MedDataX Logo

Single Dose Enteral Tranexamic Acid in Critically Ill Patients

NCT ID: NCT01683747

Last Updated: 2015-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2014-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Shock Sepsis Hypotension Critical Illness

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Tranexamic acid

Study group receives enteral tranexamic acid in normal saline in addition to usual care.

Group Type EXPERIMENTAL

Tranexamic Acid

Intervention Type DRUG

Control group

Control group receives vehicle (normal saline) without study drug and usual care.

Group Type PLACEBO_COMPARATOR

Control Intervention (Carrier fluid only)

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tranexamic Acid

Intervention Type DRUG

Control Intervention (Carrier fluid only)

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Cyclokapron

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Inflammagen/Leading Ventures

UNKNOWN

Sponsor Role collaborator

San Diego Veterans Healthcare System

FED

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Erik B. Kistler, MD, PhD

Principal Investigator, Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Erik B Kistler, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

VA San Diego Healthcare/University of California, San Diego

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

VA San Diego Health Care System

San Diego, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

110376

Identifier Type: -

Identifier Source: org_study_id