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Blood Platelet DisordersDISPLATEGNCT06961175

Observational Study of Platelet Dysfunction Assessed by Thromboelastography in Cardiovascular Surgery (DISPLATEG)

An observational study of Blood Platelet Disorders and Cardiac Surgery, run by Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León at 1 site in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
How many people
180 participants
Where
1 siteSpain
Study dates
1 May 2025to Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Spain1 site, 1 recruiting
  • Salamanca University Hospital

    Salamanca, 37007

    José A. Sastre

    Recruiting

Other trials in Spain

About this study

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)

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.

Read the detailed description

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.

Medical subject headings
Blood Platelet Disorders, Postoperative Hemorrhage

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Amount of postoperative bleeding

    Amount of blood collected in drains after cardiac surgery

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2025
  2. Study start1 May 2025
  3. Primary completionSep 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06961175
Sponsor's protocol ID
PI 2025 03 1850
Acronym
DISPLATEG
Status last verified
Sep 2026
First submitted
29 Apr 2025
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Blood Platelet Disorders and Cardiac Surgery, run by Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact José A. Sastre (0034923291100 ext. 55580, jasastre@saludcastillayleon.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Amount of postoperative bleeding (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.

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