MINT: Myocardial Ischemia and Transfusion

Sponsor

Rutgers, The State University of New Jersey (Other)

Overall Status

Recruiting

CT.gov ID

NCT02981407

Collaborator

University of Pittsburgh (Other), National Heart, Lung, and Blood Institute (NHLBI) (NIH)

3,500

Enrollment

132

Locations

Arms

77.2

Anticipated Duration (Months)

26.5

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction Anemia	Biological: Red Blood Cell Transfusion	Phase 3

Detailed Description

In most clinical settings, evidence suggests it is safe to wait to give a blood transfusion. However, for those who have suffered a heart attack, there is a lack of high quality evidence to guide transfusions. This 3500 subject multi-center randomized trial will fill that void.

Hospital inpatients diagnosed with myocardial infarction who have blood counts less than 10 g/dL are randomized to receive either a liberal or a restrictive transfusion strategy.

Patients randomized to the liberal transfusion strategy will receive a red blood cell transfusion anytime there is a blood count of less than 10 g/dL.

Patients randomized to the restrictive transfusion strategy are permitted to receive a blood 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 is ordered regardless of the blood count.

The transfusions strategies will be maintained until hospital discharge for a maximum of 30 days.

Patients will be followed for 30 days for clinically relevant outcomes. Vital status will be confirmed at 180 days.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

3500 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Myocardial Ischemia and Transfusion

Actual Study Start Date :

Apr 25, 2017

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.	Biological: Red Blood Cell Transfusion Transfusion of packed red blood cell units
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.	Biological: Red Blood Cell Transfusion Transfusion of packed red blood cell units

Arm

Intervention/Treatment

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.

Biological: Red Blood Cell Transfusion

Transfusion of packed red blood cell units

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.

Biological: Red Blood Cell Transfusion

Transfusion of packed red blood cell units

Outcome Measures

Primary Outcome Measures

Composite outcome of all-cause mortality or nonfatal myocardial reinfarction [Within 30 days of randomization]

Secondary Outcome Measures

All-cause mortality [Within 30 days of randomization]
Myocardial reinfarction [Within 30 days of randomization]
Composite of all-cause mortality, nonfatal myocardial reinfarction, ischemia driven unscheduled coronary revascularization, or readmission to the hospital for ischemic cardiac diagnosis [Within 30 days of randomization]

Other Outcome Measures

Composite of all-cause mortality,nonfatal myocardial reinfarction, or unstable angina [Within 30 days of randomization]
Ischemia driven unscheduled coronary revascularization [Within 30 days of randomization]
Unscheduled readmission to hospital for ischemic cardiac diagnosis [Within 30 days of randomization]
Congestive heart failure [Within 30 days of randomization]
Unscheduled readmission to hospital for any reason [Within 30 days of randomization]
Stroke [Within 30 days of randomization]
Pulmonary embolism or deep venous thrombosis [Within 30 days of randomization]
Bleed [Within 30 days of randomization]
Pneumonia [Within 30 days of randomization]
Blood stream infection [Within 30 days of randomization]
Urinary tract infection [Within 30 days of randomization]
Length of hospital stay post randomization [Within 30 days of randomization]
Number of days post randomization in intensive care unit [Within 30 days of randomization]
Patient reported quality of life [Within 30 days of randomization]
EuroQol questionnaire
All-cause mortality [Within 6 months of randomization]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Uncontrolled acute bleeding at the time of randomization defined as the need for uncrossed or non-type specific blood
Decline blood transfusion
Scheduled for cardiac surgery during the current admission
Receiving only palliative treatment
Known that follow-up will not be possible at 30 days
Previously participated in MINT
Currently enrolled in a competing study that interferes with the intervention or follow-up of MINT or enrolled in a competing study that has not been approved by the local Institutional Review Board
Patient physician does not believe the patient is an appropriate candidate for the trial

