An observational study in Blood Platelet Disorders, Cardiac Surgery and Postoperative Bleeding, sponsored by Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León · Observational
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.
Perioperative bleeding requiring blood transfusion is common during cardiovascular surgery, especially in procedures requiring cardiopulmonary bypass. Cardiac surgery is one of the groups that uses the most blood products, with 20% to 40% of patients requiring transfusions for routine procedures. Various publications have shown that these types of procedures consume between 10% and 15% of the blood supply in Western countries.
The etiology of bleeding and coagulopathy is generally multifactorial and may result from hemodilution, surgical losses, residual effects of anticoagulant and antiplatelet drugs, activation of tissue factor in the extrinsic system, contact activation of the intrinsic system in components of the extracorporeal circulation (ECC) circuit, and the presence of residual heparin after CPB. This process can lead to hyperfibrinolysis, reduced platelet count and function, decreased fibrinogen concentration, and depletion of coagulation factors, culminating in impaired thrombin generation. Surgical trauma and the CPB circuit itself produce an increase in inflammatory cytokines, interleukins, and tumor necrosis factor, which in turn contribute to increased release and activation of coagulation factors, as well as dysregulated fibrinolysis.
Adenosine diphosphate (ADP) plays a fundamental role in platelet function. When secreted from the platelet-dense granules where it is stored, it amplifies platelet responses induced by other platelet agonists and stabilizes platelet aggregates. 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%. In healthy blood donors, an average reduction in this activity of 18% has been shown, as measured by TEG® Platelet Mapping™ (Haemoscope Corporation, Niles, Illinois, USA) (0-58%). Furthermore, extracorporeal circulation itself has been shown to cause a reduction in platelet function, as measured by both the TEG® Platelet Mapping™ technique and aggregometry (Multiplate®). 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 both patients not receiving antiplatelet agents and those treated with clopidogrel. However, these studies were conducted with small numbers of patients and presented some contradictory results, so the evidence is still scarce.
47 studies on the registry are indexed under Blood Platelet Disorders; 9 are open to participants now.
This study's planned enrollment of 180 is above the median of 120 across 17 observational studies indexed under Blood Platelet Disorders.
Browse Blood Platelet Disorders studies →Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León is the lead sponsor of 15 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The population undergoing scheduled for cardiovascular surgery at the University Hospital of Salamanca will be taken as the reference population.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Amount of postoperative bleeding
Amount of blood collected in drains after cardiac surgery
Time frame: 24 hours
Plan to share: No
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Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León