Congenital Heart DiseaseNCT02352662
Peri-operative Assessment of Coagulopathy in Neonates and Infants Undergoing Cardiac Surgery
An observational study of Congenital Heart Disease, run by Boston Children's Hospital at 1 site in United States.
Trial summary
This prospective study will aim to globally assess the coagulopathy induced during cardiac surgery with cardiopulmonary bypass (CPB) in a large pediatric population. The investigators primary objective will be the understanding of CPB-induced coagulopathy based on demographic and surgical characteristics, and… Read more about this study
- Who is it for?
- Ages Up to 12 months
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Perioperative blood samples collection
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Apr 2017
- 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 Up to 12 months
- All sexes
- No healthy volunteers
- Child
Study population: Neonates and infants undergoing cardiac surgery with cardiopulmonary bypass
Who may be able to join
- Neonates weighing greater than 2.5 kg
- Patients equal to or less than 12 months of age
- Undergoing elective cardiac surgery with cardiopulmonary bypass
Who cannot join
- Emergent procedure
- The patient is deemed to be in a moribund condition (American Society of Anesthesiology (ASA 5))
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
This prospective study will aim to globally assess the coagulopathy induced during cardiac surgery with cardiopulmonary bypass (CPB) in a large pediatric population. The investigators primary objective will be the understanding of CPB-induced coagulopathy based on demographic and surgical characteristics, and coagulation assays. Secondary objective will aim at determining the relationship between coagulation assays, postoperative blood loss, and transfusion requirements. The ultimate goal will be to design an algorithm using point-of-care monitoring that could be used to guide hemostatic therapies in neonates and children undergoing cardiac surgery.To do this, investigators will examine the coagulation in the laboratory based setting.
- Conditions
- Congenital Heart Disease
- Being tested
- Perioperative blood samples collection
- Keywords
- Congenital Heart Disease, Point-of-care coagulation monitoring, Rotaional Thromboelastometry
- 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.
Perioperative blood samples collectionOther
Collect blood samples at 3 different points intra-operatively. Each blood sample will be run using rotational thromboelastometry to assess intraoperative coagulation
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Three blood samples will be collected intra-operatively from each subject enrolled Receives: Other: Perioperative blood samples collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of CPB-induced coagulopathy confirmed by coagulation assays
Measured: Over 6 months
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 completionApr 2017
- Study completionApr 2017
Why it stopped: Competition with another study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 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
- NCT02352662
- Sponsor's protocol ID
- IRB-P00016002
- Status last verified
- Apr 2017
- First submitted
- 26 Jan 2015
- Last updated
- 10 Apr 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 9390579Faraoni D, Willems A, Romlin BS, Belisle S, Van der Linden P. Development of a specific algorithm to guide haemostatic therapy in children undergoing cardiac surgery: a single-centre retrospective study. Eur J Anaesthesiol. 2015 May;32(5):320-9. doi: 10.1097/EJA.0000000000000179.
PubMed 25387300Paparella D, Brister SJ, Buchanan MR. Coagulation disorders of cardiopulmonary bypass: a review. Intensive Care Med. 2004 Oct;30(10):1873-81. doi: 10.1007/s00134-004-2388-0. Epub 2004 Jul 24.
PubMed 15278267Arnold 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 21118327Osthaus WA, Boethig D, Johanning K, Rahe-Meyer N, Theilmeier G, Breymann T, Suempelmann R. Whole blood coagulation measured by modified thrombelastography (ROTEM) is impaired in infants with congenital heart diseases. Blood Coagul Fibrinolysis. 2008 Apr;19(3):220-5. doi: 10.1097/MBC.0b013e3282f54532.
PubMed 18388502Faraoni D, Savan V, Levy JH, Theusinger OM. Goal-directed coagulation management in the perioperative period of cardiac surgery. J Cardiothorac Vasc Anesth. 2013 Dec;27(6):1347-54. doi: 10.1053/j.jvca.2013.08.005. Epub 2013 Oct 5. No abstract available.
PubMed 24103717Gorlinger K, Dirkmann D, Hanke AA, Kamler M, Kottenberg E, Thielmann M, Jakob H, Peters J. First-line therapy with coagulation factor concentrates combined with point-of-care coagulation testing is associated with decreased allogeneic blood transfusion in cardiovascular surgery: a retrospective, single-center cohort study. Anesthesiology. 2011 Dec;115(6):1179-91. doi: 10.1097/ALN.0b013e31823497dd.
