RecruitingPhase 3NCT04910464

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

Sponsor

Assiut University

Enrollment

80 participants

Start Date

Jun 5, 2021

Study Type

INTERVENTIONAL

Conditions

Sepsis

Summary

In this study, our aim is to investigate the role tranexamic acid in modulating inflammation in patients with sepsis.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria2

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 Criteria8

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)

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Interventions

DRUGTranexamic 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.

OTHER0.9% saline

administer the same volume (100ml normal saline) and same duration (first three days).