RecruitingNCT06961175

Observational Study of Platelet Dysfunction Assessed by Thromboelastography in Cardiovascular Surgery (DISPLATEG)

Observational Study of Preoperative or Extracorporeal Circulation-induced Platelet Dysfunction Assessed by Thromboelastography in Non-antiplatelet-treated Patients Undergoing Cardiovascular Surgery (DISPLATEG Study)


Sponsor

Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León

Enrollment

180 participants

Start Date

May 1, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

Perioperative bleeding requiring blood transfusion is common during cardiovascular surgery, especially in procedures requiring cardiopulmonary bypass. Adenosine diphosphate (ADP) plays a fundamental role in platelet function. Several studies have shown that some patients not receiving antiplatelet therapy undergoing cardiovascular surgery have decreased platelet ADP receptor activity; the prevalence of this condition can be as high as 36%. Furthermore, extracorporeal circulation itself has been shown to cause a reduction in platelet function. Platelet dysfunction due to reduced platelet receptor activity after cardiac surgery is potentially a common cause of bleeding, perioperative blood transfusion, and surgical reexploration in patients not receiving antiplatelet agents. However, these studies are conducted with few patients and present some contradictory results, so the evidence is still scarce. The study hypothesis is that preoperative platelet dysfunction for ADP measured by TEG® Platelet Mapping™ is associated with a higher incidence of moderate-severe bleeding after CPB in patients undergoing cardiovascular surgery.


Eligibility

Min Age: 18 Years

Inclusion Criteria6

  • Over 18 years of age.
  • Patients undergoing elective surgery under CPB.
  • Patients must be duly informed and have signed the informed consent form.
  • ASA status I-IV.
  • Sufficient intellectual capacity to understand the procedure.
  • Normal preoperative coagulation study and platelet count.

Exclusion Criteria4

  • Failure to meet the criteria listed above.
  • Preoperative administration of antiplatelet agents with an inadequate washout period (5 days for clopidogrel and ticagrelor and 7 days for plasugrel).
  • Preoperative administration of anticoagulants with an inadequate washout period.
  • Thrombopenia \<100,000 platelets or anemia \<11 g/dL

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Locations(1)

Salamanca University Hospital

Salamanca, Spain

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NCT06961175


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