Congenital Heart DiseaseNCT02352675
Determination of the Minimal Concentration of Antifibrinolytics Required to Inhibit t-PA-activated Fibrinolysis
An observational study of Congenital Heart Disease and Fibrinolysis, run by Boston Children's Hospital at 1 site in United States.
Trial summary
Lysine analogs, like tranexamic acid (TXA) or epsilon aminocaproic acid (EACA), are antifibrinolytic agents routinely administered in children undergoing different surgeries associated with a high bleeding risk (e.g. cardiac, craniofacial, and orthopedic surgeries). Read more about this study
- Who is it for?
- Ages 2 to 12 months
- Conditions the study is for
- Congenital Heart Disease, Fibrinolysis, Rotational Thromboelastometry
- What is being tested?
- Intraoperative Blood Sample
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 2 to 12 months
- All sexes
- No healthy volunteers
- Child
Study population: This is a prospective in vitro study being performed on whole blood obtained from two groups of infants. The first group will include infants with congenital heart disease (CHD) who are scheduled to undergo an elective cardiac catheterization lab procedure at Boston Children's Hospital. The second group will include infants who do not have congenital heart disease (No-CHD) and are scheduled to undergo a non-cardiac surgery (such as craniofacial surgery, neurosurgery, or orthopedic surgery) in the operating room at Boston Children's Hospital.
Who may be able to join
- infants between 2 months of age and equal to or less than 12 months of age
- weigh over 5.0 kg
- either have CHD and are scheduled to undergo an elective cardiac catheterization lab procedure or do not have CHD and are scheduled to undergo a non-cardiac surgery (such as craniofacial surgery, neurosurgery, or orthopedic surgery) in the operating room
Who cannot join
- undergoing an emergent procedure,
- child in a moribund condition (American Society of Anesthesiology (ASA 5)
- children with a hematological and/or oncological disease
- Jehovah witnesses
- children with preoperative coagulopathy, defined as a platelet count < 100,000/μL, fibrinogen level < 100 mg/dL, prothrombin time (PT) and activated partial thromboplastin time (PTT) > 1.5 normal range
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Determination of the Minimal Concentration of Antifibrinolytics Required to Inhibit t-PA-activated Fibrinolysis Using an in Vitro Experimental Model of Fibrinolysis.
Lysine analogs, like tranexamic acid (TXA) or epsilon aminocaproic acid (EACA), are antifibrinolytic agents routinely administered in children undergoing different surgeries associated with a high bleeding risk (e.g. cardiac, craniofacial, and orthopedic surgeries). Although there is a growing literature regarding the pharmacokinetic characteristics of these drugs in children, the plasmatic concentration required to completely inhibit fibrinolysis remains to be determined. In this in vitro study, the investigators will use an experimental model of fibrinolysis designed for rotational thromboelastometry (ROTEM®) to determine the minimal concentration inhibiting fibrinolysis for both TXA and EACA. In addition, this study will be used to create and validate a new experimental assay to measure fibrinolysis and the effect of antifibrinolytic agents.
- Being tested
- Intraoperative Blood Sample
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative Blood SampleOther
Blood sample will be run using rotational thromboelastometry to determine the minimal concentration of TXA and EACA need to inhibit fibrinolysis
| Study group | Role | What they receive |
|---|---|---|
| Congenital Heart Disease | Infants with congenital heart disease (CHD) who are scheduled to undergo an elective cardiac catheterization lab procedure at Boston Children's Hospital Receives: Other: Intraoperative Blood Sample | |
| Non Congenital Heart Disease | Infants who do not have congenital heart disease (No-CHD) and are scheduled to undergo a non-cardiac surgery (such as craniofacial surgery, neurosurgery, or orthopedic surgery) in the operating room at Boston Children's Hospital. Receives: Other: Intraoperative Blood Sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of antifibrinolytics associated with a complete inhibition of t-PA activated fibrinolysis confirmed by EXTEM test and the Star-TEM test.
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2015 (estimated)
- Study startApr 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Faraoni, Boston Children's Hospital
- Investigators
- David Faraoni, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02352675
- Sponsor's protocol ID
- P00016186
- Status last verified
- Jul 2017
- First submitted
- 26 Jan 2015
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Miller BE, Mochizuki T, Levy JH, Bailey JM, Tosone SR, Tam VK, Kanter KR. Predicting and treating coagulopathies after cardiopulmonary bypass in children. Anesth Analg. 1997 Dec;85(6):1196-202. doi: 10.1097/00000539-199712000-00003.
