This trial is active, not recruiting.

Condition sepsis
Treatment aspirin
Phase phase 2
Sponsor Federal University of São Paulo
Start date June 2013
End date March 2016
Trial size 150 participants
Trial identifier NCT01784159, EPM81449


Platelet activation is an important factor in the pathogenesis of microvascular thrombosis characteristic of infections. Microthrombosis may be related to the progression of dysfunction during sepsis. Several drugs were tested in order to directly regulate blood clotting. However, there is a lack of studies on aspirin use in sepsis. Observational studies have demonstrated a decreased morbidity and mortality of sepsis with previous use of aspirin. However, no prospective randomized studies regarding this intervention were done. The objectives of this study are to evaluate the impact of the use of aspirin in reducing organ dysfunction measured by SOFA score on the seventh day, and assess its effect on the duration of mechanical ventilation, ICU and hospital stay, as well as platelet activity, inflammatory and prothrombotic activity. Thus, adult patients with severe sepsis and / or septic shock with less than 48 hours will be randomly allocated into two groups. Group 1 (ASA) will receive aspirin 200 mg and Group 2, placebo either once daily for 14 days. The inflammatory status and coagulation will be collected either in the D0 and D3, with measurements of interleukin 6, interleukin 10 and interleukin-8. The coagulation profile will be analyzed by measuring thrombin-antithrombin complex, thrombin time, d-dimer and tissue factor. The platelet activity will be evaluated by testing platelet function (PFA) and by measurement of urinary metabolites and thromboxane.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
(Placebo Comparator)
Placebo 1tb / day/ 7days
aspirin AAS
Aspirin administration for 7 days
(Active Comparator)
Intervention aspirin 200 mg/day for 7 days
aspirin AAS
Aspirin administration for 7 days

Primary Outcomes

reduction of organ dysfunction measured by SOFA score
time frame: 7 days

Secondary Outcomes

lenght of mechanical ventilation
time frame: 28 days

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patients over 18 years - Diagnosis of severe sepsis and / or septic shock with less than 48 hours - Signature of informed consent Exclusion Criteria: - Pregnancy - Inability to use the intestinal tract - Perspective of death in less than 24 hours - Restrictions on investment by the attending physician - diseases requiring the previous use of ASA - Patients with active bleeding - Participation in prior studies - Use of another investigational medication in the last 30 days - Allergy known aspirin - Presence of active peptic ulcer disease - Previous use of antiplatelet agents in the last 7 days - Patients with high risk of bleeding is defined by the presence of at least one of the following criteria: - Platelets <30,000 cells/mm3 - Hemorrhagic stroke in the last 30 days or surgery in the central nervous system in the last 72 hours. - Major surgery within the last 24 hours, if the assistant surgeon deems the risk of bleeding is high. - Liver cirrhosis or liver disease with altered prothrombin activity, manifested by INR above 2.0 or other coagulopathies. - Severe head trauma in the last 7 days. - Presence of an epidural catheter.

Additional Information

Official title Phase 2 Study of Aspirin Administration for Patients With Severe Sepsis and Septic Shock
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Federal University of São Paulo.