Platelet ADP function and bleeding risk in adults having cardiac surgery with cardiopulmonary bypass
Observational Study of Preoperative or Extracorporeal Circulation-induced Platelet Dysfunction Assessed by Thromboelastography in Non-antiplatelet-treated Patients Undergoing Cardiovascular Surgery (DISPLATEG Study)
Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León · NCT06961175
We will test whether a preoperative thromboelastography ADP test can predict which adults having elective cardiac surgery with cardiopulmonary bypass will bleed or need blood transfusions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León (other) |
| Locations | 1 site (Salamanca) |
| Trial ID | NCT06961175 on ClinicalTrials.gov |
What this trial studies
This observational study measures platelet ADP receptor activity using thromboelastography (TEG) in adults undergoing elective cardiac surgery with cardiopulmonary bypass. Eligible patients with normal preoperative coagulation and platelet counts will have a TEG-ADP test before surgery and be followed for perioperative bleeding, transfusion requirements, and surgical reexploration. Investigators will compare the prevalence of reduced ADP-related platelet function and its association with bleeding and transfusion outcomes. The goal is to clarify whether preoperative platelet dysfunction contributes to higher transfusion rates after bypass.
Who should consider this trial
Good fit: Adults (18+) scheduled for elective cardiac surgery with cardiopulmonary bypass who have normal preoperative coagulation and platelet counts and can provide informed consent.
Not a fit: Patients on antiplatelet or anticoagulant medications without adequate washout, those with thrombocytopenia or significant anemia, and emergency surgery patients are unlikely to benefit from the screening approach used in this protocol.
Why it matters
Potential benefit: If successful, the test could help identify patients at higher risk of bleeding so teams can tailor perioperative management to reduce transfusions.
How similar studies have performed: Prior small studies have reported reduced ADP receptor activity in some patients not on antiplatelet drugs and possible links to bleeding, but results have been inconsistent and the evidence remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Salamanca
- Salamanca University Hospital — Salamanca, Spain (RECRUITING)
Study contacts
- Study coordinator: José A. Sastre
- Email: jasastre@saludcastillayleon.es
- Phone: 0034923291100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Blood Platelet Disorders, Cardiac Surgery, Postoperative Bleeding