Assiut university hospital
Asyut, Egypt
Location status: Recruiting
NCT Number: NCT04910464
In this study, our aim is to investigate the role tranexamic acid in modulating inflammation in patients with sepsis.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Phase 3
Asyut, Egypt
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
administer the same volume (100ml normal saline) and same duration (first three days).
Other names: Normal saline
Time frame: 7days
Short-term ICU mortality within 7days of admission and intervention
Time frame: 4 days
From complete blood count, divide absolute number of neutrophils on lymphocyte to assess and follow up the inflammatory response in sepsis
Time frame: 4 days
Measurement of interleukin-6 (IL-6) serum level to assess and follow up the inflammatory response in sepsis
Time frame: 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
Time frame: 7 days
Days of patients admission in ICU
Time frame: 7 days
Days of patients admission in hospital
Contact information is provided by the study sponsor or research team.
Assiut University
Other
Could Early Tranexamic Acid Safely Serve as an Anti-inflammatory Treatment for Patients With Sepsis? A Randomized Double Blind Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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