PubMed 9390579Arnold P. Treatment and monitoring of coagulation abnormalities in children undergoing heart surgery. Paediatr Anaesth. 2011 May;21(5):494-503. doi: 10.1111/j.1460-9592.2010.03461.x. Epub 2010 Dec 1.
PubMed 21118327Ngaage DL, Bland JM. Lessons from aprotinin: is the routine use and inconsistent dosing of tranexamic acid prudent? Meta-analysis of randomised and large matched observational studies. Eur J Cardiothorac Surg. 2010 Jun;37(6):1375-83. doi: 10.1016/j.ejcts.2009.11.055. Epub 2010 Feb 1.
PubMed 20117944Eaton MP. Antifibrinolytic therapy in surgery for congenital heart disease. Anesth Analg. 2008 Apr;106(4):1087-100. doi: 10.1213/ane.0b013e3181679555.
PubMed 18349177Faraoni D, Willems A, Melot C, De Hert S, Van der Linden P. Efficacy of tranexamic acid in paediatric cardiac surgery: a systematic review and meta-analysis. Eur J Cardiothorac Surg. 2012 Nov;42(5):781-6. doi: 10.1093/ejcts/ezs127. Epub 2012 Apr 24.
PubMed 22531271Faraoni D, Goobie SM. New insights about the use of tranexamic acid in children undergoing cardiac surgery: from pharmacokinetics to pharmacodynamics. Anesth Analg. 2013 Oct;117(4):760-762. doi: 10.1213/ANE.0b013e3182a22278. No abstract available.
PubMed 24057950Faraoni D. Safety of tranexamic acid in pediatric cardiac surgery: what we do not know. Eur J Cardiothorac Surg. 2011 Dec;40(6):1550-1; author reply 1551-2. doi: 10.1016/j.ejcts.2011.03.009. Epub 2011 Apr 14. No abstract available.
PubMed 21497106Raza I, Davenport R, Rourke C, Platton S, Manson J, Spoors C, Khan S, De'Ath HD, Allard S, Hart DP, Pasi KJ, Hunt BJ, Stanworth S, MacCallum PK, Brohi K. The incidence and magnitude of fibrinolytic activation in trauma patients. J Thromb Haemost. 2013 Feb;11(2):307-14. doi: 10.1111/jth.12078.
PubMed 23176206Dekker SE, Viersen VA, Duvekot A, de Jong M, van den Brom CE, van de Ven PM, Schober P, Boer C. Lysis onset time as diagnostic rotational thromboelastometry parameter for fast detection of hyperfibrinolysis. Anesthesiology. 2014 Jul;121(1):89-97. doi: 10.1097/ALN.0000000000000229.
PubMed 24646494
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Minimal Concentration of Antifibrinolytics Required to Inhibit t-PA-activated Fibrinolysis Using an in Vitro Experimental Model of Fibrinolysis.
- ClinicalTrials.gov ID
- NCT02352675
- Acronym / sponsor ID
- P00016186
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 2 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lysine analogs, like tranexamic acid (TXA) or epsilon aminocaproic acid (EACA), are antifibrinolytic agents routinely administered in children undergoing different surgeries associated with a high bleeding risk (e.g. cardiac, craniofacial, and orthopedic surgeries). Although there is a growing literature regarding the pharmacokinetic characteristics of these drugs in children, the plasmatic concentration required to completely inhibit fibrinolysis remains to be determined. In this in vitro study, the investigators will use an experimental model of fibrinolysis designed for rotational thromboelastometry (ROTEM®) to determine the minimal concentration inhibiting fibrinolysis for both TXA and EACA. In addition, this study will be used to create and validate a new experimental assay to measure fibrinolysis and the effect of antifibrinolytic agents.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Congenital Heart Disease | – | Other: Intraoperative Blood SampleInfants with congenital heart disease (CHD) who are scheduled to undergo an elective cardiac catheterization lab procedure at Boston Children's Hospital |
| Non Congenital Heart Disease | – | Other: Intraoperative Blood SampleInfants who do not have congenital heart disease (No-CHD) and are scheduled to undergo a non-cardiac surgery (such as craniofacial surgery, neurosurgery, or orthopedic surgery) in the operating room at Boston Children's Hospital. |
Who may qualify
- Ages
- 2 to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- This is a prospective in vitro study being performed on whole blood obtained from two groups of infants. The first group will include infants with congenital heart disease (CHD) who are scheduled to undergo an elective cardiac catheterization lab procedure at Boston Children's Hospital. The second group will include infants who do not have congenital heart disease (No-CHD) and are scheduled to undergo a non-cardiac surgery (such as craniofacial surgery, neurosurgery, or orthopedic surgery) in the operating room at Boston Children's Hospital.
