Heart DiseasesTACSNCT02200419
POC - Transfusion Algorithm Cardiac Study
A study testing POC-based transfusion algorithm in people with Heart Diseases, run by University Health Network, Toronto at 12 sites in Canada.
Trial summary
This multi-centre study will provide sound, generalizable data on the effectiveness of a POC-based algorithm to determine to what extent this guideline can reduce blood product transfusions. Investigators will study outcomes in 7000 patients undergoing heart surgery at 10 participating hospitals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Diseases
- What is being tested?
- POC-based transfusion algorithm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,402 participants
- Where
- 12 sitesCanada
- Study dates
- Oct 2014to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Hospital Inclusion:
- Participating hospitals must not currently be using a POC-based blood conservation algorithm; must have an in-hospital RBC transfusion rate of > 35% and platelet or plasma transfusion rates of > 20%; must conduct > 600 cardiac surgeries employing CPB per year; and must have commitments from departments of Anesthesia, Cardiac Surgery, and Laboratory Medicine to support the study and to abide by the algorithm
- Blood transfusion algorithm instituted as standard-of-care at participating hospitals
- All adult (≥ 18 years) patients undergoing cardiac surgery with cardiopulmonary bypass (CPB) will be included in the analysis.
Exclusion Criteria: Hospitals not meeting inclusion.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Canada12 sites
Dr. Charles McAdams
Calgary, Alberta, T2N 2T9
Blaine Achen
Edmonton, Alberta
Dr. E. Medicis
Fleurimont, Quebec, J1H 5N4
Dr. Summer Syed
Hamilton, Ontario, L8N 3Z5
Dr. Christopher Harle
London, Ontario, N6A 5A5
Dr. Daniel Kim
Newmarket, Ontario, L3Y 2P9
Dr. D. Tran
Ottawa, Ontario, K1Y 4W7
Dr. J. Bussieres
Sainte-Foy, Quebec, G1V 4G5
Dr. F. Moussa
Toronto, Ontario, M4N 3M5
Dr. Terry Waters
Vancouver, British Columbia, V5Z 1M9
Dr. Sukhpal Brar
Vancouver, British Columbia
Dr. H. Grocott
Winnipeg, Manitoba, R2H 2A6
About this study
Official title: Blood Conservation in Cardiac Surgery Using a Novel Transfusion Algorithm Based on Point-of-care Testing-A Stepped-wedge Cluster Randomized Controlled Trial
This multi-centre study will provide sound, generalizable data on the effectiveness of a POC-based algorithm to determine to what extent this guideline can reduce blood product transfusions. Investigators will study outcomes in 7000 patients undergoing heart surgery at 10 participating hospitals. The proposed trial addresses several important research and clinical issues and has the potential to markedly improve the transfusion management and surgical care in general of cardiac surgery patients.
The intervention will be a novel POC-based algorithm that has been shown in a pilot study by us to be associated with a substantial reduction in blood product transfusions. The algorithm will employ viscoelastic and aggregometric POC-tests and an objective measure of blood loss. The primary outcome will be avoidance of red blood cell transfusion during hospitalization. The study has a 90% power to detect a 12% increase in avoidance rate. Secondary outcomes will include avoidance of red blood cell use and other blood products (plasma, platelets, and cryoprecipitate), units of blood products transfused, and adverse clinical outcomes related to transfusion (acute kidney injury, infections, and death). Data will also be collected for future health-economics analyses.
Read more
Largely due to the limitations of existing evidence, however, such algorithms are rarely used in clinical practice. The proposed trial will provide sound, generalizable data on the effectiveness of a POC-based algorithm to guide their future use. An integrated blood management algorithm that employs POC coagulation tests will reduce blood product transfusions in cardiac surgery, thereby improving clinical outcomes.
Does an integrated blood transfusion algorithm that employs POC coagulation tests applied across a network of hospitals reduce blood transfusions and associated adverse outcomes in cardiac surgery?
