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

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

Study Overview

• Status: Recruiting
• Conditions: Sepsis
• Intervention / Treatment: Drug: Tranexamic acid; Other: 0.9% saline

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Omar Soliman; Phone Number: 01101266040; Email: omarmakram347@yahoo.com

Study Locations

• Egypt
  • Assiut, Egypt
    • Recruiting
    • Assiut University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tranexamic acid; Give 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 the first 3 days.	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 Names: Cyclokapron
Placebo Comparator: Saline placebo; Give the same volume (100 ml normal saline) and same duration (first three days).	Other: 0.9% saline; administer the same volume (100ml normal saline) and same duration (first three days).; Other Names: Normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICU mortality	Short-term ICU mortality within 7days of admission and intervention	7days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neutrophil/lymphocyte ratio (NLR)	From complete blood count, divide absolute number of neutrophils on lymphocyte to assess and follow up the inflammatory response in sepsis	4 days
Interleukin-6 (IL-6) serum level	Measurement of interleukin-6 (IL-6) serum level to assess and follow up the inflammatory response in sepsis	4 days
Glasgow coma scale (GCS)	Assessing the conscious level of patients by Glasgow Coma Scale (3_15)after ICU admission and intervention start give an idea on brain dysfunction in sepsis where high scores are associated with low mortality and low scores are associated with high mortality	5 days
ICU stay	Days of patients admission in ICU	7 days
Length of hospitalization	Days of patients admission in hospital	7 days

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Omar Soliman, MD, Omar makram

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2021
• Primary Completion (Estimated): January 10, 2027
• Study Completion (Estimated): January 30, 2027

Study Registration Dates

• First Submitted: May 25, 2021
• First Submitted That Met QC Criteria: May 27, 2021
• First Posted (Actual): June 2, 2021

Study Record Updates

• Last Update Posted (Actual): August 5, 2025
• Last Update Submitted That Met QC Criteria: August 3, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia; Molecular Mechanisms of Pharmacological Action; Antifibrinolytic Agents; Fibrin Modulating Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: 17300607

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No