Key inclusion criteria (3 listed)
- infants between 2 months of age and equal to or less than 12 months of age
- weigh over 5.0 kg
- either have CHD and are scheduled to undergo an elective cardiac catheterization lab procedure or do not have CHD and are scheduled to undergo a non-cardiac surgery (such as craniofacial surgery, neurosurgery, or orthopedic surgery) in the operating room
Key exclusion criteria (5 listed)
- undergoing an emergent procedure,
- child in a moribund condition (American Society of Anesthesiology (ASA 5)
- children with a hematological and/or oncological disease
- Jehovah witnesses
- children with preoperative coagulopathy, defined as a platelet count < 100,000/μL, fibrinogen level < 100 mg/dL, prothrombin time (PT) and activated partial thromboplastin time (PTT) > 1.5 normal range
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 |
|---|---|---|
| Intraoperative Blood SampleBlood sample will be run using rotational thromboelastometry to determine the minimal concentration of TXA and EACA need to inhibit fibrinolysis | Other | Congenital Heart Disease, Non Congenital Heart Disease |
Primary outcome
Concentration of antifibrinolytics associated with a complete inhibition of t-PA activated fibrinolysis confirmed by EXTEM test and the Star-TEM test.
Time frame: One Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
- Background: PubMed 9390579Miller BE, Mochizuki T, Levy JH, Bailey JM, Tosone SR, Tam VK, Kanter KR. Predicting and treating coagulopathies after cardiopulmonary bypass in children. Anesth Analg. 1997 Dec;85(6):1196-202. doi: 10.1097/00000539-199712000-00003.
- Background: PubMed 21118327Arnold P. Treatment and monitoring of coagulation abnormalities in children undergoing heart surgery. Paediatr Anaesth. 2011 May;21(5):494-503. doi: 10.1111/j.1460-9592.2010.03461.x. Epub 2010 Dec 1.
- Background: PubMed 20117944Ngaage DL, Bland JM. Lessons from aprotinin: is the routine use and inconsistent dosing of tranexamic acid prudent? Meta-analysis of randomised and large matched observational studies. Eur J Cardiothorac Surg. 2010 Jun;37(6):1375-83. doi: 10.1016/j.ejcts.2009.11.055. Epub 2010 Feb 1.
- Background: PubMed 18349177Eaton MP. Antifibrinolytic therapy in surgery for congenital heart disease. Anesth Analg. 2008 Apr;106(4):1087-100. doi: 10.1213/ane.0b013e3181679555.
- Background: PubMed 22531271Faraoni D, Willems A, Melot C, De Hert S, Van der Linden P. Efficacy of tranexamic acid in paediatric cardiac surgery: a systematic review and meta-analysis. Eur J Cardiothorac Surg. 2012 Nov;42(5):781-6. doi: 10.1093/ejcts/ezs127. Epub 2012 Apr 24.
- Background: PubMed 24057950Faraoni D, Goobie SM. New insights about the use of tranexamic acid in children undergoing cardiac surgery: from pharmacokinetics to pharmacodynamics. Anesth Analg. 2013 Oct;117(4):760-762. doi: 10.1213/ANE.0b013e3182a22278. No abstract available.
- Background: PubMed 21497106Faraoni D. Safety of tranexamic acid in pediatric cardiac surgery: what we do not know. Eur J Cardiothorac Surg. 2011 Dec;40(6):1550-1; author reply 1551-2. doi: 10.1016/j.ejcts.2011.03.009. Epub 2011 Apr 14. No abstract available.
- Background: PubMed 23176206Raza I, Davenport R, Rourke C, Platton S, Manson J, Spoors C, Khan S, De'Ath HD, Allard S, Hart DP, Pasi KJ, Hunt BJ, Stanworth S, MacCallum PK, Brohi K. The incidence and magnitude of fibrinolytic activation in trauma patients. J Thromb Haemost. 2013 Feb;11(2):307-14. doi: 10.1111/jth.12078.
- Background: PubMed 24646494Dekker SE, Viersen VA, Duvekot A, de Jong M, van den Brom CE, van de Ven PM, Schober P, Boer C. Lysis onset time as diagnostic rotational thromboelastometry parameter for fast detection of hyperfibrinolysis. Anesthesiology. 2014 Jul;121(1):89-97. doi: 10.1097/ALN.0000000000000229.
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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.
David Faraoni, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease and Fibrinolysis, run by Boston Children's Hospital 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 3 inclusion and 5 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 1 Aug 2017. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Concentration of antifibrinolytics associated with a complete inhibition of t-PA activated fibrinolysis confirmed by EXTEM test and the Star-TEM test. (time frame: One Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02352675, which also lists 9 linked publications.
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 1 Aug 2017.