TRICS-III: Transfusion Requirements in Cardiac Surgery III

Sponsor

Unity Health Toronto (Other)

Overall Status

Completed

CT.gov ID

NCT02042898

Collaborator

(none)

5,028

Enrollment

Locations

Arms

44.4

Actual Duration (Months)

67.9

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

TRICS-III is an international, multi-centre, open-label randomized controlled trial of two commonly used transfusion strategies in high risk patients having cardiac surgery using a non-inferiority trial design.

Condition or Disease	Intervention/Treatment	Phase
Disorder; Heart, Functional, Postoperative, Cardiac Surgery	Other: Restrictive Transfusion Strategy Other: Liberal transfusion strategy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

5028 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

An International, Multi-centre, Randomized Controlled Trial to Assess Transfusion Thresholds in Patients Undergoing Cardiac Surgery

Actual Study Start Date :

Jan 20, 2014

Actual Primary Completion Date :

Apr 28, 2017

Actual Study Completion Date :

Oct 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Restrictive transfusion strategy Restrictive transfusion strategy: patients will receive a red cell transfusion if their hemoglobin is <75 g/L (<7.5 g/dL;<4.7mmol/L) intraoperatively and/or postoperatively	Other: Restrictive Transfusion Strategy
Active Comparator: Liberal transfusion strategy Liberal transfusion strategy: patients will receive a red cell transfusion if their hemoglobin concentration is <95 g/L (<9.5 g/dL<5.9mmol/L) intraoperatively, or postoperatively in the intensive care unit; and/or <85 g/L (< 8.5 g/dL;<5.3mmol/L) on the ward.	Other: Liberal transfusion strategy

Arm

Intervention/Treatment

Active Comparator: Restrictive transfusion strategy

Restrictive transfusion strategy: patients will receive a red cell transfusion if their hemoglobin is <75 g/L (<7.5 g/dL;<4.7mmol/L) intraoperatively and/or postoperatively

Other: Restrictive Transfusion Strategy

Active Comparator: Liberal transfusion strategy

Liberal transfusion strategy: patients will receive a red cell transfusion if their hemoglobin concentration is <95 g/L (<9.5 g/dL<5.9mmol/L) intraoperatively, or postoperatively in the intensive care unit; and/or <85 g/L (< 8.5 g/dL;<5.3mmol/L) on the ward.

Other: Liberal transfusion strategy

Outcome Measures

Primary Outcome Measures

Composite score of any one of the following: (1) all-cause mortality; (2) myocardial infarction; (3) new renal failure requiring dialysis; or (4) new focal neurological deficit [Up to hospital discharge or postoperative day 28 (whichever occurs first)]
Composite score of any one of the following events occurring during the index hospitalization (from the start of surgery until hospital discharge or postoperative day 28, whichever comes first): (1) all-cause mortality; (2) myocardial infarction; (3) new renal failure requiring dialysis; or (4) new focal neurological deficit

Secondary Outcome Measures

Incidence of in-hospital all-cause mortality [Up to hospital discharge or postoperative day 28 (whichever occurs first)]
Incidence of in-hospital myocardial infarction [Up to hospital discharge or postoperative day 28 (whichever occurs first)]
Incidence of in-hospital new renal failure requiring dialysis [Up to hospital discharge or postoperative day 28 (whichever occurs first)]
Incidence of in-hospital new focal neurological deficit [Up to hospital discharge or postoperative day 28 (whichever occurs first)]
Length of stay in the ICU and hospital [Up to hospital discharge or postoperative day 28 (whichever occurs first)]
Prolonged low output state defined as the need for two or more inotropes for 24 hours or more, intra-aortic balloon pump postoperatively or ventricular assist device [Up to hospital discharge or postoperative day 28 (whichever occurs first)]
Duration of mechanical ventilation [Up to hospital discharge or postoperative day 28 (whichever occurs first)]
Incidence of infection [Up to hospital discharge or postoperative day 28 (whichever occurs first)]
Acute kidney injury (defined by Kidney Disease Improving Global Outcomes criteria) [Up to hospital discharge or postoperative day 28 (whichever occurs first)]
Incidence of gut infarction [Up to hospital discharge or postoperative day 28 (whichever occurs first)]
The proportion of patients transfused and the number of blood products and hemostatic products utilized (e.g. red cells, plasma, platelets, cryoprecipitate, factor VII) (index hospitalization) [Up to hospital discharge or postoperative day 28 (whichever occurs first)]
Death [6 months]
New onset dialysis (since incident surgery) status [6 months]
Stroke [6 months]
Coronary revascularization [6 months]
Myocardial infarction [6 months]
Health Care Utilization [6 months]
Renal function, based on changes in postoperative serum creatinine [Up to hospital discharge or postoperative day 28 (whichever occurs first)]
Incidence of Seizures [Up to hospital discharge or postoperative day 28 (whichever occurs first)]
Incidence of Encephalopathy [Up to hospital discharge or postoperative day 28 (whichever occurs first)]
Incidence of Delirium [Up to hospital discharge or postoperative day 28 (whichever occurs first)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 18 or older
Planned cardiac surgery using cardiopulmonary bypass
Informed consent obtained
Preoperative European System for Cardiac Operative Risk Evaluation (EuroSCORE I) of 6 or more

