Albumin vs. Plasma for PEdiAtric pRiming Trial
APPEAR
1 other identifier
interventional
80
1 country
1
Brief Summary
This is a randomized controlled trial that compares two different priming composition (albumin vs. fresh frozen plasma) for extracorporeal circulation of pediatric patients under 10 kg of weight. The two approaches are both employed at the moment but there is actually no evidence on the superiority of one over the other. This study is aimed to test the hypothesis that Albumin is superior to fresh frozen plasma in terms of minor bleeding and transfusional requirements.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 15, 2016
CompletedFirst Posted
Study publicly available on registry
April 14, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedAugust 30, 2016
August 1, 2016
1.3 years
March 15, 2016
August 29, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Volume of postoperative bleeding
Postoperative bleeding in ml/kg, as measured by chest drainage
24 hours
Secondary Outcomes (4)
Number of units of blood components transfused
48 hours
Hours on artificial ventilation
hours until extubation, an average of 72 hours
Days of hospital stay
days until discharge, an average of 10 days
Thromboembolic complications
Postoperative hospital stay until discharge, an average of 10 days
Study Arms (2)
Albumin
ACTIVE COMPARATOR5% Albumin to be added to the priming solution composed of concentrated red cells to reach a target of 28-30% hematocrit and albumin to reach the standard volume administered to these patients (400 ml)
Fresh Frozen Plasma
ACTIVE COMPARATORFresh Frozen Plasma to be added to the priming solution composed of concentrated red cells to reach a target of 28-30% hematocrit and plasma to reach the standard volume administered to these patients (400 ml)
Interventions
Eligibility Criteria
You may qualify if:
- weight under 10 kg
- cardiovascular surgery procedure with extracorporeal circulation
- need for hematic priming solution
- elective surgery
- informed consent signed
You may not qualify if:
- congenital disorders of coagulation system
- emergency surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IRCCS San Donato
San Donato Milanese, MI, 20097, Italy
Related Publications (6)
Weil MH, Henning RJ, Puri VK. Colloid oncotic pressure: clinical significance. Crit Care Med. 1979 Mar;7(3):113-6. doi: 10.1097/00003246-197903000-00006. No abstract available.
PMID: 436426BACKGROUNDGolab HD, Scohy TV, de Jong PL, Kissler J, Takkenberg JJ, Bogers AJ. Relevance of colloid oncotic pressure regulation during neonatal and infant cardiopulmonary bypass: a prospective randomized study. Eur J Cardiothorac Surg. 2011 Jun;39(6):886-91. doi: 10.1016/j.ejcts.2010.09.040. Epub 2010 Nov 5.
PMID: 21055963BACKGROUNDChandler WL. Effects of hemodilution, blood loss, and consumption on hemostatic factor levels during cardiopulmonary bypass. J Cardiothorac Vasc Anesth. 2005 Aug;19(4):459-67. doi: 10.1053/j.jvca.2004.11.046.
PMID: 16085250BACKGROUNDOliver WC Jr, Beynen FM, Nuttall GA, Schroeder DR, Ereth MH, Dearani JA, Puga FJ. Blood loss in infants and children for open heart operations: albumin 5% versus fresh-frozen plasma in the prime. Ann Thorac Surg. 2003 May;75(5):1506-12. doi: 10.1016/s0003-4975(02)04991-3.
PMID: 12735570BACKGROUNDMcCall MM, Blackwell MM, Smyre JT, Sistino JJ, Acsell JR, Dorman BH, Bradley SM. Fresh frozen plasma in the pediatric pump prime: a prospective, randomized trial. Ann Thorac Surg. 2004 Mar;77(3):983-7; discussion 987. doi: 10.1016/j.athoracsur.2003.09.030.
PMID: 14992912BACKGROUNDBianchi P, Cotza M, Beccaris C, Silvetti S, Isgro G, Pome G, Giamberti A, Ranucci M; Surgical and Clinical Outcome REsearch (SCORE) group. Early or late fresh frozen plasma administration in newborns and small infants undergoing cardiac surgery: the APPEAR randomized trial. Br J Anaesth. 2017 May 1;118(5):788-796. doi: 10.1093/bja/aex069.
PMID: 28510741DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marco Ranucci, MD, FESC
IRCCS Policlinico S. Donato
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, FESC
Study Record Dates
First Submitted
March 15, 2016
First Posted
April 14, 2016
Study Start
January 1, 2015
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
August 30, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will not share