NCT01683747

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 12, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

November 17, 2015

Status Verified

November 1, 2015

Enrollment Period

2.4 years

First QC Date

September 9, 2012

Last Update Submit

November 16, 2015

Conditions

ShockSepsisHypotensionCritical Illness

Keywords

sepsisshockplacebo controlleddouble blindedinterventional

Outcome Measures

Primary Outcomes (1)

  • 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 \[secondary scale\]

    28 days

Secondary Outcomes (5)

  • morbidity

    6 months

  • mortality

    28 days

  • mortality

    6 months

  • ICU length of stay

    up to 6 months

  • Hospital length of stay

    up to 6 months

Study Arms (2)

Tranexamic acid

EXPERIMENTAL

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

Drug: Tranexamic Acid

Control group

PLACEBO COMPARATOR

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

Drug: Control Intervention (Carrier fluid only)

Interventions

Tranexamic AcidDRUG
Also known as: Cyclokapron
Tranexamic acid
Control Intervention (Carrier fluid only)DRUG
Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Critically ill patients admitted to ICU within 48 hours of onset of illness
  • Patients with feeding tubes (e.g., orogastric, nasogastric, PEG, etc.)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA San Diego Health Care System

San Diego, California, 92161, United States

Location

MeSH Terms

Conditions

ShockSepsisHypotensionCritical Illness

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsInfectionsSystemic Inflammatory Response SyndromeInflammationVascular DiseasesCardiovascular DiseasesDisease Attributes

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Erik B Kistler, MD, PhD

    VA San Diego Healthcare/University of California, San Diego

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Assistant Professor

Study Record Dates

First Submitted

September 9, 2012

First Posted

September 12, 2012

Study Start

June 1, 2012

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

November 17, 2015

Record last verified: 2015-11

Locations

US(1)