Early Tranexamic Acid and Modulating the Inflammatory Response in Sepsis
Could Early Tranexamic Acid Safely Serve as an Anti-inflammatory Treatment for Patients With Sepsis? A Randomized Double Blind Controlled Trial
1 other identifier
interventional
80
1 country
1
Brief Summary
In this study, our aim is to investigate the role tranexamic acid in modulating inflammation in patients with sepsis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 sepsis
Started Jun 2021
Longer than P75 for phase_3 sepsis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 25, 2021
CompletedFirst Posted
Study publicly available on registry
June 2, 2021
CompletedStudy Start
First participant enrolled
June 5, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 10, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 30, 2027
August 5, 2025
August 1, 2025
5.6 years
May 25, 2021
August 3, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
ICU mortality
Short-term ICU mortality within 7days of admission and intervention
7days
Secondary Outcomes (5)
Neutrophil/lymphocyte ratio (NLR)
4 days
Interleukin-6 (IL-6) serum level
4 days
Glasgow coma scale (GCS)
5 days
ICU stay
7 days
Length of hospitalization
7 days
Study Arms (2)
Tranexamic acid
EXPERIMENTALGive 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.
Saline placebo
PLACEBO COMPARATORGive the same volume (100 ml normal saline) and same duration (first three days).
Interventions
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.
administer the same volume (100ml normal saline) and same duration (first three days).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assiut university hospital
Asyut, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Omar Soliman, MD
Omar makram
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of anesthesia and ICU
Study Record Dates
First Submitted
May 25, 2021
First Posted
June 2, 2021
Study Start
June 5, 2021
Primary Completion (Estimated)
January 10, 2027
Study Completion (Estimated)
January 30, 2027
Last Updated
August 5, 2025
Record last verified: 2025-08