Myocardial Ischemia and Transfusion

Who is this study for? Adult patients with Myocardial Infarction
What treatments are being studied? Red Blood Cell Transfusion
Status: Recruiting
Location: See all (132) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purpose of this study is to compare two red blood cell transfusion strategies (liberal and restrictive) for patients who have had an acute myocardial infarction and are anemic.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• 18 years of age or older

• Either ST segment elevation myocardial infarction or Non ST segment elevation myocardial infarction consistent with the 3rd Universal Definition of Myocardial Infarction criteria that occurs on admission or during the index hospitalization

• Hemoglobin concentration less than 10 g/dL at the time of random allocation

• Patient physician believes that both of the transfusion strategies are consistent with good medical care for the patient

Locations
United States
Arkansas
Central Arkansas Veterans Healthcare System
Recruiting
Little Rock
University of Arkansas Medical Sciences (UAMS) Hospital
Recruiting
Little Rock
California
VAGLAHS
Completed
Los Angeles
Connecticut
Danbury Hospital
Completed
Danbury
Illinois
Rush University Medical Center
Recruiting
Chicago
University of Chicago Medical Center
Recruiting
Chicago
Alexian Brothers Medical Center
Recruiting
Elk Grove Village
AMITA Health
Recruiting
Hinsdale
Kansas
Saint Luke's Mid America Heart
Recruiting
Kansas City
Kentucky
University of Louisville
Recruiting
Louisville
Louisiana
Tulane University School of Medicine
Completed
New Orleans
Massachusetts
Beth Israel Deaconess Medical Center
Recruiting
Boston
Boston Medical Center
Recruiting
Boston
Massachusetts General Hospital
Completed
Boston
Lahey Hospital
Completed
Burlington
Michigan
University of Michigan
Recruiting
Ann Arbor
St. Joseph Mercy Health System
Recruiting
Ypsilanti
Minnesota
Essentia Health
Completed
Duluth
Minneapolis Heart Institute (Foundation)
Recruiting
Minneapolis
University of Minnesota Medical Center Fairview
Completed
Minneapolis
Mayo Clinic
Recruiting
Rochester
Missouri
Washington University
Recruiting
Saint Louis
Mississippi
Memorial Hospital at Gulfport
Recruiting
Gulfport
North Carolina
The University of North Carolina at Chapel Hill
Recruiting
Chapel Hill
Durham Va
Recruiting
Durham
WakeMed Health and Hospital
Recruiting
Raleigh
New Jersey
Copper University Hospital
Recruiting
Camden
Hackensacjk University Medical Center
Recruiting
Hackensack
Jersey Shore University Medical
Recruiting
Neptune
Robert Wood Johnson University Hospital
Recruiting
New Brunswick
New Mexico
University of New Mexico
Recruiting
Albuquerque
New York
Albany Medical College
Recruiting
Albany
Southside Hospital
Recruiting
Bay Shore
Montefiore Medical Center
Recruiting
Bronx
NYP Brooklyn Methodist
Recruiting
Brooklyn
New York Presbyterian/Queens
Recruiting
Flushing
Westchester Medical Center
Recruiting
Hawthorne
North Shore University Hospital
Recruiting
Manhasset
Northern Westchester Hospital
Recruiting
Mount Kisco
Lenox Hilll Hospital
Recruiting
New York
NYU Langone Medical Center, Bellevue Hospital
Recruiting
New York
Rochester General Hospital
Recruiting
Rochester
University of Rochester
Completed
Rochester
Northwell Staten Island Hopsital
Recruiting
Staten Island
Stony Brook Medicine
Recruiting
Stony Brook
Ohio
Aultman Hospital
Recruiting
Canton
University of Toledo Medical Center
Recruiting
Toledo
Pennsylvania
Lancaster General Hospital
Recruiting
Lancaster
PENN Presbyterian Medical Cente
Recruiting
Philadelphia
Thomas Jefferson University
Recruiting
Philadelphia
University of Pittsburgh Medical Center
Recruiting
Pittsburgh
Lankenau Medical Center
Recruiting
Wynnewood
Rhode Island
Rhode Island Hospital
Recruiting
Providence
The Miriam Hospital
Recruiting
