Single Dose Enteral Tranexamic Acid in Critically Ill Patients
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ClinicalTrials.gov Identifier: NCT01683747 |
Recruitment Status
:
Terminated
(Lower than anticipated enrollment)
First Posted
: September 12, 2012
Last Update Posted
: November 17, 2015
|
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Condition or disease | Intervention/treatment | Phase |
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Shock Sepsis Hypotension Critical Illness | Drug: Tranexamic Acid Drug: Control Intervention (Carrier fluid only) | Phase 2 |
The primary objective of this study is to provide preliminary efficacy and safety data on the enteral administration of a one-time dose of tranexamic acid to critically ill patients for the reduction of morbidity at 28 days after enrollment in the study.
Secondary objectives of this study are to determine the efficacy of administration of enteral tranexamic acid in reducing intensive care unit (ICU) and hospital length-of-stay, as well and mortality and morbidity at 6 months.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 4 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Single Dose Enteral Tranexamic Acid for the Reduction of Morbidity in Hospitalized Critically Ill Patients |
Study Start Date : | June 2012 |
Actual Primary Completion Date : | November 2014 |
Actual Study Completion Date : | November 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: Tranexamic acid
Study group receives enteral tranexamic acid in normal saline in addition to usual care.
|
Drug: Tranexamic Acid
Other Name: Cyclokapron
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Placebo Comparator: Control group
Control group receives vehicle (normal saline) without study drug and usual care.
|
Drug: Control Intervention (Carrier fluid only) |
- Morbidity [ Time Frame: 28 days ]Morbidity will be assessed at 28 days as measured by the validated Self-Administered Quality of Well-being Scale (QWB-SA) and 5-Point modified Oxford Handicap Scale [secondary scale]
- morbidity [ Time Frame: 6 months ]Morbidity will be assessed at 28 days as measured by the validated Self-Administered Quality of Well-being Scale (QWB-SA) and 5-Point modified Oxford Handicap Scale [secondary scale]
- mortality [ Time Frame: 28 days ]All-cause death will be measured at 28 days
- mortality [ Time Frame: 6 months ]All cause mortality will be measured at 6 months
- ICU length of stay [ Time Frame: up to 6 months ]Time spent as a patient in the ICU will be measured
- Hospital length of stay [ Time Frame: up to 6 months ]Time spent in the hospital as a patient will be measured

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Critically ill patients admitted to ICU within 48 hours of onset of illness
- Patients with feeding tubes (e.g., orogastric, nasogastric, PEG, etc.)
Exclusion Criteria:
- primary admitting diagnosis of cancer
- primary admitting diagnosis of acute congestive heart failure
- primary admitting diagnosis of chronic obstructive pulmonary disease (COPD)
- primary admitting diagnosis of acute myocardial infarction or unstable cardiac arrythmia
- primary admitting diagnosis of amyotrophic lateral sclerosis (ALS) or other non-infectious disease
- primary admitting diagnosis of post-operative neurosurgical procedure
- known hypersensitivity to tranexamic acid
- acquired disturbances of color vision
- hematuria cause by disease of the renal parenchyma
- active thromboembolic disease such as deep venous thrombosis or pulmonary embolism
- patients with known clotting disorders or other known bleeding disorders
- recent (within 3 months) or active cerebrovascular bleed
- pregnancy
- inability to take study medicine (i.e., ileus with > 500ml stomach residuals, NPO status)
- patients excluded at the discretion of the treating physician

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01683747
United States, California | |
VA San Diego Health Care System | |
San Diego, California, United States, 92161 |
Principal Investigator: | Erik B Kistler, MD, PhD | VA San Diego Healthcare/University of California, San Diego |
Responsible Party: | Erik B. Kistler, MD, PhD, Principal Investigator, Assistant Professor, San Diego Veterans Healthcare System |
ClinicalTrials.gov Identifier: | NCT01683747 History of Changes |
Other Study ID Numbers: |
110376 |
First Posted: | September 12, 2012 Key Record Dates |
Last Update Posted: | November 17, 2015 |
Last Verified: | November 2015 |
Keywords provided by Erik B. Kistler, MD, PhD, San Diego Veterans Healthcare System:
sepsis shock placebo controlled double blinded interventional |
Additional relevant MeSH terms:
Sepsis Critical Illness Hypotension Infection Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes Disease Attributes |
Vascular Diseases Cardiovascular Diseases Tranexamic Acid Antifibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Hemostatics Coagulants |