Heart DiseaseNCT02277379
Prediction of Bleeding and Transfusion Outcomes and Assessment of Perioperative Platelet Reactivity in Cardiac Surgery
An observational study of Heart Disease, run by University of Zagreb at 1 site in Croatia.
Trial summary
Excessive bleeding after cardiopulmonary bypass (CPB) operations remains to be a persistent problem. Antiplatelet therapy (APT) is an integral component of perioperative management in patients undergoing cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Disease
- How many people
- 113 participants
- Where
- 1 siteCroatia
- Study dates
- Sep 2014to Jan 2015
- Phase
- Observational
- 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
Study population: Adult patients undergoing elective cardiac surgery procedures will be consecutively enrolled.
Who may be able to join
- > 18 years old
- Elective cardiac surgery patients
- Coronary artery disease
- Aortic valve disease
- Mitral valve disease
- Ascendent aorta aneurysm
- Combine coronary and valve disease
- Cardiac surgery procedures using cardiopulmonary bypass
Who cannot join
- Missing consent
- Patients with emergent cardiac surgical procedures
- Patients on antiplatelet therapy other than aspirin , clopidogrel and prasugrel
- Patients with inaccurate antiplatelet therapy administration documentation
- Missing data
- Off-pump procedures
Show all 9Show fewer
- Patients younger than 18 years old
- Patients with severe mental disorders
- Intrinsic coagulopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prediction of Bleeding Outcomes / Transfusion Requirements and Assessment of Perioperative Changes in Platelet Reactivity Using Point-of-care Platelet Function Testing in Patients Undergoing Cardiac Surgery
Excessive bleeding after cardiopulmonary bypass (CPB) operations remains to be a persistent problem. Antiplatelet therapy (APT) is an integral component of perioperative management in patients undergoing cardiac surgery. The impact of drug induced platelet inhibition on early postoperative bleeding extent and transfusion requirements remains difficult to predict.
In addition to, resistance to antiplatelet drugs as well as perioperative increase in platelet reactivity following CPB has been reported but this phenomenon has to be comprehensively investigated.
Read more
The best point-of-care platelet function test to predict bleeding complications/transfusion requirements remains unclear. In addition to, the best test platelet function test to monitor resistance to antiplatelet therapy and its impact on clinical outcomes remains elusive.
The aim of this study is:
- to compare two point-of-care platelet function analyzers (Multiplate and ROTEM Platelet) in regard to prediction of bleeding complications/trasfusion requirements.
- to compare two point-of-care platelet function analyzers (Multiplate and ROTEM Platelet) in regard to detection of high "on-treatment" platelet reactivity both pre- and postoperatively.
Read the detailed description
Excessive bleeding after cardiopulmonary bypass (CPB) operations remains to be a persistent problem. Antiplatelet therapy (APT) is an integral component of perioperative management in patients undergoing cardiac surgery. The impact of drug induced platelet inhibition on early postoperative bleeding extent and transfusion requirements remains difficult to predict.
In addition to, resistance to antiplatelet drugs as well as perioperative increase in platelet reactivity following CPB has been reported but this phenomenon has to be comprehensively investigated.
The best point-of-care platelet function test to predict bleeding complications/transfusion requirements remains unclear. In addition to, the best test platelet function test to monitor resistance to antiplatelet therapy and its impact on clinical outcomes remains elusive.
The aim of this study is:
- to compare two point-of-care platelet function analyzers (Multiplate and ROTEM Platelet) in regard to prediction of bleeding complications/trasfusion requirements. Three different tests will be performed on each device simultaneously at three time points: T1) Preoperative testing will include ASPI test, ADP test and TRAP test for Multiplate device and ARATEM, ADPTEM and TRAPTEM for ROTEM Platelet device, respectively. T2) After declamping of the aorta: ASPI test, ADP test and TRAP test for Multiplate device and ARATEM, ADPTEM and TRAPTEM for ROTEM Platelet device will be performed. T3) 5-10 minutes after protamine administration: ASPI test, ADP test and TRAP test for Multiplate device and ARATEM, ADPTEM and TRAPTEM for ROTEM Platelet device will be performed. Results obtained with this two platelet function point-of-care devices at the first three timepoints will be tested for correlations with postoperative bleeding amount and intra/postoperative transfusion requirements. Predictibalility of bleeding complications as well as transfusion requirements will be compared between Multiplate tests and ROTEM Platelet tests.
