Does Modified Ultrafiltration Affect Thromboelastography Results?
NCT ID: NCT03214120
Last Updated: 2024-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
40 participants
OBSERVATIONAL
2018-01-08
2019-01-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Is Neutrophil to Lymphocyte Ratio a Prognostic Factor of Sepsis in Newborns With Operated Neural Tube Defects?
NCT04135274
Utility of Placental/Umbilical Cord Blood in Early Onset Neonatal Sepsis in Very Low Birth Weight Infants
NCT03694613
Targeting Normoxia in Neonates With Cyanotic Congenital Heart Disease in the Intra-operative and Immediate Post-operative Period
NCT04452188
Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass
NCT01579513
Impact of Thrombocytopenia and Platelet Transfusions on Neonatal Bleeding and Inflammation
NCT03848923
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
After weaning from cardiopulmonary bypass and before starting modified ultrafiltration, a TEG sample will be taken. The components studied are Reaction time (R), Coagulation time (K), Angle, Maximum Amplitude (MA) and whole blood clot lysis index at 30 minutes (LY30). Another TEG sample will be taken after finishing modified ultrafiltration and before protamine is given. The different components will be compared pre and after modified ultrafiltration. The Primary end points are the changes of the different TEG components after modified ultrafiltration. The secondary end points are the utilization of different blood products (packed red cells, fresh frozen plasma and platelets transfusion) during and after surgery.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* pediatric cardiac operation with cardiopulmonary bypass
* modified ultrafiltration done at the end of cardiopulmonary bypass
Exclusion Criteria
* Modified ultrafiltration is not performed
1 Day
1 Month
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Wake Forest University Health Sciences
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Chawki Elzein, MD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Advocate Children's Hospital
Oak Lawn, Illinois, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
K5900405
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.