Peri-operative Assessment of Coagulopathy in Neonates and Infants Undergoing Cardiac Surgery

Congenital Heart Disease Clinical Trial

Official title:

Peri-operative Assessment of Coagulopathy in Neonates and Infants Undergoing Cardiac Surgery

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02352662
• Other study ID #: IRB-P00016002
• Status: Withdrawn
• Phase: N/A
• First received: January 26, 2015
• Last updated: April 7, 2017
• Start date: April 2015
• Est. completion date: April 2017

Study information

• Verified date: April 2017
• Source: Boston Children’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 12 Months

Eligibility

Inclusion Criteria:

• Neonates weighing greater than 2.5 kg

• Patients equal to or less than 12 months of age

• Undergoing elective cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

• Emergent procedure

• The patient is deemed to be in a moribund condition (American Society of Anesthesiology (ASA 5))

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases
• Hemostatic Disorders

Intervention

Other:
• Perioperative blood samples collection
Collect blood samples at 3 different points intra-operatively. Each blood sample will be run using rotational thromboelastometry to assess intraoperative coagulation

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children’s Hospital

Country where clinical trial is conducted

United States, 

References & Publications (13)

Arnold 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. Review. — View Citation

Faraoni 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. Review. — View Citation

Faraoni 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. — View Citation

Faraoni 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. — View Citation

Faraoni 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. — View Citation

Görlinger 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. — View Citation

Hayashi 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. — View Citation

Jensen AS, Johansson PI, Bochsen L, Idorn L, Sørensen KE, Thilén U, Nagy E, Furenäs E, Søndergaard 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. — View Citation

Lacroix J, Hébert 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. — View Citation

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. — View Citation

Osthaus 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. — View Citation

Paparella D, Brister SJ, Buchanan MR. Coagulation disorders of cardiopulmonary bypass: a review. Intensive Care Med. 2004 Oct;30(10):1873-81. Epub 2004 Jul 24. Review. — View Citation

Williams 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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence of CPB-induced coagulopathy confirmed by coagulation assays		Over 6 months