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NCT Number: NCT04910464

Early Tranexamic Acid and Modulating the Inflammatory Response in Sepsis

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Assiut university hospital

Asyut, Egypt

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Tranexamic Acid

Drug

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

0.9% saline

Other

administer the same volume (100ml normal saline) and same duration (first three days).

Other names: Normal saline

Primary outcomes

  1. ICU mortality

    Time frame: 7days

    Short-term ICU mortality within 7days of admission and intervention

Secondary outcomes

  1. Neutrophil/lymphocyte ratio (NLR)

    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

  2. Interleukin-6 (IL-6) serum level

    Time frame: 4 days

    Measurement of interleukin-6 (IL-6) serum level to assess and follow up the inflammatory response in sepsis

  3. Glasgow coma scale (GCS)

    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

  4. ICU stay

    Time frame: 7 days

    Days of patients admission in ICU

  5. Length of hospitalization

    Time frame: 7 days

    Days of patients admission in hospital

Study contacts

Contact information is provided by the study sponsor or research team.

Omar Soliman

CONTACT

[email protected]

01101266040

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Jun 2, 2021
Registry last updated
Aug 5, 2025

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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