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.
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
- Conditions the study is for
- Blood Platelet Disorders, Cardiac Surgery, Postoperative Bleeding
- 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
- Recruiting
Salamanca University Hospital
Salamanca, 37007
José A. Sastre
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.
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.
- First posted7 May 2025
- Study start1 May 2025
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Platelet DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Alfonso Sastre, Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
- Investigators
- José A. Sastre, Study director, Salamanca University Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06961175
- Acronym / sponsor ID
- DISPLATEG / PI 2025 03 1850
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y LeónUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 7 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Amount of postoperative bleeding
Time frame: 24 hours
Amount of blood collected in drains after cardiac surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
José A. Sastre study director
Salamanca University Hospital
1 site in 1 country: see every site and its status.
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.