PubMed 21970887Williams GD, Bratton SL, Ramamoorthy C. Factors associated with blood loss and blood product transfusions: a multivariate analysis in children after open-heart surgery. Anesth Analg. 1999 Jul;89(1):57-64. doi: 10.1097/00000539-199907000-00011.
PubMed 10389779Hayashi T, Sakurai Y, Fukuda K, Yada K, Ogiwara K, Matsumoto T, Yoshizawa H, Takahashi Y, Yoshikawa Y, Hayata Y, Taniguchi S, Shima M. Correlations between global clotting function tests, duration of operation, and postoperative chest tube drainage in pediatric cardiac surgery. Paediatr Anaesth. 2011 Aug;21(8):865-71. doi: 10.1111/j.1460-9592.2011.03524.x. Epub 2011 Jan 21.
PubMed 21251146Jensen AS, Johansson PI, Bochsen L, Idorn L, Sorensen KE, Thilen U, Nagy E, Furenas E, Sondergaard L. Fibrinogen function is impaired in whole blood from patients with cyanotic congenital heart disease. Int J Cardiol. 2013 Sep 1;167(5):2210-4. doi: 10.1016/j.ijcard.2012.06.019. Epub 2012 Jun 22.
PubMed 22727966Faraoni D, Willems A, Savan V, Demanet H, De Ville A, Van der Linden P. Plasma fibrinogen concentration is correlated with postoperative blood loss in children undergoing cardiac surgery. A retrospective review. Eur J Anaesthesiol. 2014 Jun;31(6):317-26. doi: 10.1097/EJA.0000000000000043.
PubMed 24503704Faraoni D, Van der Linden P. Factors affecting postoperative blood loss in children undergoing cardiac surgery. J Cardiothorac Surg. 2014 Feb 11;9:32. doi: 10.1186/1749-8090-9-32.
PubMed 24512988Lacroix J, Hebert PC, Hutchison JS, Hume HA, Tucci M, Ducruet T, Gauvin F, Collet JP, Toledano BJ, Robillard P, Joffe A, Biarent D, Meert K, Peters MJ; TRIPICU Investigators; Canadian Critical Care Trials Group; Pediatric Acute Lung Injury and Sepsis Investigators Network. Transfusion strategies for patients in pediatric intensive care units. N Engl J Med. 2007 Apr 19;356(16):1609-19. doi: 10.1056/NEJMoa066240.
PubMed 17442904
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-operative Assessment of Coagulopathy in Neonates and Infants Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02352662
- Acronym / sponsor ID
- IRB-P00016002
- Conditions
- Congenital Heart Disease
- Keywords
- Congenital Heart Disease, Point-of-care coagulation monitoring, Rotaional Thromboelastometry
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Competition with another study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (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.
This prospective study will aim to globally assess the coagulopathy induced during cardiac surgery with cardiopulmonary bypass (CPB) in a large pediatric population. The investigators primary objective will be the understanding of CPB-induced coagulopathy based on demographic and surgical characteristics, and coagulation assays. Secondary objective will aim at determining the relationship between coagulation assays, postoperative blood loss, and transfusion requirements. The ultimate goal will be to design an algorithm using point-of-care monitoring that could be used to guide hemostatic therapies in neonates and children undergoing cardiac surgery.To do this, investigators will examine the coagulation in the laboratory based setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Other: Perioperative blood samples collectionThree blood samples will be collected intra-operatively from each subject enrolled |
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Neonates and infants undergoing cardiac surgery with cardiopulmonary bypass
Key inclusion criteria (3 listed)
- Neonates weighing greater than 2.5 kg
- Patients equal to or less than 12 months of age
- Undergoing elective cardiac surgery with cardiopulmonary bypass
Key exclusion criteria (2 listed)
- Emergent procedure
- The patient is deemed to be in a moribund condition (American Society of Anesthesiology (ASA 5))
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 |
|---|---|---|
| Perioperative blood samples collectionCollect blood samples at 3 different points intra-operatively. Each blood sample will be run using rotational thromboelastometry to assess intraoperative coagulation | Other | Study Group |
Primary outcome
Evidence of CPB-induced coagulopathy confirmed by coagulation assays
Time frame: Over 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 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 25387300Faraoni D, Willems A, Romlin BS, Belisle S, Van der Linden P. Development of a specific algorithm to guide haemostatic therapy in children undergoing cardiac surgery: a single-centre retrospective study. Eur J Anaesthesiol. 2015 May;32(5):320-9. doi: 10.1097/EJA.0000000000000179.
