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

NCT06961175 | Recruiting DMC

• 1 other identifier: PI 2025 03 1850
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Platelet Disorders; Cardiac Surgery; Postoperative Bleeding

Outcome Measures

Primary Outcomes (1)

• Amount of postoperative bleeding

  Amount of blood collected in drains after cardiac surgery

  24 hours

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León: lead

Study Sites (1)

Salamanca University Hospital

Salamanca, 37007, Spain

RECRUITING

MeSH Terms

Conditions

Blood Platelet Disorders; Postoperative Hemorrhage

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications

Study Officials

• José A. Sastre

  Salamanca University Hospital

  STUDY DIRECTOR

Central Study Contacts

José A. Sastre

CONTACT

0034923291100; jasastre@saludcastillayleon.es

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 7, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)