ShockPhase 2NCT01683747
Single Dose Enteral Tranexamic Acid in Critically Ill Patients
A Phase 2 study testing Tranexamic Acid in people with Shock and Sepsis, run by San Diego Veterans Healthcare System at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shock, Sepsis, Hypotension
- What is being tested?
- Tranexamic Acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Nov 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Critically ill patients admitted to ICU within 48 hours of onset of illness
- Patients with feeding tubes (e.g., orogastric, nasogastric, PEG, etc.)
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VA San Diego Health Care System
San Diego, California, 92161
About this study
Official title: Single Dose Enteral Tranexamic Acid for the Reduction of Morbidity in Hospitalized Critically Ill Patients
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.
Read the 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.
- Conditions
- Shock, Sepsis, Hypotension, Critical Illness
- Being tested
- Tranexamic Acid, Control Intervention (Carrier fluid only)
- Keywords
- sepsis, shock, placebo controlled, double blinded, interventional
- Medical subject headings
- Shock, Sepsis, Hypotension, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
Also called Cyclokapron
Control Intervention (Carrier fluid only)Drug
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid | Experimental | Study group receives enteral tranexamic acid in normal saline in addition to usual care. Receives: Drug: Tranexamic Acid |
| Control group | Placebo comparator | Control group receives vehicle (normal saline) without study drug and usual care. Receives: Drug: Control Intervention (Carrier fluid only) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbidity
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]
Measured: 28 days
Secondary outcomes (5)
morbidity
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]
Measured: 6 months
mortality
All-cause death will be measured at 28 days
Measured: 28 days
mortality
All cause mortality will be measured at 6 months
Measured: 6 months
ICU length of stay
Time spent as a patient in the ICU will be measured
Measured: up to 6 months
Hospital length of stay
Time spent in the hospital as a patient will be measured
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2012 (estimated)
- Study startJun 2012
- Primary completionNov 2014
- Study completionNov 2014
Why it stopped: Lower than anticipated enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShockStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Diego Veterans Healthcare System
- Sponsor type
- US federal agency
- Collaborators
- Inflammagen/Leading Ventures
- Responsible party
- Principal investigator, Erik B. Kistler, MD, PhD, San Diego Veterans Healthcare System
- Investigators
- Erik B Kistler, MD, PhD, Principal investigator, VA San Diego Healthcare/University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01683747
- Sponsor's protocol ID
- 110376
- Status last verified
- Nov 2015
- First submitted
- 9 Sep 2012
- Last updated
- 17 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Dose Enteral Tranexamic Acid for the Reduction of Morbidity in Hospitalized Critically Ill Patients
- ClinicalTrials.gov ID
- NCT01683747
- Acronym / sponsor ID
- 110376
- Conditions
- Shock, Sepsis, Hypotension, Critical Illness
- Keywords
- sepsis, shock, placebo controlled, double blinded, interventional
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lower than anticipated enrollment
- Enrolment
- 4 participants (actual)
- Lead sponsor
- San Diego Veterans Healthcare SystemUS federal agency
- Collaborators
- Inflammagen/Leading Ventures
- Study start
- Jun 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 12 Sep 2012 (estimated)
- 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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid | Experimental | Drug: Tranexamic AcidStudy group receives enteral tranexamic acid in normal saline in addition to usual care. |
| Control group | Placebo comparator | Drug: Control Intervention (Carrier fluid only)Control group receives vehicle (normal saline) without study drug and usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Critically ill patients admitted to ICU within 48 hours of onset of illness
- Patients with feeding tubes (e.g., orogastric, nasogastric, PEG, etc.)
Key exclusion criteria (15 listed)
- 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
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: Cyclokapron | Drug | Tranexamic acid |
| Control Intervention (Carrier fluid only) | Drug | Control group |
Primary outcome
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]
5 secondary outcomes
morbidity
Time frame: 6 months
mortality
Time frame: 28 days
mortality
Time frame: 6 months
ICU length of stay
Time frame: up to 6 months
Hospital length of stay
Time frame: up to 6 months
Results and safety
The study was stopped early (reason given: Lower than anticipated enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2015.
Related trials for Shock
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
RecruitingObservational study
Hemophagocytic Lymphohistiocytosis (HLH) Evaluation and Research of Clinical, ImmUnoLogic and TranscriptomE Study
Lymphohistiocytosis, Hemophagocytic, Secondary Hemophagocytic Lymphohistiocytosis
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
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. This study is not recruiting at the moment.
Erik B Kistler, MD, PhD principal investigator
VA San Diego Healthcare/University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tranexamic Acid in people with Shock and Sepsis, run by San Diego Veterans Healthcare System at 1 site in United States.
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 15 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: stopped early, as of the sponsor's last update on 17 Nov 2015. 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lower than anticipated enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morbidity (time frame: 28 days). 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 17 Nov 2015.