Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2025-12-24 @ 3:02 PM
NCT ID:
NCT01784159
Eligibility Criteria:
Eligibility - patients:
Inclusion criteria:
The three criteria below must be present:
1. Signature of informed consent
2. Patients must be older than 18 years old
3. Diagnosis of sepsis and/or septic shock for less than 48 hours with at least one of the following organ dysfunctions:
* Lactate above 4mmol/L (36mg/dL)
* Thrombocytopenia \< 100,000/mm3 or reduction \> 50% in the count in the last 3 days
* PaO2/FiO2 \< 200 without signs of apparent volume overload
* Hypotension MAP \< 65mmHg refractory to volume replacement with the need to use vasopressor
* Acute renal injury increased by 2.0 to 2.9 times from baseline or diuresis rate less than 0.5ml/kg/h for more than 12 hours
Exclusion Criteria:
1. Pregnancy
2. Impossibility to use the intestinal tract
3. Death perspective in less than 24 hours
4. Patients in the end of their lives or in exclusive palliative care
5. Patients with active bleeding
6. Prior study participation
7. Known allergy to aspirin
8. Active peptic ulcer
9. Previous use of antiplatelet agents in the last 7 days
10. Previous use of AINEs in the last 7 days, except for dipyrone.
11. Hemorrhagic stroke in the last 7 days or central nervous system surgery in the last 72 hours.
12. Platelets \<30,000 cells/mm3.
13. Large surgery in the last 24 hours if the attending surgeon judges that the risk of bleeding is high enough that aspirin cannot be used.
14. Ophthalmologic surgery postoperative and transurethral resection of the prostate at the discretion of the attending physician.
15. Hepatic cirrhosis or previous liver disease with altered prothrombin activity, manifested by INR above 2.0 or other previous coagulopathies.
16. Severe head injury in the last 7 days.
17. Use or indication of anticoagulation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01784159
Study Brief:
Protocol Section:
NCT01784159