Providence
South Carolina
Greenville Health System
Completed
Greenville
Tennessee
The Memphis VAMC
Recruiting
Memphis
Texas
Baylor St Luke's Medical Center
Recruiting
Houston
Virginia
Virginia Commonwealth University
Recruiting
Richmond
Vermont
University of Vermont Medical Center
Recruiting
Burlington
Wisconsin
Medical College of Wisconsin - Froedtert Hospital
Recruiting
Milwaukee
Other Locations
Australia
Flinders Medical Centre
Recruiting
Bedford Park
Concord Repatriation General Hospital
Recruiting
Concord
Gosford Hospital
Recruiting
Gosford
Royal Perth Hospital
Recruiting
Perth
Brazil
Hospital Felício Rocho
Recruiting
Belo Horizonte
Instituto de Ensino e Pesquisa do Hospital do Coração do Brasil
Recruiting
Brasília
Hospital Vera Cruz
Recruiting
Campinas
Santa Casa de Marília
Recruiting
Cascata
Sociedade Hospitalar Angelina Caron
Recruiting
Centro
Instituto de Ensino e Pesquisa do Hospital da Bahia
Recruiting
Pituba
Hospital Maternidade e Pronto Socorro Santa Lúcia
Recruiting
Poços De Caldas
Instituto de Cardiologia do RS
Recruiting
Porto Alegre
Hospital Agamenon Magalhães
Recruiting
Recife
Pronto Socorro Cardiológico de Pernambuco Prof. Luiz Tavares- PROCAPE
Recruiting
Recife
Hospital Cárdio Pulmonar
Recruiting
Salvador
Hospital Universitário Professor Edgard Santos
Recruiting
Salvador
Hospital de Base de Rio Preto
Recruiting
São José Do Rio Preto
Hospital de Base de Rio Preto
Recruiting
São José Do Rio Preto
Hospital São Paulo
Recruiting
São Paulo
Hospital de Clínicas da UFTM
Recruiting
Uberaba
Hospital das Clinicas da UFU
Recruiting
Uberlândia
Canada
Foothills Medical Centre
Recruiting
Calgary
Grey Nuns Community Hospital
Recruiting
Edmonton
Royal Alexandra Hospital
Recruiting
Edmonton
University of Alberta Hospital
Recruiting
Edmonton
Hôpital Charles Lemoyne
Recruiting
Greenfield Park
QE II Health Sciences Center
Recruiting
Halifax
Hamilton Health Sciences
Recruiting
Hamilton
Hamilton St. Joseph's Health
Recruiting
Hamilton
St. Joseph's Health Centre
Recruiting
Hamilton
Hotel-Dieu de Levis
Recruiting
Levis
University Hospital - LHSC
Recruiting
London
Victoria Hospital - LHSC
Recruiting
London
Jewish General Hospital
Recruiting
Montreal
Centre Hosp. Universitaire de Montréal
Recruiting
Montréal
Montreal General Hospital
Recruiting
Montréal
Royal Victoria Hospital
Recruiting
Montréal
Royal Columbian Hospital
Recruiting
New Westminster
Quebec Heart and Lung Institute
Recruiting
Québec City
Regina General Hospital
Recruiting
Regina
Centre Hospitalier Universitaire de Sherbrooke
Recruiting
Sherbrooke
Surrey Memorial Hospital
Recruiting
Surrey
St. Michael's Hospital
Recruiting
Toronto
Sunnybrook Health Sciences Centre
Recruiting
Toronto
General Hospital Trois-Rivièrs
Recruiting
Trois-rivières
Vancouver General Hospital
Recruiting
Vancouver
Victoria Heart Institute
Recruiting
Victoria
St. Boniface General Hospital
Recruiting
Winnipeg
France
CHRU Tours -Hôpital Trousseau
Recruiting
Chambray-lès-tours
CH Chartres - Chartres
Recruiting
Chartres
Centre Hospitalier Sud Francilien
Recruiting
Corbeil-essonnes
CHU le Bocage - Dijon
Recruiting
Dijon
La Tronche Hôpital Michallon
Recruiting
La Tronche
Centre Hospitalier Universitaire de Lille
Recruiting
Lille
CHU Arnaud de Villeneuve - Montpellier
Recruiting
Montpellier
CHU Nancy
Recruiting
Nancy
Hôpital Pasteur
Recruiting
Nice
Hôpital Universitaire Carémeau (CHU Carémeau)
Recruiting
Nîmes
Hôpital BICHAT- APHP
Recruiting
Paris
Hôpital Européen Georges-Pompidou
Recruiting
Paris
Hôpital La Pitié Salpétrière
Recruiting
Paris
Hôpital Lariboisière
Recruiting
Paris
Hôpital Haut Lévêque
Recruiting
Pessac
CHU Poitiers - Poitiers
Recruiting
Poitiers
Hôpital Charles Nicolle- Rouen
Recruiting
Rouen
Hôpital Rangueil
Recruiting
Toulouse
New Zealand
Auckland City Hospital
Recruiting
Auckland
Christchurch Hospital
Recruiting
Christchurch
