Early Tranexamic Acid and Modulating the Inflammatory Response in Sepsis

Assiut University

Status and phase: Enrolling; Phase 3

Conditions: Sepsis

Treatments: Other: 0.9% saline; Drug: Tranexamic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT04910464

17300607

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

Tranexamic acid

Experimental group

Description:

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.

Treatment:

Drug: Tranexamic acid

Saline placebo

Placebo Comparator group

Description:

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

Treatment:

Other: 0.9% saline