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Central Arkansas Veterans Healthcare System	Little Rock	Arkansas	United States	72205
2	University of Arkansas Medical Sciences (UAMS) Hospital	Little Rock	Arkansas	United States	72205
3	VAGLAHS	Los Angeles	California	United States	90073
4	Danbury Hospital	Danbury	Connecticut	United States	06810
5	Rush University Medical Center	Chicago	Illinois	United States	60612
6	University of Chicago Medical Center	Chicago	Illinois	United States	60637
7	Alexian Brothers Medical Center	Elk Grove Village	Illinois	United States	60007
8	AMITA Health	Hinsdale	Illinois	United States	60521
9	Saint Luke's Mid America Heart	Kansas City	Kansas	United States	64111
10	University of Louisville	Louisville	Kentucky	United States	40202
11	Tulane University School of Medicine	New Orleans	Louisiana	United States	70112
12	Massachusetts General Hospital	Boston	Massachusetts	United States	01930
13	Boston Medical Center	Boston	Massachusetts	United States	02118
14	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	15261
15	Lahey Hospital	Burlington	Massachusetts	United States	01805
16	University of Michigan	Ann Arbor	Michigan	United States	48109
17	St. Joseph Mercy Health System	Ypsilanti	Michigan	United States	48197
18	Essentia Health	Duluth	Minnesota	United States	55805
19	University of Minnesota Medical Center Fairview	Minneapolis	Minnesota	United States	55105
20	Minneapolis Heart Institute (Foundation)	Minneapolis	Minnesota	United States	55407-1130
21	Mayo Clinic	Rochester	Minnesota	United States	55905
22	Memorial Hospital at Gulfport	Gulfport	Mississippi	United States	39502
23	Washington University	Saint Louis	Missouri	United States	63110
24	Copper University Hospital	Camden	New Jersey	United States	08103
25	Hackensacjk University Medical Center	Hackensack	New Jersey	United States	07601
26	Jersey Shore University Medical	Neptune	New Jersey	United States	08759
27	Robert Wood Johnson University Hospital	New Brunswick	New Jersey	United States	08903
28	University of New Mexico	Albuquerque	New Mexico	United States	87131
29	Albany Medical College	Albany	New York	United States	12208
30	Southside Hospital	Bay Shore	New York	United States	11706
31	Montefiore Medical Center	Bronx	New York	United States	10467
32	NYP Brooklyn Methodist	Brooklyn	New York	United States	11215
33	New York Presbyterian/Queens	Flushing	New York	United States	11355
34	Westchester Medical Center	Hawthorne	New York	United States	10532
35	North Shore University Hospital	Manhasset	New York	United States	11030
36	Northern Westchester Hospital	Mount Kisco	New York	United States	10549
37	NYU Langone Medical Center, Bellevue Hospital	New York	New York	United States	10016
38	Lenox Hilll Hospital	New York	New York	United States	10075
39	Rochester General Hospital	Rochester	New York	United States	14450
40	University of Rochester	Rochester	New York	United States	14642
41	Northwell Staten Island Hopsital	Staten Island	New York	United States	10305
42	Stony Brook Medicine	Stony Brook	New York	United States	11794-8167
43	The University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	United States	27599-7097
44	Durham Va	Durham	North Carolina	United States	27705
45	WakeMed Health and Hospital	Raleigh	North Carolina	United States	27610
46	Aultman Hospital	Canton	Ohio	United States	44710
47	University of Toledo Medical Center	Toledo	Ohio	United States	43614
48	Lancaster General Hospital	Lancaster	Pennsylvania	United States	17602
49	PENN Presbyterian Medical Cente	Philadelphia	Pennsylvania	United States	19104
50	Thomas Jefferson University	Philadelphia	Pennsylvania	United States	19107
51	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15261
52	Lankenau Medical Center	Wynnewood	Pennsylvania	United States	19096
53	Rhode Island Hospital	Providence	Rhode Island	United States	02903
54	The Miriam Hospital	Providence	Rhode Island	United States	02906
55	Greenville Health System	Greenville	South Carolina	United States	29605
56	The Memphis VAMC	Memphis	Tennessee	United States	38104
57	Baylor St Luke's Medical Center	Houston	Texas	United States	77030
58	University of Vermont Medical Center	Burlington	Vermont	United States	05401
59	Virginia Commonwealth University	Richmond	Virginia	United States	23298
60	Medical College of Wisconsin - Froedtert Hospital	Milwaukee	Wisconsin	United States	53226
