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Early Tranexamic Acid and Modulating the Inflammatory Response in Sepsis

Early Tranexamic Acid and Modulating the Inflammatory Response in Sepsis

Recruiting
18-65 years
All
Phase 3

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Overview

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

Description

A written informed consent will be taken from the patients or their relatives.Patients will be assigned randomly to two groups (40 subjects each) with qSOFA ≥2.

In (Group T) administer 1 gram of tranexamic acid (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 tranexamic acid (TXA) IV over 8 hours in 0.9% normal saline for the first 3 days. In (Group C) administer the same volume (100 ml normal saline)and same duration (first three days)for controlled patients.

Eligibility

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)

Study details
    Sepsis

NCT04910464

Assiut University

27 May 2024

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