Status:
COMPLETED
Pro-inflammatory Role of Blood Platelets in Critically Ill Patients With Septic Shock.
Lead Sponsor:
University Hospital, Bordeaux
Collaborating Sponsors:
MSD France
Conditions:
Septic Shock
Eligibility:
All Genders
18+ years
Brief Summary
Blood platelets play a major role in the inflammatory response. A dysregulation of platelets activation may be one of the contributors to tissue damage in critically ill patients with septic shock. Th...
Detailed Description
Sepsis is defined as life-threatening organ dysfunction due to dysregulated host response to infection which can lead to many failures of vital organs (kidneys, lungs, liver) in critically ill patient...
Eligibility Criteria
Inclusion
- Patients aged over 18 years admitted to an intensive care unit for:
- a septic shock evolving for less than 24h (defined by an increase in the SOFA (Sequential Organ Failure Assessment) score of at least 2 points related to an infection, a persisting hypotension requiring vasopressors to maintain MAP ≥65 mmHg and a serum lactate level \>2 mmol/L (18 mg/dL) despite adequate volume resuscitation)
- Or a systemic inflammatory response syndrome (SIRS) evolving for less than 24h (defined as 2 or more of the following variables: fever of more than 38°C or less than 36°C, heart rate of more than 90 beats per minute, respiratory rate of more than 20 breaths per minute or arterial carbon dioxide tension (PaCO2) of less than 32 mm Hg, abnormal white blood cell count (\>12,000/µL or \<4,000/µL or \>10% immature forms).
Exclusion
- Age \< 18 years
- Known history of constitutional thrombopathy (Bernard Soulier's disease, Glanzmann thrombasthenia, Gray's syndrome or dense granule disease)
- Myeloproliferative or myelodysplastic syndrome
- Autoimmune thrombocytopenic purpura
- Acute leukemia
- Haemorrhagic shock
- Platelet transfusion within 7 days prior to inclusion
- Antiplatelet medication (clopidogrel or ticagrelor taken within 5 days of inclusion, prasugrel or dipyridamole within 7 days of inclusion)
- Active HIV infection or known active hepatitis B or C
- Pregnant or breastfeeding woman
- Patients protected by the law, under guardianship or trusteeship, or deprived of liberty
- Patients without health insurance
Key Trial Info
Start Date :
November 9 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 25 2024
Estimated Enrollment :
202 Patients enrolled
Trial Details
Trial ID
NCT04080453
Start Date
November 9 2020
End Date
April 25 2024
Last Update
April 26 2024
Active Locations (1)
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1
Hôpital Haut Lévêque
Pessac, France, 33604