Early Tranexamic Acid and Modulating the Inflammatory Response in Sepsis

Phase 3

Recruiting

• Conditions: Sepsis
• Interventions: Other: 0.9% saline; Drug: Tranexamic acid

• Registration Number: NCT04910464
• Lead Sponsor: Assiut University

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-05-25
• Study First Submitted QC: 2021-05-27
• Study First Posted: 2021-06-02
• Study Start: 2021-06-05
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-07-31
• Primary Completion: 2025-01-10
• Study Completion: 2025-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline placebo	0.9% saline	Give the same volume (100 ml normal saline) and same duration (first three days).
Tranexamic acid	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.

Primary Outcome Measures

Name	Time	Method
ICU mortality	7days	Short-term ICU mortality within 7days of admission and intervention

Secondary Outcome Measures

Name	Time	Method
ICU stay	7 days	Days of patients admission in ICU
Glasgow coma scale (GCS)	5 days	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
Neutrophil/lymphocyte ratio (NLR)	4 days	From complete blood count, divide absolute number of neutrophils on lymphocyte to assess and follow up the inflammatory response in sepsis
Interleukin-6 (IL-6) serum level	4 days	Measurement of interleukin-6 (IL-6) serum level to assess and follow up the inflammatory response in sepsis
Length of hospitalization	7 days	Days of patients admission in hospital

Trial Locations

Locations (1)

Assiut university hospital; 🇪🇬 Assiut, Egypt