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Early Tranexamic Acid and Modulating the Inflammatory Response in Sepsis

Primary Purpose

Sepsis

Status
Recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Tranexamic acid
0.9% saline
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sepsis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Assiut university hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tranexamic acid

Saline placebo

Arm 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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Interleukin-6 (IL-6) serum level
Measurement of interleukin-6 (IL-6) serum level to assess and follow up the inflammatory response in sepsis
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
ICU stay
Days of patients admission in ICU
Length of hospitalization
Days of patients admission in hospital

Full Information

First Posted
May 25, 2021
Last Updated
April 11, 2023
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT04910464
Brief Title
Early Tranexamic Acid and Modulating the Inflammatory Response in Sepsis
Official Title
Could Early Tranexamic Acid Safely Serve as an Anti-inflammatory Treatment for Patients With Sepsis? A Randomized Double Blind Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 5, 2021 (Actual)
Primary Completion Date
June 10, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tranexamic acid
Arm Type
Experimental
Arm 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.
Arm Title
Saline placebo
Arm Type
Placebo Comparator
Arm Description
Give the same volume (100 ml normal saline) and same duration (first three days).
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid
Other Intervention Name(s)
Cyclokapron
Intervention Description
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
Other
Intervention Name(s)
0.9% saline
Other Intervention Name(s)
Normal saline
Intervention Description
administer the same volume (100ml normal saline) and same duration (first three days).
Primary Outcome Measure Information:
Title
ICU mortality
Description
Short-term ICU mortality within 7days of admission and intervention
Time Frame
7days
Secondary Outcome Measure Information:
Title
Neutrophil/lymphocyte ratio (NLR)
Description
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
Title
Interleukin-6 (IL-6) serum level
Description
Measurement of interleukin-6 (IL-6) serum level to assess and follow up the inflammatory response in sepsis
Time Frame
4 days
Title
Glasgow coma scale (GCS)
Description
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
Title
ICU stay
Description
Days of patients admission in ICU
Time Frame
7 days
Title
Length of hospitalization
Description
Days of patients admission in hospital
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Omar Soliman
Phone
01101266040
Email
omarmakram347@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Omar Soliman, MD
Organizational Affiliation
Omar makram
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut university hospital
City
Assiut
Country
Egypt
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Early Tranexamic Acid and Modulating the Inflammatory Response in Sepsis

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