SepsisPhase 3NCT04910464
Early Tranexamic Acid and Modulating the Inflammatory Response in Sepsis
A Phase 3 study testing Tranexamic acid and 0.9% saline in people with Sepsis, run by Assiut University at 1 site in Egypt.
Trial summary
In this study, our aim is to investigate the role tranexamic acid in modulating inflammation in patients with sepsis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sepsis
- What is being tested?
- Tranexamic acid and 0.9% saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jun 2021to 30 Jan 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Could Early Tranexamic Acid Safely Serve as an Anti-inflammatory Treatment for Patients With Sepsis? A Randomized Double Blind Controlled Trial
In this study, our aim is to investigate the role tranexamic acid in modulating inflammation in patients with sepsis.
Read the 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
- Being tested
- Tranexamic acid, 0.9% saline
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acidDrug
Also called Cyclokapron
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
Also called Normal saline
administer the same volume (100ml normal saline) and same duration (first three days).
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid | Experimental | 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. Receives: Drug: Tranexamic acid |
| Saline placebo | Placebo comparator | Give the same volume (100 ml normal saline) and same duration (first three days). Receives: Other: 0.9% saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU mortality
Short-term ICU mortality within 7days of admission and intervention
Measured: 7days
Secondary outcomes (5)
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
Measured: 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
Measured: 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
Measured: 5 days
ICU stay
Days of patients admission in ICU
Measured: 7 days
Length of hospitalization
Days of patients admission in hospital
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study start5 Jun 2021
- Primary completion10 Jan 2027 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Makram Soliman, Assiut University
- Investigators
- Omar Soliman, MD, Principal investigator, Omar makram
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04910464
- Sponsor's protocol ID
- 17300607
- Status last verified
- Aug 2025
- First submitted
- 25 May 2021
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Could Early Tranexamic Acid Safely Serve as an Anti-inflammatory Treatment for Patients With Sepsis? A Randomized Double Blind Controlled Trial
- ClinicalTrials.gov ID
- NCT04910464
- Acronym / sponsor ID
- 17300607
- Conditions
- Sepsis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 5 Jun 2021 (actual)
- Primary completion
- 10 Jan 2027 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 2 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid | Experimental | Drug: Tranexamic acidGive 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. |
| Saline placebo | Placebo comparator | Other: 0.9% salineGive the same volume (100 ml normal saline) and same duration (first three days). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- Chronic renal failure
- Liver cirrhosis
- Bleeding disorders or current anticoagulant therapy
- Pregnancy or breastfeeding
- Impaired color vision
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic acidAlso: Cyclokapronadminister 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. | Drug | Tranexamic acid |
| 0.9% salineAlso: Normal salineadminister the same volume (100ml normal saline) and same duration (first three days). | Other | Saline placebo |
Primary outcome
ICU mortality
Time frame: 7days
Short-term ICU mortality within 7days of admission and intervention
5 secondary outcomes
Neutrophil/lymphocyte ratio (NLR)
Time frame: 4 days
Interleukin-6 (IL-6) serum level
Time frame: 4 days
Glasgow coma scale (GCS)
Time frame: 5 days
ICU stay
Time frame: 7 days
Length of hospitalization
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Omar Soliman, MD principal investigator
Omar makram
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tranexamic acid and 0.9% saline in people with Sepsis, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Omar Soliman (01101266040, omarmakram347@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU mortality (time frame: 7days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.