Exclusion Criteria:

Patients who are unable to receive or who refuse blood products
Patients who are involved in a preoperative autologous pre-donation program
Patients who are having a heart transplant or having surgery solely for an insertion of a ventricular assist device
Pregnancy or lactation (a negative pregnancy test must be obtained prior to randomization for women of childbearing potential.)
Patients who are unable to receive or who refuse blood products

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	San Francisco VA Medical Center	San Francisco	California	United States	94121
2	Yale-New Haven Hospital	New Haven	Connecticut	United States	06510-3202
3	Maine Medical Center	Portland	Maine	United States
4	Montefiore Medical Center	Bronx	New York	United States	10467
5	Durham Veterans Affairs Medical Center	Durham	North Carolina	United States	27705
6	University of Texas Southwestern Medical Center	Dallas	Texas	United States	75235
7	Baylor College of Medicine	Houston	Texas	United States	77030
8	Michael E. DeBakey Veterans Affairs Medical Center	Houston	Texas	United States	77030
9	Royal Prince Alfred Hospital	Camperdown	New South Wales	Australia	2050
10	Royal North Shore Hospital	Sydney	New South Wales	Australia	2065
11	Westmead Hospital	Westmead	New South Wales	Australia	2145
12	Royal Adelaide Hospital	Adelaide	South Australia	Australia	5000
13	Flinders Medical Centre	Bedford Park	South Australia	Australia	5042
14	Monash Medical Centre	Clayton	Victoria	Australia	3168
15	St Vincent's Hospital, Melbourne	Fitzroy	Victoria	Australia	3065
16	Austin Hospital	Heidelberg	Victoria	Australia	3084
17	Cabrini Health	Malvern	Victoria	Australia	3144
18	Alfred Hospital	Melbourne	Victoria	Australia	3004
19	Barwon Health (University Hospital Geelong)	Melbourne	Victoria	Australia	3220
20	Royal Melbourne Hospital	Parkville	Victoria	Australia	3050
21	Hospital Unimed Rio (National Institute of Cardiology)	Rio de Janeiro		Brazil
22	Foothills Medical Centre	Calgary	Alberta	Canada	T2N 2T9
23	University of Alberta	Edmonton	Alberta	Canada	T6G 2R3
24	Kelowna General Hospital	Kelowna	British Columbia	Canada	V1Y 1T2
25	Vancouver General Hospital	Vancouver	British Columbia	Canada	V5Z 1L7
26	St Boniface Hospital	Winnipeg	Manitoba	Canada	R2H 2A6
27	Saint John Regional Hospital	Saint John	New Brunswick	Canada	E2L 4L4
28	Health Sciences Centre (Memorial University)	St John's	Newfoundland and Labrador	Canada	A1B 3X9
29	QEII Health Science Centre	Halifax	Nova Scotia	Canada	B3H 2Y9
30	Hamilton General Hospital	Hamilton	Ontario	Canada	L8L 2X2
31	Kingston General Hospital	Kingston	Ontario	Canada	K7L 2V7
32	London Health Sciences Center	London	Ontario	Canada	N6G 2V4
33	Southlake Regional Health Centre	Newmarket	Ontario	Canada	L3Y 2P9
34	University of Ottawa Heart Institute	Ottawa	Ontario	Canada	K1Y 4W7
35	Sunnybrook Health Sciences Centre	Toronto	Ontario	Canada	M4N 3M5
36	St Michael's Hospital	Toronto	Ontario	Canada	M5B1W8
37	University Health Network Toronto General Hospital	Toronto	Ontario	Canada	M5G 2C4
