Does Modified Ultrafiltration Affect Thromboelastography Results?

NCT03214120 | Completed DMC

• 1 other identifier: K5900405
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The study is to evaluate the effect of modified ultrafiltration on different components of Thromboelastography (TEG) in neonates undergoing cardiac surgery using cardiopulmonary bypass.

Conditions

Congenital Heart Disease

Keywords

thromboelastography, modified ultrafiltration

Outcome Measures

Primary Outcomes (1)

• change in thromboelastography components after modified ultrafiltration

  effect of modified ultrafiltration on different components of thromboelastography

  1 hour (time during surgery after doing modified ultrafiltration) to 2 days (postoperative recovery in intensive care unit)

Secondary Outcomes (1)

• blood products utilization during and after surgery

  initial phase of recovery (2 days) in the intensive care unit after cardiac surgery

Eligibility Criteria

• Age: 1 Day - 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Neonates with congenital heart disease requiring cardiac surgery during the first month of life, with the use of cardiopulmonary bypass and modified ultrafiltration.

You may qualify if:

• congenital heart disease
• pediatric cardiac operation with cardiopulmonary bypass
• modified ultrafiltration done at the end of cardiopulmonary bypass

You may not qualify if:

• Cardiopulmonary bypass is not used
• Modified ultrafiltration is not performed

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Advocate Children's Hospital

Oak Lawn, Illinois, 60453, United States

Location

Related Publications (10)

• Moat NE, Rebuck N, Shore DF, Evans TW, Finn AH. Humoral and cellular activation in a simulated extracorporeal circuit. Ann Thorac Surg. 1993 Dec;56(6):1509-14. doi: 10.1016/0003-4975(93)90742-z.

  PMID: 7505562 RESULT

• Luciani GB, Menon T, Vecchi B, Auriemma S, Mazzucco A. Modified ultrafiltration reduces morbidity after adult cardiac operations: a prospective, randomized clinical trial. Circulation. 2001 Sep 18;104(12 Suppl 1):I253-9. doi: 10.1161/hc37t1.094931.

  PMID: 11568065 RESULT

• Kane LC, Woodward CS, Husain SA, Frei-Jones MJ. Thromboelastography--does it impact blood component transfusion in pediatric heart surgery? J Surg Res. 2016 Jan;200(1):21-7. doi: 10.1016/j.jss.2015.07.011. Epub 2015 Jul 10.

  PMID: 26237992 RESULT

• Niebler RA, Gill JC, Brabant CP, Mitchell ME, Nugent M, Simpson P, Tweddell JS, Ghanayem NS. Thromboelastography in the assessment of bleeding following surgery for congenital heart disease. World J Pediatr Congenit Heart Surg. 2012 Oct 1;3(4):433-8. doi: 10.1177/2150135112447540.

  PMID: 23804904 RESULT

• Williams GD, Bratton SL, Riley EC, Ramamoorthy C. Coagulation tests during cardiopulmonary bypass correlate with blood loss in children undergoing cardiac surgery. J Cardiothorac Vasc Anesth. 1999 Aug;13(4):398-404. doi: 10.1016/s1053-0770(99)90210-0.

  PMID: 10468251 RESULT

• Chew MS, Brandslund I, Brix-Christensen V, Ravn HB, Hjortdal VE, Pedersen J, Hjortdal K, Hansen OK, Tonnesen E. Tissue injury and the inflammatory response to pediatric cardiac surgery with cardiopulmonary bypass: a descriptive study. Anesthesiology. 2001 May;94(5):745-53; discussion 5A. doi: 10.1097/00000542-200105000-00010.

  PMID: 11388523 RESULT

• Paparella D, Yau TM, Young E. Cardiopulmonary bypass induced inflammation: pathophysiology and treatment. An update. Eur J Cardiothorac Surg. 2002 Feb;21(2):232-44. doi: 10.1016/s1010-7940(01)01099-5.

  PMID: 11825729 RESULT

• Bando K, Vijay P, Turrentine MW, Sharp TG, Means LJ, Ensing GJ, Lalone BJ, Sekine Y, Szekely L, Brown JW. Dilutional and modified ultrafiltration reduces pulmonary hypertension after operations for congenital heart disease: a prospective randomized study. J Thorac Cardiovasc Surg. 1998 Mar;115(3):517-25; discussion 525-7. doi: 10.1016/S0022-5223(98)70313-7.

  PMID: 9535437 RESULT

• Huang H, Yao T, Wang W, Zhu D, Zhang W, Chen H, Fu W. Continuous ultrafiltration attenuates the pulmonary injury that follows open heart surgery with cardiopulmonary bypass. Ann Thorac Surg. 2003 Jul;76(1):136-40. doi: 10.1016/s0003-4975(03)00264-9.

  PMID: 12842527 RESULT

• Forman KR, Wong E, Gallagher M, McCarter R, Luban NL, Massaro AN. Effect of temperature on thromboelastography and implications for clinical use in newborns undergoing therapeutic hypothermia. Pediatr Res. 2014 May;75(5):663-9. doi: 10.1038/pr.2014.19. Epub 2014 Feb 12.

  PMID: 24522100 RESULT

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Chawki Elzein, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2017
• First Posted: July 11, 2017
• Study Start: January 8, 2018
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: October 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)