NCT02656472

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 29, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 15, 2016

Completed
17 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
7.6 years until next milestone

Results Posted

Study results publicly available

October 22, 2024

Completed
Last Updated

October 24, 2024

Status Verified

October 1, 2024

Enrollment Period

1.2 years

First QC Date

December 29, 2015

Results QC Date

July 14, 2019

Last Update Submit

October 22, 2024

Conditions

Pediatric Cardiac SurgeryComplication of Extracorporeal Circulation

Keywords

Pediatric Cardiac surgeryInflammatory responseTranexamic acidEpsilon Aminocaproic Acid

Outcome Measures

Primary Outcomes (1)

  • Inflammatory Markers/Cytokines

    Consented patients had research-related blood draws (0.3 ml) at three time points: pre-CPB, post-CBP following protamine administration and 24 hours post-CPB. Average of the values run in duplicate was used for calculations. For samples with values reported as out of range (due to level being below detection), the lowest detectable value was assigned for analysis.

    24 hours post-surgery

Secondary Outcomes (7)

  • Chest Tube Output

    48 hours post-surgery

  • Blood Replacement Volume

    48 hours post-surgery

  • Platelet Levels

    Immediately post-surgery and 24 hours post-surgery

  • Liver Enzymes

    Immediately post-surgery and 24 hours post-surgery

  • Hemoglobin

    Immediately post-surgery and 24 hours post-surgery

  • +2 more secondary outcomes

Study Arms (2)

Tranexamic Acid Arm

ACTIVE COMPARATOR

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

Drug: Tranexamic acid

Epsilon Aminocaproic Acid Arm

ACTIVE COMPARATOR

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

Drug: Epsilon Aminocaproic Acid

Interventions

Tranexamic acidDRUG

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

Also known as: TXA
Tranexamic Acid Arm
Epsilon Aminocaproic AcidDRUG

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

Also known as: EACA
Epsilon Aminocaproic Acid Arm

Eligibility Criteria

Age3 Months - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Advocate Childrens Hospital

Oak Lawn, Illinois, 60453, United States

Location

MeSH Terms

Interventions

Tranexamic AcidAminocaproic Acid

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsAminocaproatesCaproatesAcids, AcyclicAmino AcidsAmino Acids, Peptides, and Proteins

Limitations and Caveats

Small sample size and wide age range lead to substantial variation in values, making it difficult to draw conclusions. Biomarker levels were collected at three time points, not including a 4-hour post-CPB level, when most cytokines are known to peak.

Results Point of Contact

Title
Andrew VanBergen
Organization
Advocate Children's Hospital
andrew.vanbergen@advocatehealth.com
7086848758

Study Officials

  • Andrew VanBergen, M.D.

    Director, Section of Pediatric Cardiac Critical Care

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 29, 2015

First Posted

January 15, 2016

Study Start

February 1, 2016

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

October 24, 2024

Results First Posted

October 22, 2024

Record last verified: 2024-10

Locations

US(1)