38	Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)	Chemin Sainte-Foy	Quebec	Canada	G1V 4G5
39	SMBD Jewish General Hospital	Montreal	Quebec	Canada	H3T 1E2
40	Hôpital du Sacré-Cœur de Montréal	Montreal	Quebec	Canada	H4J 1C5
41	Centre hospitalier de l'Université de Montréal	Montreal	Quebec	Canada
42	Montreal Heart Institute	Montréal	Quebec	Canada	H1T 1C8
43	Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke	Quebec	Canada	J1G 2E8
44	Shanghai Yodak Cardio-Thoracic Hospital	Shanghai		China	200235
45	Renji Hospital	Shanghai		China
46	Instituto del Corazón de Bucaramanga	Bucaramanga	Santander	Colombia
47	Clinica de Marly	Bogota		Colombia
48	Fundacion Cardioinfantil Instituto de Cardiologia	Bogota		Colombia
49	Fundación Clínica Shaio	Bogota		Colombia
50	Hospital De San Jose	Bogota		Colombia
51	Rigshospitalet - Copenhagen University Hospital	Copenhagen		Denmark	2100
52	Tanta University Hospital	Tanta		Egypt
53	Charité - Universitätsmedizin Berlin	Berlin		Germany	10117
54	University Hospital Giessen	Giessen		Germany
55	University of Thessaly	Volos		Greece
56	Narayana Health	Bangalore	Karnataka	India
57	SAL Hospital	Gujarat		India	380054
58	Sheba Medical Center	Ramat Gan		Israel	5262100
59	Tel Aviv Sourasky Medical Centre	Tel Aviv		Israel	64239
60	Institut Jantung Negara	Kuala Lampur		Malaysia	50400
61	Auckland City Hospital	Auckland		New Zealand	1023
62	Christchurch Hospital	Christchurch		New Zealand	4710
63	Dunedin Hospital	Dunedin		New Zealand	9016
64	Waikato Hospital	Hamilton		New Zealand	3204
65	Wellington Hospital	Wellington		New Zealand	6021
66	Emergency Institute for Cardiovascular Diseases	Târgu-Mureș		Romania
67	National Heart Centre Singapore	Singapore		Singapore
68	University of KwaZulu-Natal	Durban	KwaZulu-Natal	South Africa	4041
69	Hospital de la Santa Creu i Sant Pau	Barcelona		Spain
70	Hospital Ramón y Cajal	Madrid		Spain
71	Consorcio Hospital General Universitario de Valencia	Valencia		Spain	46014
72	Instituto de Investigación Sanitaria Hospital Univ. & Politc. La Fe de Valencia	Valencia		Spain	46026
73	University Hospital Basel	Basel		Switzerland	4056
74	University Hospital Bern (Inselspital)	Bern		Switzerland

Sponsors and Collaborators

Unity Health Toronto

Investigators

Principal Investigator: David Mazer, MD, Unity Health Toronto
Principal Investigator: Nadine Shehata, MD, MOUNT SINAI HOSPITAL
Principal Investigator: Richard Whitlock, MD, McMaster University
Principal Investigator: Dean Fergusson, MD, Ottawa Hospital Research Institute
Principal Investigator: Kevin Thorpe, MSc, University of Toronto

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Unity Health Toronto

ClinicalTrials.gov Identifier:

NCT02042898

Other Study ID Numbers:

TRICSIII
301852

First Posted:

Jan 23, 2014

Last Update Posted:

Aug 15, 2018

Last Verified:

Aug 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Keywords provided by Unity Health Toronto

Cardiac Surgery

Transfusion

Study Results

No Results Posted as of Aug 15, 2018