- to compare two point-of-care platelet function analyzers (Multiplate and ROTEM Platelet) in regard to detection of high "on-treatment" platelet reactivity both pre- and postoperatively.
To compare Multiplate and ROTEM Platelet for assessment of high on treatment platelet reactivity we will use tests being performed preoperatively (T1) and tests performed at fourth postoperative day (T4).
ASPI test (Multiplate) and ARATEM test (ROTEM Platelet) are sensitive to the platelet inhibitory effect of acetylsalicylic acid. Thus, the incidence of resistance to acetylsalicylic acid , measured by Multiplate ASPI test and ROTEM Platelet ARATEM will be compared between device measurements performed at T1 and T4, respectively. Specific subanalysis will be performed for ARATEM test with aim to make laboratory based definition of resistance to acetylsalicylic acid. Specific cut-of value for acetylsalicylic acid resistance has already been defined by our working group for Multiplate ASPI test.
ADP test (Multiplate) and ADPTEM test (ROTEM Platelet) are sensitive to the effect of thienopyridines. For patients being preoperatively exposed to thienopyridines, measurements of Multiplate ADP test and ROTEM Platelet ADPTEM test will be performed at T1 with aim to compare the incidence of high on-treatment platelet reactivity.
Preoperative (T1) and postoperative (T4) measurements obtained with Multiplate and ROTEM Platelet will be compared. Perioperative increase in platelet reactivity will be evaluated.
- Conditions
- Heart Disease
- Keywords
- cardiac surgery ; hemorrhage ; transfusion requirements
- Medical subject headings
- Heart Diseases, Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative chest tube output
Chest tube output (CTO) was determined as study's primary outcome. To estimate blood loss, we will meticulously document CTO, in first 24 postoperative hours and divide it by patient's weight. Drainage loss will be assessed after completion of a 30-minute stabilization period. Blood loss during the stabilization period will not be included in the definition of postoperative hemorrhage. Such loss may be caused by postural changes when transferring the patient from the operating room table to the bed or because of fluid in the pleural or mediastinal cavity, which may have arisen from the rinsing with water as an attempt to achieve surgical hemostasis.
Measured: the first 24 postoperative hours
Secondary outcomes (2)
Transfusion requirements
Intraoperative and postoperative transfusion requirements (packed red blood cells in mL, fresh frozen plasma in mL, fibrinogen concentrate in grams and platelet concentrates in units) will be determined as study's secondary outcome.
Measured: 5 days
reexploration for bleeding
Surgical reexploration of the mediastinum for excessive bleeding will be noted, along with any surgical explanation for the bleeding.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zagreb
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Petricevic Mate, University of Zagreb
- Investigators
- Mate Petricevic, M.D., Ph.D., Principal investigator, Clinical Hospital Centre Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02277379
- Sponsor's protocol ID
- KBCZG8.1-14/62-2
- Status last verified
- Jan 2015
- First submitted
- 26 Oct 2014
- Last updated
- 9 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Bleeding Outcomes / Transfusion Requirements and Assessment of Perioperative Changes in Platelet Reactivity Using Point-of-care Platelet Function Testing in Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02277379
- Acronym / sponsor ID
- KBCZG8.1-14/62-2
- Conditions
- Heart Disease
- Keywords
- cardiac surgery ; hemorrhage ; transfusion requirements
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- University of ZagrebUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 29 Oct 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.
Excessive bleeding after cardiopulmonary bypass (CPB) operations remains to be a persistent problem. Antiplatelet therapy (APT) is an integral component of perioperative management in patients undergoing cardiac surgery. The impact of drug induced platelet inhibition on early postoperative bleeding extent and transfusion requirements remains difficult to predict.
In addition to, resistance to antiplatelet drugs as well as perioperative increase in platelet reactivity following CPB has been reported but this phenomenon has to be comprehensively investigated.
The best point-of-care platelet function test to predict bleeding complications/transfusion requirements remains unclear. In addition to, the best test platelet function test to monitor resistance to antiplatelet therapy and its impact on clinical outcomes remains elusive.
The aim of this study is:
- to compare two point-of-care platelet function analyzers (Multiplate and ROTEM Platelet) in regard to prediction of bleeding complications/trasfusion requirements.
- to compare two point-of-care platelet function analyzers (Multiplate and ROTEM Platelet) in regard to detection of high "on-treatment" platelet reactivity both pre- and postoperatively.
Detailed description
Excessive bleeding after cardiopulmonary bypass (CPB) operations remains to be a persistent problem. Antiplatelet therapy (APT) is an integral component of perioperative management in patients undergoing cardiac surgery. The impact of drug induced platelet inhibition on early postoperative bleeding extent and transfusion requirements remains difficult to predict.
