Early Tranexamic Acid and Modulating the Inflammatory Response in Sepsis

Phase 3RecruitingNCT04910464

Assiut University80 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Sepsis

Interventions

Tranexamic acidDRUG

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.

0.9% salineOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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)

Locations (1)

Assiut university hospital

Asyut, Egypt

RECRUITING

Outcomes

Primary Outcomes

ICU mortality

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

Time frame: 7days

Secondary Outcomes

Neutrophil/lymphocyte ratio (NLR)

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

Interleukin-6 (IL-6) serum level

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

Time frame: 4 days

Glasgow coma scale (GCS)

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: 5 days

ICU stay

Days of patients admission in ICU

Time frame: 7 days

Length of hospitalization

Days of patients admission in hospital

Time frame: 7 days

Central Contacts

Omar Soliman

CONTACT

01101266040 omarmakram347@yahoo.com

Data from ClinicalTrials.gov

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