Platelet ADP function and bleeding risk in adults having cardiac surgery with cardiopulmonary bypass
Official title: Observational Study of Preoperative or Extracorporeal Circulation-induced Platelet Dysfunction Assessed by Thromboelastography in Non-antiplatelet-treated Patients Undergoing Cardiovascular Surgery (DISPLATEG Study)
Run by Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León · NCT06961175 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 180 (estimated) |
| Sponsor | Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León Academic / other |
| Locations | 1 site (Salamanca) |
| Status | Recruiting |
| Started | May 1, 2025 |
| Main results expected | September 2026 |
| Study ends | December 2026 |
| Registry record updated | September 10, 2026 |
| Trial ID | NCT06961175 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Salamanca University Hospital
Salamanca, Spain Recruiting
Study contacts
- Study coordinator: José A. Sastre
- Email: jasastre@saludcastillayleon.es
- Phone: 0034923291100
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.