Read the detailed description
Despite major advances in cardiac surgery, coagulopathy continues to carry a heavy burden in cases that require the use of cardiopulmonary bypass (CPB), occurring frequently and resulting in excessive blood loss, blood product transfusions, and adverse clinical outcomes. Current management of coagulopathy is hampered by the inability of conventional laboratory tests to delineate its etiology in a timely manner, thereby precluding timely and targeted transfusion therapy. With the advent of point-of-care (POC) coagulation tests that can rapidly identify the etiology of coagulopathy, it may now be possible to reduce the burden of coagulopathy and thereby reduce transfusions and adverse outcomes. Several single-centre studies (including one by the investigator group) have found that the use of POC-based algorithms in cardiac surgery can markedly reduce blood product transfusions and by that means reduce morbidities and mortality.
- Conditions
- Heart Diseases
- Being tested
- POC-based transfusion algorithm
- Keywords
- Rotem, Point of care coagulation tests, Cardiac surgery, Vascular surgery, Cardiopulmonary bypass, Blood products, Transfusion, Viscoelastic coagulation
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POC-based transfusion algorithmOther
A transfusion algorithm based on point-of-care coagulation testing.
| Study group | Role | What they receive |
|---|---|---|
| Transfusion Algorithm | Other | Hospitals will be randomized to the intervention arm of the study in a stratified manner. Receives: Other: POC-based transfusion algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Point Of Care (POC) Transfusion Algorithm Cardiac Study
The primary outcome measure will be the proportion of patients who receive any allogeneic red blood cell (RBC) transfusion from admission before surgery to end of follow-up.
Measured: 2.5 years
Secondary outcomes (5)
Transfusion
Allogeneic blood products (platelets, plasma, cryoprecipitate) or coagulation factors (e.g., fibrinogen concentrate, factor VIIa), or undergo re-exploration; units of blood products transfused, nadir hemoglobin concentration (to identify changes in transfusion practice that may be unrelated to treatment of coagulopathy)
Measured: 7 days
Blood loss
Chest-tube drainage at 6 and 24 hours after surgery
Measured: 24 hours
Ventilation and hospital stay
Duration of mechanical ventilation and length of stay in the ICU and hospital
Measured: 24 hours to 7 days
Kidney injury
Incidence of acute kidney injury, defined as a ≥ 2-fold in increase in creatinine or new renal replacement therapy within 48 hours after surgery
Measured: 48 hours
Post operative complications
Arrhythmias, sternal infection, myocardial infarction, stroke, thromboembolic events, and death
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2014 (estimated)
- Study startOct 2014
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart DiseasesStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7,402 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jo Carroll, University Health Network, Toronto
- Investigators
- Keyvan Karkouti, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02200419
- Sponsor's protocol ID
- 14-7495-A
- Acronym
- TACS
- Status last verified
- Dec 2016
- First submitted
- 20 Jun 2014
- Last updated
- 5 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Karkouti K, Callum J, Wijeysundera DN, Rao V, Crowther M, Grocott HP, Pinto R, Scales DC; TACS Investigators. Point-of-Care Hemostatic Testing in Cardiac Surgery: A Stepped-Wedge Clustered Randomized Controlled Trial. Circulation. 2016 Oct 18;134(16):1152-1162. doi: 10.1161/CIRCULATIONAHA.116.023956. Epub 2016 Sep 21.
PubMed 27654344
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Conservation in Cardiac Surgery Using a Novel Transfusion Algorithm Based on Point-of-care Testing-A Stepped-wedge Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02200419
- Acronym / sponsor ID
- TACS / 14-7495-A
- Conditions
- Heart Diseases
- Keywords
- Rotem, Point of care coagulation tests, Cardiac surgery, Vascular surgery, Cardiopulmonary bypass, Blood products, Transfusion, Viscoelastic coagulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,402 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 25 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multi-centre study will provide sound, generalizable data on the effectiveness of a POC-based algorithm to determine to what extent this guideline can reduce blood product transfusions. Investigators will study outcomes in 7000 patients undergoing heart surgery at 10 participating hospitals. The proposed trial addresses several important research and clinical issues and has the potential to markedly improve the transfusion management and surgical care in general of cardiac surgery patients.