- Background: PubMed 15278267Paparella D, Brister SJ, Buchanan MR. Coagulation disorders of cardiopulmonary bypass: a review. Intensive Care Med. 2004 Oct;30(10):1873-81. doi: 10.1007/s00134-004-2388-0. Epub 2004 Jul 24.
- 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 18388502Osthaus WA, Boethig D, Johanning K, Rahe-Meyer N, Theilmeier G, Breymann T, Suempelmann R. Whole blood coagulation measured by modified thrombelastography (ROTEM) is impaired in infants with congenital heart diseases. Blood Coagul Fibrinolysis. 2008 Apr;19(3):220-5. doi: 10.1097/MBC.0b013e3282f54532.
- Background: PubMed 24103717Faraoni D, Savan V, Levy JH, Theusinger OM. Goal-directed coagulation management in the perioperative period of cardiac surgery. J Cardiothorac Vasc Anesth. 2013 Dec;27(6):1347-54. doi: 10.1053/j.jvca.2013.08.005. Epub 2013 Oct 5. No abstract available.
- Background: PubMed 21970887Gorlinger K, Dirkmann D, Hanke AA, Kamler M, Kottenberg E, Thielmann M, Jakob H, Peters J. First-line therapy with coagulation factor concentrates combined with point-of-care coagulation testing is associated with decreased allogeneic blood transfusion in cardiovascular surgery: a retrospective, single-center cohort study. Anesthesiology. 2011 Dec;115(6):1179-91. doi: 10.1097/ALN.0b013e31823497dd.
- Background: PubMed 10389779Williams GD, Bratton SL, Ramamoorthy C. Factors associated with blood loss and blood product transfusions: a multivariate analysis in children after open-heart surgery. Anesth Analg. 1999 Jul;89(1):57-64. doi: 10.1097/00000539-199907000-00011.
- Background: PubMed 21251146Hayashi T, Sakurai Y, Fukuda K, Yada K, Ogiwara K, Matsumoto T, Yoshizawa H, Takahashi Y, Yoshikawa Y, Hayata Y, Taniguchi S, Shima M. Correlations between global clotting function tests, duration of operation, and postoperative chest tube drainage in pediatric cardiac surgery. Paediatr Anaesth. 2011 Aug;21(8):865-71. doi: 10.1111/j.1460-9592.2011.03524.x. Epub 2011 Jan 21.
- Background: PubMed 22727966Jensen AS, Johansson PI, Bochsen L, Idorn L, Sorensen KE, Thilen U, Nagy E, Furenas E, Sondergaard L. Fibrinogen function is impaired in whole blood from patients with cyanotic congenital heart disease. Int J Cardiol. 2013 Sep 1;167(5):2210-4. doi: 10.1016/j.ijcard.2012.06.019. Epub 2012 Jun 22.
- Background: PubMed 24503704Faraoni D, Willems A, Savan V, Demanet H, De Ville A, Van der Linden P. Plasma fibrinogen concentration is correlated with postoperative blood loss in children undergoing cardiac surgery. A retrospective review. Eur J Anaesthesiol. 2014 Jun;31(6):317-26. doi: 10.1097/EJA.0000000000000043.
- Background: PubMed 24512988Faraoni D, Van der Linden P. Factors affecting postoperative blood loss in children undergoing cardiac surgery. J Cardiothorac Surg. 2014 Feb 11;9:32. doi: 10.1186/1749-8090-9-32.
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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, 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 2 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: withdrawn, as of the sponsor's last update on 10 Apr 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 was withdrawn before enrolling participants, so there are no results.
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?
Evidence of CPB-induced coagulopathy confirmed by coagulation assays (time frame: Over 6 months). 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 NCT02352662, which also lists 13 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 10 Apr 2017.