Congenital Heart DiseaseNCT03214120
Does Modified Ultrafiltration Affect Thromboelastography Results?
An observational study of Congenital Heart Disease, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 1 month
- Conditions the study is for
- Congenital Heart Disease
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2018to 1 Jan 2019
- How long will I take part?
- 2 Days
- 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 1 day to 1 month
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- congenital heart disease
- pediatric cardiac operation with cardiopulmonary bypass
- modified ultrafiltration done at the end of cardiopulmonary bypass
Who cannot join
- Cardiopulmonary bypass is not used
- Modified ultrafiltration is not performed
Trial locations and contacts
1 site in 1 country.
United States1 site
Advocate Children's Hospital
Oak Lawn, Illinois, 60453
About this study
The study is to evaluate the effect of modified ultrafiltration on different components of Thromboelastography (TEG) in neonates undergoing cardiac surgery using cardiopulmonary bypass.
Read the detailed description
The study will be performed at Advocate Children's Hospital, Oak Lawn. All neonates undergoing cardiac operations with cardiopulmonary bypass and modified ultrafiltration will be enrolled. Parents will be consented before surgery.
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
- Congenital Heart Disease
- Keywords
- thromboelastography, modified ultrafiltration
- Medical subject headings
- Heart Defects, Congenital
What is being measured
The primary outcome is the main question the study is designed to answer.
change in thromboelastography components after modified ultrafiltration
effect of modified ultrafiltration on different components of thromboelastography
Measured: 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
use of packed red cells, fresh frozen plasma and platelets during or after surgery
Measured: initial phase of recovery (2 days) in the intensive care unit after cardiac surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start8 Jan 2018
- Primary completion1 Jan 2019
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- 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
- 40 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chawki Elzein, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03214120
- Sponsor's protocol ID
- K5900405
- Status last verified
- Oct 2024
- First submitted
- 4 Jul 2017
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 7505562Luciani 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.
PubMed 11568065Kane 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.
PubMed 26237992Niebler 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.
PubMed 23804904Williams 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.
PubMed 10468251Chew 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.
PubMed 11388523Paparella 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.
PubMed 11825729Bando 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.
PubMed 9535437Huang 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.
PubMed 12842527Forman 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.
PubMed 24522100
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Modified Ultrafiltration Affect Thromboelastography Results?
- ClinicalTrials.gov ID
- NCT03214120
- Acronym / sponsor ID
- K5900405
- Conditions
- Congenital Heart Disease
- Keywords
- thromboelastography, modified ultrafiltration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 11 Jul 2017 (actual)
- 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.
The study is to evaluate the effect of modified ultrafiltration on different components of Thromboelastography (TEG) in neonates undergoing cardiac surgery using cardiopulmonary bypass.
Detailed description
The study will be performed at Advocate Children's Hospital, Oak Lawn. All neonates undergoing cardiac operations with cardiopulmonary bypass and modified ultrafiltration will be enrolled. Parents will be consented before surgery.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Days
Who may qualify
- Ages
- 1 day to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- congenital heart disease
- pediatric cardiac operation with cardiopulmonary bypass
- modified ultrafiltration done at the end of cardiopulmonary bypass
Key exclusion criteria (2 listed)
- Cardiopulmonary bypass is not used
- Modified ultrafiltration is not performed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
change in thromboelastography components after modified ultrafiltration
Time frame: 1 hour (time during surgery after doing modified ultrafiltration) to 2 days (postoperative recovery in intensive care unit)
effect of modified ultrafiltration on different components of thromboelastography
1 secondary outcome
blood products utilization during and after surgery
Time frame: initial phase of recovery (2 days) in the intensive care unit after cardiac surgery
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 4 Oct 2024.
- Results publication: PubMed 7505562Moat 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.
- Results publication: PubMed 11568065Luciani 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.
- Results publication: PubMed 26237992Kane 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.
- Results publication: PubMed 23804904Niebler 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.
- Results publication: PubMed 10468251Williams 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.
- Results publication: PubMed 11388523Chew 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.
- Results publication: PubMed 11825729Paparella 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.
- Results publication: PubMed 9535437Bando 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.
- Results publication: PubMed 12842527Huang 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.
- Results publication: PubMed 24522100Forman 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.
- Individual participant dataSharing planned: No
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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.
Chawki Elzein, MD principal investigator
Wake Forest University Health Sciences
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 Wake Forest University Health Sciences 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: finished, as of the sponsor's last update on 4 Oct 2024. 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?
change in thromboelastography components after modified ultrafiltration (time frame: 1 hour (time during surgery after doing modified ultrafiltration) to 2 days (postoperative recovery in intensive care unit)). 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 NCT03214120, which also lists 10 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 4 Oct 2024; AzTrials last refreshed its copy on 28 Oct 2026.