In addition to, resistance to antiplatelet drugs as well as perioperative increase in platelet reactivity following CPB has been reported but this phenomenon has to be comprehensively investigated.
The best point-of-care platelet function test to predict bleeding complications/transfusion requirements remains unclear. In addition to, the best test platelet function test to monitor resistance to antiplatelet therapy and its impact on clinical outcomes remains elusive.
The aim of this study is:
- to compare two point-of-care platelet function analyzers (Multiplate and ROTEM Platelet) in regard to prediction of bleeding complications/trasfusion requirements. Three different tests will be performed on each device simultaneously at three time points: T1) Preoperative testing will include ASPI test, ADP test and TRAP test for Multiplate device and ARATEM, ADPTEM and TRAPTEM for ROTEM Platelet device, respectively. T2) After declamping of the aorta: ASPI test, ADP test and TRAP test for Multiplate device and ARATEM, ADPTEM and TRAPTEM for ROTEM Platelet device will be performed. T3) 5-10 minutes after protamine administration: ASPI test, ADP test and TRAP test for Multiplate device and ARATEM, ADPTEM and TRAPTEM for ROTEM Platelet device will be performed. Results obtained with this two platelet function point-of-care devices at the first three timepoints will be tested for correlations with postoperative bleeding amount and intra/postoperative transfusion requirements. Predictibalility of bleeding complications as well as transfusion requirements will be compared between Multiplate tests and ROTEM Platelet tests.
- to compare two point-of-care platelet function analyzers (Multiplate and ROTEM Platelet) in regard to detection of high "on-treatment" platelet reactivity both pre- and postoperatively.
To compare Multiplate and ROTEM Platelet for assessment of high on treatment platelet reactivity we will use tests being performed preoperatively (T1) and tests performed at fourth postoperative day (T4).
ASPI test (Multiplate) and ARATEM test (ROTEM Platelet) are sensitive to the platelet inhibitory effect of acetylsalicylic acid. Thus, the incidence of resistance to acetylsalicylic acid , measured by Multiplate ASPI test and ROTEM Platelet ARATEM will be compared between device measurements performed at T1 and T4, respectively. Specific subanalysis will be performed for ARATEM test with aim to make laboratory based definition of resistance to acetylsalicylic acid. Specific cut-of value for acetylsalicylic acid resistance has already been defined by our working group for Multiplate ASPI test.
ADP test (Multiplate) and ADPTEM test (ROTEM Platelet) are sensitive to the effect of thienopyridines. For patients being preoperatively exposed to thienopyridines, measurements of Multiplate ADP test and ROTEM Platelet ADPTEM test will be performed at T1 with aim to compare the incidence of high on-treatment platelet reactivity.
Preoperative (T1) and postoperative (T4) measurements obtained with Multiplate and ROTEM Platelet will be compared. Perioperative increase in platelet reactivity will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing elective cardiac surgery procedures will be consecutively enrolled.
Key inclusion criteria (8 listed)
- > 18 years old
- Elective cardiac surgery patients
- Coronary artery disease
- Aortic valve disease
- Mitral valve disease
Key exclusion criteria (9 listed)
- Missing consent
- Patients with emergent cardiac surgical procedures
- Patients on antiplatelet therapy other than aspirin , clopidogrel and prasugrel
- Patients with inaccurate antiplatelet therapy administration documentation
- Missing data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
postoperative chest tube output
Time frame: the first 24 postoperative hours
Chest tube output (CTO) was determined as study's primary outcome. To estimate blood loss, we will meticulously document CTO, in first 24 postoperative hours and divide it by patient's weight. Drainage loss will be assessed after completion of a 30-minute stabilization period. Blood loss during the stabilization period will not be included in the definition of postoperative hemorrhage. Such loss may be caused by postural changes when transferring the patient from the operating room table to the bed or because of fluid in the pleural or mediastinal cavity, which may have arisen from the rinsing with water as an attempt to achieve surgical hemostasis.
2 secondary outcomes
Transfusion requirements
Time frame: 5 days
reexploration for bleeding
Time frame: 3 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 9 Jan 2015.
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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.
Mate Petricevic, M.D., Ph.D. principal investigator
Clinical Hospital Centre Zagreb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Disease, run by University of Zagreb at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. 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 9 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. 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?
postoperative chest tube output (time frame: the first 24 postoperative hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jan 2015.