The intervention will be a novel POC-based algorithm that has been shown in a pilot study by us to be associated with a substantial reduction in blood product transfusions. The algorithm will employ viscoelastic and aggregometric POC-tests and an objective measure of blood loss. The primary outcome will be avoidance of red blood cell transfusion during hospitalization. The study has a 90% power to detect a 12% increase in avoidance rate. Secondary outcomes will include avoidance of red blood cell use and other blood products (plasma, platelets, and cryoprecipitate), units of blood products transfused, and adverse clinical outcomes related to transfusion (acute kidney injury, infections, and death). Data will also be collected for future health-economics analyses.
Largely due to the limitations of existing evidence, however, such algorithms are rarely used in clinical practice. The proposed trial will provide sound, generalizable data on the effectiveness of a POC-based algorithm to guide their future use. An integrated blood management algorithm that employs POC coagulation tests will reduce blood product transfusions in cardiac surgery, thereby improving clinical outcomes.
Does an integrated blood transfusion algorithm that employs POC coagulation tests applied across a network of hospitals reduce blood transfusions and associated adverse outcomes in cardiac surgery?
Detailed description
Despite major advances in cardiac surgery, coagulopathy continues to carry a heavy burden in cases that require the use of cardiopulmonary bypass (CPB), occurring frequently and resulting in excessive blood loss, blood product transfusions, and adverse clinical outcomes. Current management of coagulopathy is hampered by the inability of conventional laboratory tests to delineate its etiology in a timely manner, thereby precluding timely and targeted transfusion therapy. With the advent of point-of-care (POC) coagulation tests that can rapidly identify the etiology of coagulopathy, it may now be possible to reduce the burden of coagulopathy and thereby reduce transfusions and adverse outcomes. Several single-centre studies (including one by the investigator group) have found that the use of POC-based algorithms in cardiac surgery can markedly reduce blood product transfusions and by that means reduce morbidities and mortality.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transfusion Algorithm | Other | Other: POC-based transfusion algorithmHospitals will be randomized to the intervention arm of the study in a stratified manner. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| POC-based transfusion algorithmA transfusion algorithm based on point-of-care coagulation testing. | Other | Transfusion Algorithm |
Primary outcome
Point Of Care (POC) Transfusion Algorithm Cardiac Study
Time frame: 2.5 years
The primary outcome measure will be the proportion of patients who receive any allogeneic red blood cell (RBC) transfusion from admission before surgery to end of follow-up.
5 secondary outcomes
Transfusion
Time frame: 7 days
Blood loss
Time frame: 24 hours
Ventilation and hospital stay
Time frame: 24 hours to 7 days
Kidney injury
Time frame: 48 hours
Post operative complications
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2016.
- Derived from this study: PubMed 27654344Karkouti K, Callum J, Wijeysundera DN, Rao V, Crowther M, Grocott HP, Pinto R, Scales DC; TACS Investigators. Point-of-Care Hemostatic Testing in Cardiac Surgery: A Stepped-Wedge Clustered Randomized Controlled Trial. Circulation. 2016 Oct 18;134(16):1152-1162. doi: 10.1161/CIRCULATIONAHA.116.023956. Epub 2016 Sep 21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keyvan Karkouti, MD principal investigator
University Health Network, Toronto
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing POC-based transfusion algorithm in people with Heart Diseases, run by University Health Network, Toronto at 12 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Point Of Care (POC) Transfusion Algorithm Cardiac Study (time frame: 2.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02200419, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2016.