61	Flinders Medical Centre	Bedford Park		Australia
62	Concord Repatriation General Hospital	Concord		Australia
63	Gosford Hospital	Gosford		Australia
64	Royal Perth Hospital	Perth		Australia
65	Instituto de Ensino e Pesquisa do Hospital da Bahia	Pituba	Salvador	Brazil	41810
66	Hospital de Base de Rio Preto	São José do Rio Preto	São Paulo	Brazil	15080-310
67	Hospital Felício Rocho	Belo Horizonte		Brazil
68	Instituto de Ensino e Pesquisa do Hospital do Coração do Brasil	Brasília		Brazil
69	Hospital Vera Cruz	Campinas		Brazil
70	Santa Casa de Marília	Cascata		Brazil	17515-900
71	Sociedade Hospitalar Angelina Caron	Centro		Brazil	83430-000
72	Instituto de Cardiologia do RS	Porto Alegre		Brazil
73	Hospital Maternidade e Pronto Socorro Santa Lúcia	Poços De Caldas		Brazil
74	Hospital Agamenon Magalhães	Recife		Brazil
75	Pronto Socorro Cardiológico de Pernambuco Prof. Luiz Tavares- PROCAPE	Recife		Brazil
76	Hospital Cárdio Pulmonar	Salvador		Brazil
77	Hospital Universitário Professor Edgard Santos	Salvador		Brazil
78	Hospital de Base de Rio Preto	São José Do Rio Preto		Brazil
79	Hospital São Paulo	São Paulo		Brazil	04024-002
80	Hospital de Clínicas da UFTM	Uberaba		Brazil
81	Hospital das Clinicas da UFU	Uberlândia		Brazil
82	Foothills Medical Centre	Calgary	Alberta	Canada
83	Grey Nuns Community Hospital	Edmonton	Alberta	Canada
84	Royal Alexandra Hospital	Edmonton	Alberta	Canada
85	University of Alberta Hospital	Edmonton	Alberta	Canada
86	Royal Columbian Hospital	New Westminster	British Columbia	Canada
87	Surrey Memorial Hospital	Surrey	British Columbia	Canada
88	Vancouver General Hospital	Vancouver	British Columbia	Canada
89	St. Boniface General Hospital	Winnipeg	Manitoba	Canada
90	QE II Health Sciences Center	Halifax	Nova Scotia	Canada
91	Hamilton Health Sciences	Hamilton	Ontario	Canada
92	Hamilton St. Joseph's Health	Hamilton	Ontario	Canada
93	St. Joseph's Health Centre	Hamilton	Ontario	Canada
94	University Hospital - LHSC	London	Ontario	Canada
95	Victoria Hospital - LHSC	London	Ontario	Canada
96	St. Michael's Hospital	Toronto	Ontario	Canada
97	Sunnybrook Health Sciences Centre	Toronto	Ontario	Canada
98	Victoria Heart Institute	Victoria	Ontario	Canada
99	Hôpital Charles Lemoyne	Greenfield Park	Quebec	Canada
100	Hotel-Dieu de Levis	Levis	Quebec	Canada
101	Jewish General Hospital	Montreal	Quebec	Canada
102	Centre Hosp. Universitaire de Montréal	Montréal	Quebec	Canada
103	Montreal General Hospital	Montréal	Quebec	Canada
104	Royal Victoria Hospital	Montréal	Quebec	Canada
105	Quebec Heart and Lung Institute	Québec City	Quebec	Canada
106	Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke	Quebec	Canada
107	General Hospital Trois-Rivièrs	Trois-Rivières	Quebec	Canada
108	Regina General Hospital	Regina	Saskatchewan	Canada
109	CHRU Tours -Hôpital Trousseau	Chambray-lès-Tours		France
110	CH Chartres - Chartres	Chartres		France
111	Centre Hospitalier Sud Francilien	Corbeil-Essonnes		France
112	CHU le Bocage - Dijon	Dijon		France	21079
113	La Tronche Hôpital Michallon	La Tronche		France
114	Centre Hospitalier Universitaire de Lille	Lille		France	59000
115	CHU Arnaud de Villeneuve - Montpellier	Montpellier		France
116	CHU Nancy	Nancy		France
117	Hôpital Pasteur	Nice		France	06000
118	Hôpital Universitaire Carémeau (CHU Carémeau)	Nîmes		France	30029
119	Hôpital La Pitié Salpétrière	Paris		France	75013
120	Hôpital Européen Georges-Pompidou	Paris		France	75015
121	Hôpital BICHAT- APHP	Paris		France	75018
122	Hôpital Lariboisière	Paris		France
123	Hôpital Haut Lévêque	Pessac		France	33604
124	CHU Poitiers - Poitiers	Poitiers		France
125	Hôpital Charles Nicolle- Rouen	Rouen		France
126	Hôpital Rangueil	Toulouse		France	31400
127	Auckland City Hospital	Auckland		New Zealand
128	Christchurch Hospital	Christchurch		New Zealand
129	Gisborne Hospital	Gisborne		New Zealand
130	Nelson Hospital	Nelson		New Zealand
131	Taranaki Hospital	New Plymouth		New Zealand
132	Whangarei Hospital	Whangarei		New Zealand

Sponsors and Collaborators

Rutgers, The State University of New Jersey
University of Pittsburgh
National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator: Jeffrey L Carson, MD, Rutgers Robert Wood Johnson Medical School
Principal Investigator: Maria Mori Brooks, PhD, University of Pittsburgh