Early Tranexamic Acid and Modulating the Inflammatory Response in Sepsis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tranexamic acid, 0.9% saline.
- Who it may be relevant to
- Registry conditions: Sepsis. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Could Early Tranexamic Acid Safely Serve as an Anti-inflammatory Treatment for Patients With Sepsis? A Randomized Double Blind Controlled Trial
Overview
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.
Interventions
- 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).
Primary outcome measures
- ICU mortality [Time frame: 7days]
Secondary outcome measures (5)
- Neutrophil/lymphocyte ratio (NLR) [Time frame: 4 days]
- Interleukin-6 (IL-6) serum level [Time frame: 4 days]
- Glasgow coma scale (GCS) [Time frame: 5 days]
- ICU stay [Time frame: 7 days]
- Length of hospitalization [Time frame: 7 days]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Assiut university hospital — Asyut
Identifiers
NCT: NCT04910464 · 17300607