Prediction of Bleeding and Transfusion Outcomes and Assessment of Perioperative Platelet Reactivity in Cardiac Surgery

Heart Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02277379
• Other study ID #: KBCZG8.1-14/62-2
• Status: Completed
• Phase: N/A
• First received: October 26, 2014
• Last updated: January 8, 2015
• Start date: September 2014
• Est. completion date: January 2015

Study information

• Verified date: January 2015
• Source: University of Zagreb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Croatia: Ethics Committee
• Study type: Observational

Clinical 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. 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:

1. to compare two point-of-care platelet function analyzers (Multiplate and ROTEM Platelet) in regard to prediction of bleeding complications/trasfusion requirements.

2. 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.

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:

1. 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.

2. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. > 18 years old

2. Elective cardiac surgery patients

3. Coronary artery disease

4. Aortic valve disease

5. Mitral valve disease

6. Ascendent aorta aneurysm

7. Combine coronary and valve disease

8. Cardiac surgery procedures using cardiopulmonary bypass

Exclusion Criteria:

1. Missing consent

2. Patients with emergent cardiac surgical procedures

3. Patients on antiplatelet therapy other than aspirin , clopidogrel and prasugrel

4. Patients with inaccurate antiplatelet therapy administration documentation

5. Missing data

6. Off-pump procedures

7. Patients younger than 18 years old

8. Patients with severe mental disorders

9. Intrinsic coagulopathy

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Disease

Locations

Country	Name	City	State
Croatia	UHC Zagreb	Zagreb

Sponsors (1)

Lead Sponsor	Collaborator
University of Zagreb

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	30 day mortality	Patient follow up will be performed regularly as a part of a clinical routine protocol. The occurence of mortality within 30 day will be noted	30 day	No
Primary	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.	the first 24 postoperative hours	No
Secondary	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.	5 days	No
Secondary	reexploration for bleeding	Surgical reexploration of the mediastinum for excessive bleeding will be noted, along with any surgical explanation for the bleeding.	3 days	No