Efficacy of Tranexamic Acid and Epsilon-aminocaproic Acid in Reducing Bleeding and Transfusions in Cardiac Surgery

NCT02655653 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 08-08-291
• Study Type: interventional
• Target: 114
• Locations: 0 countries
• Sites: N/A

Brief Summary

The investigators primary objective is to compare the effectiveness of epsilon-aminocaproic acid (EACA) and tranexamic acid (TA) in reducing bleeding and transfusion in cardiac surgery, with the hypothesis that TA is more effective. The investigators also seek to further examine the clinical benefits and adverse effects profiles of epsilon-aminocaproic acid and tranexamic acid.

Conditions

Bleeding

Outcome Measures

Primary Outcomes (2)

• Chest Tube Drainage

  Chest tube drainage are collected from the nursing records, every 4th hourly the amount fluid collected is reported in the collection sheets.

  4 hours, 8 hours, 12 hours, 24 hours

• Median Amount of Blood Products Used

  Four types of blood products may be given through blood transfusions: whole blood, red blood cells, platelets, and plasma

  24 hours after surgery

Secondary Outcomes (7)

• Diagnosis of Renal Dysfunction Post-operation

  Within 30 days after surgery

• Diagnosis of Myocardial Infarction Post-operation

  Within 30 days after surgery

• Number of Participants Who Have Confirmed Diagnosis of Respiratory Arrest

  Within 30 days after surgery

• Number of Participants With Confirmed Diagnosis of Stroke

  Within 30 days after surgery

• Number of Participants With Confirmed Diagnosis of Seizure

  Within 30 days after surgery

Other Outcomes (3)

• Patient Demographics

  Baseline

• Type of Surgery

  Intraoperative

• Intraoperative Characteristics

  Intraoperative

Study Arms (2)

Epsilon-aminocaproic acid (EACA)

EXPERIMENTAL

Epsilon-aminocaproic acid administered following anesthetic induction: EACA was administered as a bolus loading dose of 150 mg/ kg followed by a maintenance infusion of 15 mg/ kg /hr.

Drug: Epsilon-aminocaproic acid administered

Tranexamic acid (TA)

EXPERIMENTAL

Tranexamic Acid administered following induction: TA was administered as a bolus dose of 30 mg /kg followed by a 16 mg/ kg/hour maintenance infusion.

Drug: Tranexamic Acid administered

Interventions

Epsilon-aminocaproic acid administered DRUG

Following anesthetic induction, Epsilon-aminocaproic acid was administered as a bolus loading dose of 150 mg/ kg followed by a maintenance infusion of 15 mg/ kg /hr. Maintenance infusion of both drugs was discontinued when the patient arrived in the cardiac surgical intensive care unit. In addition to routine blood sampling ( standard of care in our hospital), patients had thromboelastogram(TEG) and D-dimer levels drawn at the following time points: post incision but prior to initial antifibrinolytic load, immediately following the antifibrinolytic loading dose, and post-protamine reversal of heparin.

Epsilon-aminocaproic acid (EACA)

Tranexamic Acid administered DRUG

Following anesthetic induction, Tranexamic Acid was administered as a bolus dose of 30 mg /kg followed by a 16 mg/ kg/hour maintenance infusion. Maintenance infusion of both drugs was discontinued when the patient arrived in the cardiac surgical intensive care unit. In addition to routine blood sampling ( standard of care in our hospital), patients had thromboelastogram(TEG) and D-dimer levels drawn at the following time points: post incision but prior to initial antifibrinolytic load, immediately following the antifibrinolytic loading dose, and post-protamine reversal of heparin.

Tranexamic acid (TA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent obtained before any trial-related activities
• Subjects scheduled to undergo cardiac surgery requiring cardiopulmonary bypass

You may not qualify if:

• Vulnerable patient populations (unable to consent)
• Religious or other prohibitive reason for not receiving blood transfusion
• History of allergy to epsilon-aminocaproic acid or tranexamic acid
• Pregnant or breast-feeding (if applicable)
• The participation in another clinical or device trial that would affect the patient's coagulation profile
• Cardiac or cardiopulmonary transplantation procedure
• Any history of stroke and/or non-coronary thrombotic disorders (DVT, PE)
• Clinical signs consistent with non-coronary thrombotic disease
• Known congenital deficiency of Protein C, Protein S, Antithrombin and homozygous Factor V Leiden
• Known congenital bleeding disorders
• Weight \< 50 kg
• Weight \> 150 kg
• Acute renal failure or creatinine \> 2.0 mg/dL
• Current surgery including any implantable ventricular assist device requiring CPB including ECMO (extracorpeal membrane oxygenation)
• Current surgery including the aortic arch and/or descending thoracic aorta

Sponsors & Collaborators

• Montefiore Medical Center: lead

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Jonathan Leff
• Organization: Montefiore Medical Centr

jleff@montefiore.org

7189205409

Study Officials

• Jonathan D Leff, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Cardiothoracic Anesthesiology

Study Record Dates

• First Submitted: December 31, 2015
• First Posted: January 14, 2016
• Study Start: October 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2015
• Last Updated: June 16, 2020
• Results First Posted: June 16, 2020

Record last verified: 2020-06