Single Dose Enteral Tranexamic Acid in Critically Ill Patients

San Diego Veterans Healthcare System

Status and phase: Terminated; Phase 2

Conditions: Hypotension; Shock; Critical Illness; Sepsis

Treatments: Drug: Tranexamic Acid; Drug: Control Intervention (Carrier fluid only)

Study type: Interventional

Funder types: Other U.S. Federal agency; Other

Identifiers

NCT01683747

110376

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

4 participants in 2 patient groups, including a placebo group

Tranexamic acid

Experimental group

Description:

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

Treatment:

Drug: Tranexamic Acid

Control group

Placebo Comparator group

Description:

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

Treatment:

Drug: Control Intervention (Carrier fluid only)