Early Tranexamic Acid and Modulating the Inflammatory Response in Sepsis

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

Detailed Description
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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.

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

Conditions
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Sepsis

Intervention / Treatment
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* Drug: Tranexamic acid
* Other: 0.9% saline


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 |