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Observational study of preoperative or extracorporeal circulation-induced platelet dysfunction assessed by thromboelastography in non-antiplatelet-treated patients undergoing cardiovascular surgery (DISPLATEG study)

NCT ID NCT06961175

NEW Sponsor: Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León Source: ClinicalTrials.gov ↗

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Paused for now. It may or may not start again.
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Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Sep 10, 2026 · Last updated Sep 10, 2026

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.

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Study facts

What this study's own registry entry says, in plain language.

Participants

About 180 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The population undergoing scheduled for cardiovascular surgery at the University Hospital of Salamanca will be taken as the reference population.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

blood platelet disease Postoperative Hemorrhage

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Blood platelet disorders Cardiac surgery Postoperative bleeding

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Salamanca University Hospital

    RECRUITING

    Salamanca, 37007, Spain

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