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

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ClinicalTrials.gov Identifier: NCT02277379
Recruitment Status : Completed
First Posted : October 29, 2014
Last Update Posted : January 9, 2015
Sponsor:
Information provided by (Responsible Party):
Petricevic Mate, University of Zagreb

Brief 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.

Condition or disease
Heart Disease

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Study Type : Observational
Actual Enrollment : 113 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : September 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Transfusion requirements [ Time Frame: 5 days ]
    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.

  2. reexploration for bleeding [ Time Frame: 3 days ]
    Surgical reexploration of the mediastinum for excessive bleeding will be noted, along with any surgical explanation for the bleeding.


Other Outcome Measures:
  1. 30 day mortality [ Time Frame: 30 day ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients undergoing elective cardiac surgery procedures will be consecutively enrolled.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02277379


Locations
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Croatia
UHC Zagreb
Zagreb, Croatia, 10000
Sponsors and Collaborators
University of Zagreb
Investigators
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Principal Investigator: Mate Petricevic, M.D., Ph.D. Clinical Hospital Centre Zagreb
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Responsible Party: Petricevic Mate, M.D. , Ph.D., University of Zagreb
ClinicalTrials.gov Identifier: NCT02277379    
Other Study ID Numbers: KBCZG8.1-14/62-2
First Posted: October 29, 2014    Key Record Dates
Last Update Posted: January 9, 2015
Last Verified: January 2015
Keywords provided by Petricevic Mate, University of Zagreb:
cardiac surgery ; hemorrhage ; transfusion requirements
Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases