A Pilot Study Comparing Anti-Inflammatory Effects Of TXA Versus EACA In Pediatric Congenital Heart Surgery

NCT ID: NCT02656472

Last Updated: 2024-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2017-04-30

Brief Summary

The purpose of this study is to compare anti-inflammatory effects of two anti-fibrinolytic drugs (Tranexamic acid versus Epsilon-aminocaproic acid) in pediatric patients undergoing pediatric cardiac surgery.

Detailed Description

Bleeding under cardiopulmonary bypass (CPB) is one of the most common complications in patients undergoing pediatric cardiac surgery. The inflammatory response produced during and after CPB is a factor that adds significantly to the morbidity after cardiac surgery. A number of factors have been shown to be involved inducing the inflammatory response. These include complement system activation and activation of inflammatory cytokines, especially Interleukin (IL)-1, IL-6, IL-8 and Tumor necrosis factor (TNF) alpha.

Tranexamic Acid (TXA) and Epsilon-Aminocaproic Acid (EACA) are lysine analogues frequently used as anti-fibrinolytic agents in patients undergoing CPB. Many authors have highlighted the role of TXA in reducing blood loss and blood transfusion during and after CPB. Role of EACA and aprotinin in decreasing pro-inflammatory response during and after CPB has been well documented in adult literature. Patients undergoing redo sternotomy have higher inflammatory response as compared to patients undergoing first cardiac surgery. It has also been shown that the TXA can reduce the inflammatory response after CPB by acting directly or indirectly on the inflammatory cytokines.

There are no studies directly comparing the anti-inflammatory properties of EACA and TXA in the pediatric population undergoing CPB. In our institution, EACA is used as the standard of practice to reduce the blood loss during pediatric cardiac surgeries, but the investigators have now started using TXA more recently.

The aim of this study is to compare the anti-inflammatory and anti-fibrinolytic properties of these two anti-fibrinolytic agents in pediatric patients undergoing CPB for cardiac surgery.

Hypothesis: Tranexamic acid (TXA) has better anti-inflammatory profile as compared to €-Amino Caproic Acid (EACA) which may help in reducing blood loss, renal injury, hepatic injury and blood transfusion during and after CPB

Specific Objectives: During redo sternotomy procedures there is significant anti-inflammatory response which occurs and plays a role in increasing amount chest tube output, blood loss, renal injury, hepatic injury and ultimately patient morbidity and/or mortality. The proposed study will help to know if antifibrinolytic agents are beneficial in reducing the anti-inflammatory response produced and which of the two drugs (EACA or TXA), has a better anti-inflammatory profile when used in a similar setting for patients undergoing pediatric cardiothoracic surgery.

Specific Aims:

Evaluate whether TXA or EACA can decrease inflammatory response produced during redo sternotomy procedures in pediatric patients and which drug decreases the injury and/or cardiac dysfunction more as reflected by fluid balances, inotropic support, diuretic requirement, length of ventilator support, length of ICU stay, and length of hospital stay.

Conditions

Pediatric Cardiac Surgery; Complication of Extracorporeal Circulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Tranexamic Acid Arm

TXA arm will include 10 subjects who will receive TXA for duration of surgery.

Group Type: ACTIVE_COMPARATOR

Tranexamic acid

Intervention Type: DRUG

TXA Loading dose: 31 mg/kg diluted to 2 ml/kg Normal saline (NS) -in syringe

Epsilon Aminocaproic Acid Arm

EACA arm will include 10 subjects who will receive EACA for the duration of surgery.

Group Type: ACTIVE_COMPARATOR

Epsilon Aminocaproic Acid

Intervention Type: DRUG

Aminocaproic acid Loading dose: 75 mg/kg diluted to 2 ml/kg NS

Interventions

Tranexamic acid

TXA Loading dose: 31 mg/kg diluted to 2 ml/kg Normal saline (NS) -in syringe

Intervention Type: DRUG

Epsilon Aminocaproic Acid

Aminocaproic acid Loading dose: 75 mg/kg diluted to 2 ml/kg NS

Intervention Type: DRUG

Other Intervention Names

TXA; EACA

Eligibility Criteria

Inclusion Criteria

• Patients undergoing pediatric cardiac surgery, with redo sternotomy needing cardiopulmonary bypass

Exclusion Criteria

• Patients undergoing Fontan or Glenn procedures
• Allergy to EACA or TXA

• Prothrombin time (PT) >50% of High Normal value
• Partial Thromboplastin Time (PTT) > 50% of High Normal value
• Platelets < 50,000/mm3
• International normalized ratio (INR) >2
• Acute or chronic renal failure (creatinine > 2x high normal for age)
• Chronic hepatopathy (any transaminase > 2x high normal for age)
• Use of immunosuppressant drugs (within last 1 month)
• History of seizures (currently on antiepileptic drugs for epilepsy or history of seizure within last 6 months)

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew VanBergen, M.D.

Role: PRINCIPAL_INVESTIGATOR

Director, Section of Pediatric Cardiac Critical Care

Locations

Advocate Childrens Hospital

Oak Lawn, Illinois, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

K5900283

Identifier Type: -

Identifier Source: org_study_id