Pediatric Cardiac SurgeryPhase 4TXAEACANCT02656472
A Pilot Study Comparing Anti-Inflammatory Effects Of TXA Versus EACA In Pediatric Congenital Heart Surgery
A Phase 4 study testing Tranexamic acid and Epsilon Aminocaproic Acid in people with Pediatric Cardiac Surgery and Complication of Extracorporeal Circulation, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 months to 17 years
- Conditions the study is for
- Pediatric Cardiac Surgery, Complication of Extracorporeal Circulation
- What is being tested?
- Tranexamic acid and Epsilon Aminocaproic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Apr 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients undergoing pediatric cardiac surgery, with redo sternotomy needing cardiopulmonary bypass
Who cannot join
- Patients undergoing Fontan or Glenn procedures
- Allergy to EACA or TXA
- Baseline coagulation profile abnormality * (The coagulation profile will be used as an exclusion criteria, if results available. Occasionally the results of coagulation profile may be unavailable prior to surgery due to a clotted sample. For such patients, as per the current clinical practice, we would not be redrawing the lab solely for a research purpose)
- Prothrombin time (PT) >50% of High Normal value
- Partial Thromboplastin Time (PTT) > 50% of High Normal value
- Platelets < 50,000/mm3
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Advocate Childrens Hospital
Oak Lawn, Illinois, 60453
About this study
Official title: A Pilot Study Comparing Anti-Inflammatory Effects Of Tranexamic Acid Versus Epsilon Aminocaproic Acid In Pediatric Congenital Heart Surgery
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.
Read the 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.
- Being tested
- Tranexamic acid, Epsilon Aminocaproic Acid
- Keywords
- Pediatric Cardiac surgery, Inflammatory response, Tranexamic acid, Epsilon Aminocaproic Acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acidDrug
Also called TXA
TXA Loading dose: 31 mg/kg diluted to 2 ml/kg Normal saline (NS) -in syringe
Epsilon Aminocaproic AcidDrug
Also called EACA
Aminocaproic acid Loading dose: 75 mg/kg diluted to 2 ml/kg NS
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic Acid Arm | Active comparator | TXA arm will include 10 subjects who will receive TXA for duration of surgery. Receives: Drug: Tranexamic acid |
| Epsilon Aminocaproic Acid Arm | Active comparator | EACA arm will include 10 subjects who will receive EACA for the duration of surgery. Receives: Drug: Epsilon Aminocaproic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours post-surgery
Secondary outcomes (7)
Chest Tube Output
Chest tube output in ml/kg for the first 48 hours
Measured: 48 hours post-surgery
Blood Replacement Volume
Compare the volume of blood product replacement needed in first 48 hours of surgery (including blood products used in OR)
Measured: 48 hours post-surgery
Platelet Levels
Antifibrinolytic effect using platelets levels x 1000/mL
Measured: Immediately post-surgery and 24 hours post-surgery
Liver Enzymes
Tests were recorded and compared between the groups to analyze the effect of the antifibrinolytic agent used on the amount of blood loss as well as effect of inflammation on the liver and kidney.
Measured: Immediately post-surgery and 24 hours post-surgery
Hemoglobin
Tests were recorded and compared between the groups to analyze the effect of the antifibrinolytic agent used on the amount of blood loss as well as effect of inflammation on the liver and kidney.
Measured: Immediately post-surgery and 24 hours post-surgery
Creatinine
Tests were recorded and compared between the groups to analyze the effect of the antifibrinolytic agent used on the amount of blood loss as well as effect of inflammation on the liver and kidney.
Measured: Immediately post-surgery and 24 hours post-surgery
Length of Stay
Length of stay in the ICU and overall hospital stay.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2016 (estimated)
- Study startFeb 2016
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pediatric Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew VanBergen, M.D., Principal investigator, Director, Section of Pediatric Cardiac Critical Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02656472
- Sponsor's protocol ID
- K5900283
- Acronym
- TXAEACA
- Status last verified
- Oct 2024
- First submitted
- 29 Dec 2015
- Last updated
- 24 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Comparing Anti-Inflammatory Effects Of Tranexamic Acid Versus Epsilon Aminocaproic Acid In Pediatric Congenital Heart Surgery
- ClinicalTrials.gov ID
- NCT02656472
- Acronym / sponsor ID
- TXAEACA / K5900283
- Keywords
- Pediatric Cardiac surgery, Inflammatory response, Tranexamic acid, Epsilon Aminocaproic Acid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 15 Jan 2016 (estimated)
- Results
- Posted 22 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic Acid Arm | Active comparator | Drug: Tranexamic acidTXA arm will include 10 subjects who will receive TXA for duration of surgery. |
| Epsilon Aminocaproic Acid Arm | Active comparator | Drug: Epsilon Aminocaproic AcidEACA arm will include 10 subjects who will receive EACA for the duration of surgery. |
Who may qualify
- Ages
- 3 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients undergoing pediatric cardiac surgery, with redo sternotomy needing cardiopulmonary bypass
Key exclusion criteria (11 listed)
- Patients undergoing Fontan or Glenn procedures
- Allergy to EACA or TXA
- Baseline coagulation profile abnormality * (The coagulation profile will be used as an exclusion criteria, if results available. Occasionally the results of coagulation profile may be unavailable prior to surgery due to a clotted sample. For such patients, as per the current clinical practice, we would not be redrawing the lab solely for a research purpose)
- Acute or chronic renal failure (creatinine > 2x high normal for age)
- Chronic hepatopathy (any transaminase > 2x high normal for age)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic acidAlso: TXATXA Loading dose: 31 mg/kg diluted to 2 ml/kg Normal saline (NS) -in syringe | Drug | Tranexamic Acid Arm |
| Epsilon Aminocaproic AcidAlso: EACAAminocaproic acid Loading dose: 75 mg/kg diluted to 2 ml/kg NS | Drug | Epsilon Aminocaproic Acid Arm |
Primary outcome
Inflammatory Markers/Cytokines
Time frame: 24 hours post-surgery
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.
7 secondary outcomes
Chest Tube Output
Time frame: 48 hours post-surgery
Blood Replacement Volume
Time frame: 48 hours post-surgery
Platelet Levels
Time frame: Immediately post-surgery and 24 hours post-surgery
Liver Enzymes
Time frame: Immediately post-surgery and 24 hours post-surgery
Hemoglobin
Time frame: Immediately post-surgery and 24 hours post-surgery
Creatinine
Time frame: Immediately post-surgery and 24 hours post-surgery
Length of Stay
Time frame: 2 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew VanBergen, M.D. principal investigator
Director, Section of Pediatric Cardiac Critical Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tranexamic acid and Epsilon Aminocaproic Acid in people with Pediatric Cardiac Surgery and Complication of Extracorporeal Circulation, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammatory Markers/Cytokines (time frame: 24 hours post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2024.