NCT06961175 Observational Study of Platelet Dysfunction Assessed by Thromboelastography in Cardiovascular Surgery (DISPLATEG)
| NCT ID | NCT06961175 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León |
| Condition | Blood Platelet Disorders |
| Study Type | OBSERVATIONAL |
| Enrollment | 180 participants |
| Start Date | 2025-05-01 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 180 participants in total. It began in 2025-05-01 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
José A. Sastre
STUDY DIRECTOR
Salamanca University Hospital
Frequently Asked Questions
Who can join the NCT06961175 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Blood Platelet Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06961175 currently recruiting?
Yes, NCT06961175 is actively recruiting participants. Contact the research team at jasastre@saludcastillayleon.es for enrollment information.
Where is the NCT06961175 trial being conducted?
This trial is being conducted at Salamanca, Spain.
Who is sponsoring the NCT06961175 clinical trial?
NCT06961175 is sponsored by Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León. The principal investigator is José A. Sastre at Salamanca University Hospital. The trial plans to enroll 180 participants.