Single Dose Enteral Tranexamic Acid in Critically Ill Patients
This study is currently recruiting participants.
Verified September 2012 by San Diego Veterans Healthcare System
Sponsor:
San Diego Veterans Healthcare System
Collaborator:
Inflammagen/Leading Ventures
Information provided by (Responsible Party):
Erik B. Kistler, MD, PhD, San Diego Veterans Healthcare System
ClinicalTrials.gov Identifier:
NCT01683747
First received: September 9, 2012
Last updated: September 11, 2012
Last verified: September 2012
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Purpose
The premise of this study is that enteral tranexamic acid will help to maintain small bowel integrity, which is often compromised by critical illness due to inadequate cardiovascular perfusion (i.e., shock), and that maintenance of small bowel integrity will decrease morbidity in critically ill patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Shock Sepsis Hypotension Critical Illness |
Drug: Tranexamic Acid |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Single Dose Enteral Tranexamic Acid for the Reduction of Morbidity in Hospitalized Critically Ill Patients |
Resource links provided by NLM:
Further study details as provided by San Diego Veterans Healthcare System:
Primary Outcome Measures:
- Morbidity [ Time Frame: 28 days ] [ Designated as safety issue: No ]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]
Secondary Outcome Measures:
- morbidity [ Time Frame: 6 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]All-cause death will be measured at 28 days
- mortality [ Time Frame: 6 months ] [ Designated as safety issue: No ]All cause mortality will be measured at 6 months
- ICU length of stay [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]Time spent as a patient in the ICU will be measured
- Hospital length of stay [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]Time spent in the hospital as a patient will be measured
| Estimated Enrollment: | 200 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | January 2015 |
| Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Tranexamic acid
Study group receives enteral tranexamic acid in normal saline in addition to usual care.
|
Drug: Tranexamic Acid
Other Name: Cyclokapron
|
|
Placebo Comparator: Control group
Control group receives vehicle (normal saline) without study drug and usual care.
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01683747
Contacts
| Contact: Erik B Kistler, MD, PhD | 858-642-3150 | ekistler@ucsd.edu |
Locations
| United States, California | |
| VA San Diego Health Care System | Recruiting |
| San Diego, California, United States, 92161 | |
| Contact: Erik B Kistler, MD, PhD 858-642-3150 ekistler@ucsd.edu | |
| Principal Investigator: Erik B Kistler, MD, PhD | |
Sponsors and Collaborators
San Diego Veterans Healthcare System
Inflammagen/Leading Ventures
Investigators
| Principal Investigator: | Erik B Kistler, MD, PhD | VA San Diego Healthcare/University of California, San Diego |
More Information
No publications provided
| 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 |
| Study First Received: | September 9, 2012 |
| Last Updated: | September 11, 2012 |
| Health Authority: | United States: Federal Government United States: Data and Safety Monitoring Board United States: Institutional Review Board United States: VA Research & Development Committee |
Keywords provided by San Diego Veterans Healthcare System:
|
sepsis shock placebo controlled double blinded interventional |
Additional relevant MeSH terms:
|
Critical Illness Hypotension Sepsis Shock Disease Attributes Pathologic Processes Vascular Diseases Cardiovascular Diseases Infection Systemic Inflammatory Response Syndrome |
Inflammation Tranexamic Acid Antifibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Hemostatics Coagulants Hematologic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013