RECRUITINGPhase 3INTERVENTIONAL
Early Tranexamic Acid and Modulating the Inflammatory Response in Sepsis
Could Early Tranexamic Acid Safely Serve as an Anti-inflammatory Treatment for Patients With Sepsis? A Randomized Double Blind Controlled Trial
About This Trial
In this study, our aim is to investigate the role tranexamic acid in modulating inflammation in patients with sepsis.
Who May Be Eligible (Plain English)
Who May Qualify:
- Adults (age 18-65 years) of American society of anesthesiologists (ASA) I-II who will be diagnosed with sepsis by qSOFA ≥2
- \& needed ICU admission.
Who Should NOT Join This Trial:
- Chronic renal failure
- Liver cirrhosis
- Bleeding disorders or current anticoagulant therapy
- Pregnancy or breastfeeding
- Impaired color vision
- Severe vascular ischemia, history of venous thrombosis \& pulmonary embolism
- Long term treatment with acetylsalicylic acid or non-steroidal anti-inflammatory drugs not discontinued before ICU admission
- Allergy to tranexamic acid (TXA)
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* Adults (age 18-65 years) of American society of anesthesiologists (ASA) I-II who will be diagnosed with sepsis by qSOFA ≥2
* \& needed ICU admission.
Exclusion Criteria:
* Chronic renal failure
* Liver cirrhosis
* Bleeding disorders or current anticoagulant therapy
* Pregnancy or breastfeeding
* Impaired color vision
* Severe vascular ischemia, history of venous thrombosis \& pulmonary embolism
* Long term treatment with acetylsalicylic acid or non-steroidal anti-inflammatory drugs not discontinued before ICU admission
* Allergy to tranexamic acid (TXA)
Treatments Being Tested
DRUG
Tranexamic acid
administer 1 gram of TXA in 100 ml of 0.9% normal saline, intravenous over 10 minutes as soon as possible but no later than three hours after diagnosis, infuse a second gram of TXA IV over 8 hours in 0.9% normal saline for first 3 days.
OTHER
0.9% saline
administer the same volume (100ml normal saline) and same duration (first three days).
Locations (1)
Assiut university hospital
Asyut, Egypt