Gisborne Hospital
Recruiting
Gisborne
Nelson Hospital
Recruiting
Nelson
Taranaki Hospital
Recruiting
New Plymouth
Whangarei Hospital
Recruiting
Whangarei
Contact Information
Primary
Jeffrey L Carson, MD
Jeffrey.Carson@Rutgers.edu
732-235-7122
Backup
Helaine Noveck, MPH
Helaine.Noveck@Rutgers.edu
732-235-6581
Time Frame
Start Date: April 25, 2017
Estimated Completion Date: October 2023
Participants
Target number of participants: 3500
Treatments
Active Comparator: Liberal Transfusion Strategy
Red blood cell transfusion - One unit of packed red cells is transfused following randomization followed by enough red blood cell units to raise the hemoglobin concentration above 10 g/dL any time the hemoglobin concentration is detected to be below 10g/dL during the hospitalization for up to 30 days.
Active Comparator: Restrictive Transfusion Strategy
Permitted to receive a red blood cell transfusion if the blood count is below 8 g/dL and the physician believes it is in the patient's best interest. A transfusion will be strongly recommended if the blood count drops to less than 7 g/dL. If the patient has symptoms of angina (e.g., chest discomfort described as pressure or heaviness) that do not go away with medication, a blood transfusion will be ordered regardless of the blood count.
Authors
Lynn Uhl, Rajesh Hiralal, Minakshi Madan, Tamar Tamar, Kodangudi Ramanthan, Nicolas Michaud, Tandon Vikas, Paul Greunwald, Josehph Rossi, Benoît Daneault, Michael Gaglia, Christopher Stowell, Raj C Shah, Ramin Ebrahimi, Craig M Hudak, Lydia Howard, Brian Potter, J. Dawn Abbott, Mark Menegus, Kevin R Bainey, Hal Wasserman, Gregory W Barsness, Frances Wood, Gregary Marhefka, Jonathan Doroshow, Paolo Mascari, Brendan Duffy, Adam C Salisbury, Christopher Fordyce, Barry Uretsky, Mark Schmidhofer, Robert C Hendel, Luis Gruberg, Wilson Ginete, Sorin Brener, Srikanth Vallurupalli, Joseph Delehanty, Ganesh Raveendran, Michael Goldfarb, Payam Dehghani, Carl Reimers, Perry Weinstock, Robert Roswell, Thao Huynh, Xuming Dai, William Lawson, Jason Scott, Mark Sheldon, Howard Cooper, Omar Siddiqi, Michael Carson, Jay Traverse, Paul Mullen, David Landers, Meechai Tessalee, Norma Keller, Gregory Schnell, Michael Gitter, Herbert Aronow, Gregory Maniatis, Farhad Abtahian, Mansoor Qureshi, Andrew DeFilippis, Warren K Laskey, Shahab Ghafghazi, Michael Kontos, Arthur Bracey, Maria Mori Brooks, Rajiv Jauhar, Jeffrey L Carson, William H Matthai, Richard Bach, Tom Ford, Richard Haichin, Terry McPherson, Gerald Vanzetto, Francois Roubille, Jean Guillaume Dillinger, Gilles Lemesle, Gregory Ducrocq, Batric Popovic, Yves Cottin, Yann Rosamel, Thibault Lhermusier, Benoit Lattuca, Pierre Coste, Christophe Thuaire, Emile Ferrari, Denis Angoulvant, Etienne Puymirat, Claire Bouleti, Johanne Silvain, Fernando de Martino, Marianna Andrade, Jocelyne Benatar, Derek Chew, Jamil Abdalla Abdalla Saad, Michael P Thomas, John Neary, João Batista de Moura Xavier de Moraes Júnior, John Elliott, David Laflamme, Alberto Gomes Taques Fonseca, Samraj Nandra, Nicholas Fisher, Dario Sobral Filho, Ian Ternouth, Jean-Pierre Dery, John Ducas, François-Martin Carrier, Alexandre Schaan de Quadros, Gerard Devlin, Luiz Eduardo Fonteles Ritt, Sia Ying Tung Sia, Razi Khan, Roque Aras, Vikas Tandon, Akshay Bagai, Graham S Hillis, Pedro Beraldo De Andrade, Frederico Toledo Campo Dall'Orto, David Brieger, Elmiro Santos Resende, Manohara Senaratne, Eric Durand, Ata Ur Rehman Quraishi, Sunil Rao, Neil Brass, Lilia Nigro Maia, Kunal Minhas, Friederike Keating, Estevao Lanna Figueiredo, Simon Robinson, Adriano Caixeta, Joshua Schulman-Marcus, Dalton Precoma
Sponsors
Leads: Rutgers, The State University of New Jersey
Collaborators: National Heart, Lung, and Blood Institute (NHLBI), University of Pittsburgh

This content was sourced from clinicaltrials.gov