Early Tranexamic Acid and Modulating the Inflammatory Response in Sepsis

Sepsis Clinical Trial

Official title:

Could Early Tranexamic Acid Safely Serve as an Anti-inflammatory Treatment for Patients With Sepsis? A Randomized Double Blind Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04910464
• Other study ID #: 17300607
• Status: Recruiting
• Phase: Phase 3
• Start date: June 5, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2024
• Source: Assiut University
• Contact: Omar Soliman
• Phone: 01101266040
• Email: omarmakram347[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 30, 2024
• Est. primary completion date: June 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

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)

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Intervention

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

Country	Name	City	State
Egypt	Assiut university hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ICU mortality	Short-term ICU mortality within 7days of admission and intervention	7days
Secondary	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
Secondary	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
Secondary	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
Secondary	ICU stay	Days of patients admission in ICU	7 days
Secondary	Length of hospitalization	Days of patients admission in hospital	7 days