Early Tranexamic Acid and Modulating the Inflammatory Response in Sepsis

NCT ID: NCT04910464

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-05
• Study Completion Date: 2027-01-30

Brief Summary

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.

Conditions

Sepsis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Tranexamic acid

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.

Group Type: EXPERIMENTAL

Tranexamic acid

Intervention Type: 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.

Saline placebo

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

Group Type: PLACEBO_COMPARATOR

0.9% saline

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: DRUG

0.9% saline

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

Intervention Type: OTHER

Other Intervention Names

Cyclokapron; Normal saline

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Omar Makram Soliman

Lecturer of anesthesia and ICU

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Omar Soliman, MD

Role: PRINCIPAL_INVESTIGATOR

Omar makram

Locations

Assiut university hospital

Asyut, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Omar Soliman

Role: CONTACT

omarmakram347@yahoo.com

01101266040

Other Identifiers

17300607

Identifier Type: -

Identifier Source: org_study_id