizabeth Youngstown Hospital
🇺🇸Youngstown, Ohio, United States
Lankenau Medical Center
🇺🇸Wynnewood, Pennsylvania, United States
Memorial Hermann Hospital - Texas Medical Center
🇺🇸Houston, Texas, United States
Centro Privado de Cardiología
🇦🇷Tucumán, Argentina
Texas Health Research and Education Institute
🇺🇸Fort Worth, Texas, United States
Concord Repatriation General Hospital
🇦🇺Concord, New South Wales, Australia
St George Hospital
🇦🇺Kogarah, New South Wales, Australia
Royal North Shore Hospital
🇦🇺St Leonards, New South Wales, Australia
KH der Barmherzigen Schwestern Linz
🇦🇹Linz, Austria
Flinders Medical Centre
🇦🇺Bedford Park, South Australia, Australia
Wilhelminenspital
🇦🇹Wien, Austria
Aalst - HOSP Onze-Lieve-Vrouw
🇧🇪Aalst, Belgium
Brussels - UNIV UZ Brussel
🇧🇪Brussel, Belgium
Brussels - UNIV St-Luc
🇧🇪Bruxelles, Belgium
Genk - HOSP ZOL (St-Jan)
🇧🇪Genk, Belgium
St. Paul's Hospital
🇨🇦Vancouver, British Columbia, Canada
Hospital Nossa Senhora de Pompéia
🇧🇷Caxias do Sul, Brazil
Fundación Valle del Lili
🇨🇴Cali, Colombia
Centro Médico Imbanaco de Cali S.A.
🇨🇴Cali, Colombia
Hospital Pablo Tobón Uribe
🇨🇴Medellin, Colombia
University Hospital Brno
🇨🇿Brno, Czechia
Fundación Cardiovascular de Colombia
🇨🇴Floridablanca, Colombia
Regional Hospital Liberec
🇨🇿Liberec, Czechia
Hospital Hradec Kralove
🇨🇿Hradec Kralove, Czechia
Hospital,Neurology Dept,Ceske Budejovice
🇨🇿Ceske Budejovice, Czechia
University Hospital Motol
🇨🇿Praha 5, Czechia
Univ. Hospital Kralovske Vinohrady
🇨🇿Praha, Czechia
Keski-Suomen keskussairaala
🇫🇮Jyväskylä, Finland
HUS, Kirurginen päivystysosasto P1P, Meilahti, Helsinki
🇫🇮Helsinki, Finland
Aarhus Universitetshospital
🇩🇰Aarhus C, Denmark
HOP Trousseau
🇫🇷Chambray les tours, France
TYKS, Akuutti sisätautihoito ASIS, Turku
🇫🇮Turku, Finland
HOP Bocage
🇫🇷Dijon, France
HOP André Mignot
🇫🇷Le Chesnay, France
HOP Dupuytren
🇫🇷Limoges, France
HOP Lille, SAMU 59, Lille
🇫🇷Lille cedex, France
HOP Herriot
🇫🇷Lyon, France
HOP Lapeyronie
🇫🇷Montpellier cedex, France
HOP Haut-Lévêque
🇫🇷Pessac, France
Prince of Wales Hospital
🇭🇰Hong Kong, Hong Kong
Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Japanese Red Cross Nagoya Daini Hospital
🇯🇵Aichi, Nagoya, Japan
Ehime Prefectural Central Hospital
🇯🇵Ehime, Matsuyama, Japan
Fukuoka Tokushukai Medical Center
🇯🇵Fukuoka, Kasuga, Japan
Hyogo College of Medicine Hospital
🇯🇵Hyogo, Nishinomiya, Japan
National Cerebral and Cardiovascular Center
🇯🇵Osaka, Suita, Japan
Nippon Medical School Hospital
🇯🇵Tokyo, Bunkyo-Ku, Japan
National Hospital Organization Disaster Medical Center
🇯🇵Tokyo, Tachikawa, Japan
Yamagata City Hospital SAISEIKAN
🇯🇵Yamagata, Yamagata, Japan
Seoul National University Bundang Hospital
🇰🇷Seongnam, Korea, Republic of
OLVG, locatie Oosterpark
🇳🇱Amsterdam, Netherlands
Academisch Medisch Centrum (AMC)
🇳🇱Amsterdam, Netherlands
Auckland City Hospital
🇳🇿Grafton / Auckland, New Zealand
Universitetssykehuset Nord-Norge, Tromsø
🇳🇴Tromsø, Norway
University Clinical Center, Gdansk
🇵🇱Gdansk, Poland
Stefan Kardynal Wyszynski Reg.Hosp,Cardiol&IntensUnit,Lublin
🇵🇱Lublin, Poland
Centro Hospitalar do Porto, EPE
🇵🇹Porto, Portugal
Hospital Universitario Marqués de Valdecilla
🇪🇸Santander, Spain
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
Dr. Engelbrecht
🇿🇦Somerset West, South Africa
Hospital Clínico San Carlos
🇪🇸Madrid, Spain
Hospital La Paz
🇪🇸Madrid, Spain
Hospital Regional Universitario de Málaga
🇪🇸Malaga, Spain
Hospital Álvaro Cunqueiro
🇪🇸Vigo (Pontevedra), Spain
Skånes universitetssjukhus
🇸🇪Lund, Sweden
Akademiska sjukhuset
🇸🇪Uppsala, Sweden
Kaohsiung Medical University Chung-Ho Memorial Hospital
🇨🇳Kaohsiung, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
St George's Hospital
🇬🇧London, United Kingdom
Royal London Hospital
🇬🇧London, United Kingdom
Southampton General Hospital
🇬🇧Southampton, United Kingdom
Westmead Hospital-Clinical Haematology Dept
🇦🇺Westmead, New South Wales, Australia
MedStar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Mayo Clinic Cancer Center
🇺🇸Jacksonville, Florida, United States
St. Joseph's Hospital
🇺🇸Tampa, Florida, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
St. John Health System Inc
🇺🇸Tulsa, Oklahoma, United States
Sentara RMH Medical Center
🇺🇸Harrisonburg, Virginia, United States
Royal Liverpool University Hospital
🇬🇧Liverpool, United Kingdom
Prince of Wales Hosp, Dept of Med & Therapeutics
🇭🇰Hong Kong, Hong Kong
Pamela Youde Nethersole Eastern Hospital
🇭🇰Hong Kong, Hong Kong