Effect of Tranexamic Acid in Upper Gastrointestinal Bleeding

NCT01005147 | Withdrawn DMC

• 1 other identifier: 14456
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The investigators hypothesize that addition of Tranexamic acid, an antifibrinolytic agent, to conventional therapy will lead to an improved outcome characterized by lower transfusion requirements.

Conditions

Gastrointestinal Hemorrhage

Keywords

tranexamic acid; upper GI bleeding; blood transfusion; GI bleeding

Outcome Measures

Primary Outcomes (1)

• Amount of blood transfusions needed (units of packed RBCs)

  Every 6 months

Secondary Outcomes (4)

• Rebleeding events

  Every 6 months

• Need for surgical intervention

  Every 6 months

• Mortality rates

  Every 6 months

• Length of stay in ICU

  Every 6 months

Study Arms (2)

Tranexamic acid arm

EXPERIMENTAL

Drug: tranexamic acid

Control arm

PLACEBO COMPARATOR

Will receive a placebo in place of tranexamic acid treatment

Other: Placebo

Interventions

tranexamic acid DRUG

1 gm every 6 hours for 4 days via IV for non-renal impaired subjects. Alternate IV dosing for renally-impaired subjects: 10mg/Kg BID (1.36 - 2.83 mg/dl clearance); 10mg/Kg QD (2.84 - 5.66 mg/dl clearance; and 10mg/Kg Q48H or 5mg/Kg (.5.66mg/dl clearance)

Also known as: Cyklokapron

Tranexamic acid arm

Placebo OTHER

Will receive placebo treatment as per the tranexamic acid schedule

Control arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients with GI bleed if the following criteria are met:
• has received 4 units of PRBCs within a 24-hour period, or
• has orthostatic hypotension (drop in SBP of 20mmHg or drop in DBP of 10mmHg after fluid resuscitation with at least 20ml/Kg of either isotonic fluid and/or PRBCs), or
• if the MAP remains below 60mmHg after fluid resuscitation, and
• written informed consent is obtained from the subject or legally authorized representative.

You may not qualify if:

• Pregnant or lactating women
• Known to have gastrointestinal malignancy
• On anticoagulation therapy
• Patients with history of thromboembolism
• Patients with history of myocardial infarction or ischemic cerebrovascular accident
• Patient with end stage renal disease
• Patients with DNR status
• Incarcerated individuals

Sponsors & Collaborators

• University of Oklahoma: lead

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Jijo John, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

• Gary T. Kinasewitz, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 28, 2009
• First Posted: October 30, 2009
• Study Start: November 1, 2009
• Study Completion: October 1, 2011
• Last Updated: April 9, 2012

Record last verified: 2012-04