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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Saline placebo | Placebo Comparator | Give the same volume (100 ml normal saline) and same duration (first three days). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic acid | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| ICU mortality | Short-term ICU mortality within 7days of admission and intervention | 7days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4 days |
| Interleukin-6 (IL-6) serum level |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Omar Soliman | Contact | 01101266040 | omarmakram347@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Omar Soliman, MD | Omar makram | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assiut university hospital | Recruiting | Asyut | Egypt |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| 0.9% saline | Other | administer the same volume (100ml normal saline) and same duration (first three days). |
|
|
Measurement of interleukin-6 (IL-6) serum level to assess and follow up the inflammatory response in sepsis
| 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 | 5 days |
| ICU stay | Days of patients admission in ICU | 7 days |
| Length of hospitalization | Days of patients admission in hospital | 7 days |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D000077324 |
| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |