Single Dose Enteral Tranexamic Acid in Critically Ill Patients

Sepsis Clinical Trial

Official title:

Single Dose Enteral Tranexamic Acid for the Reduction of Morbidity in Hospitalized Critically Ill Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01683747
• Other study ID #: 110376
• Status: Terminated
• Phase: Phase 2
• First received: September 9, 2012
• Last updated: November 16, 2015
• Start date: June 2012
• Est. completion date: November 2014

Study information

• Verified date: November 2015
• Source: San Diego Veterans Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Data and Safety Monitoring BoardUnited States: Institutional Review BoardUnited States: VA Research & Development Committee
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness
• Hypotension
• Sepsis
• Shock

Intervention

Drug:
• Tranexamic Acid

• Control Intervention (Carrier fluid only)

Locations

Country	Name	City	State
United States	VA San Diego Health Care System	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
San Diego Veterans Healthcare System	Inflammagen/Leading Ventures

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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]	6 months	No
Secondary	mortality	All-cause death will be measured at 28 days	28 days	No
Secondary	mortality	All cause mortality will be measured at 6 months	6 months	No
Secondary	ICU length of stay	Time spent as a patient in the ICU will be measured	up to 6 months	No
Secondary	Hospital length of stay	Time spent in the hospital as a patient will be measured	up to 6 months	No