Colloids in Pediatric Cardiac Surgery: Comparison Between a Balanced and a Non-balanced Colloid
COLCHIRCARD
1 other identifier
interventional
88
1 country
1
Brief Summary
This study will compare the clinical efficacy and safety of Volulyte® and Voluven® during elective open-heart surgery in pediatric patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Feb 2013
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 15, 2013
CompletedFirst Submitted
Initial submission to the registry
July 3, 2013
CompletedFirst Posted
Study publicly available on registry
October 23, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 21, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 21, 2016
CompletedResults Posted
Study results publicly available
November 9, 2020
CompletedNovember 9, 2020
February 1, 2017
3.8 years
July 3, 2013
June 10, 2020
October 16, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Calculated Blood Loss at 3rd Post Operative Day (POD)
72H post surgery
Secondary Outcomes (32)
Intraoperative Blood Loss
End of surgery, an average of 200 minutes
Chest Tube Drainage
72H post surgery
Total Blood Loss
72H post surgery
Exposure to Any Blood Products
72H post surgery
Exposure to Red Blood Cell
72H post surgery
- +27 more secondary outcomes
Study Arms (2)
Volulyte
EXPERIMENTALInvestigational drug: HES 130/0.4 (6%) in an isotonic electrolyte solution (brand name=Volulyte®)
Voluven
ACTIVE COMPARATORControl drug: HES 130/0.4 (6%) in sodium chloride 0.9% (brand name=Voluven®)
Interventions
Peri-operative fluid replacement therapy (max 40ml/kg/day)
Peri-operative fluid replacement therapy (max 40ml/kg/day)
Eligibility Criteria
You may qualify if:
- Age 28 days to 3 years old
- Planned cardiac surgery with cardiopulmonary by-pass
- signed informed consent
You may not qualify if:
- Moribund patients (ASA 5)
- Jehovah Witnesses
- Pre-operative coagulation disorders
- Pre-operative renal insufficiency
- Pre-operative hepatic disorders
- Intra-cranial hemorrhage
- hypernatremia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Universitaire Des Enfants Reine Fabiola
Brussels, 1020, Belgium
Related Publications (1)
Willems A, De Groote F, Schmartz D, Fils JF, Van der Linden P. Does a balanced colloid decrease perioperative blood loss in paediatric cardiac surgery: A double-blinded randomized controlled trial? Eur J Anaesthesiol. 2021 Sep 1;38(9):923-931. doi: 10.1097/EJA.0000000000001526.
PMID: 33966019DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Philippe Van der Linden, MD, PhD
- Organization
- Centre Hospitalier Universitaire Brugmann
Study Officials
- PRINCIPAL INVESTIGATOR
Philippe Van der Linden, MDPhD
HUDERF
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 3, 2013
First Posted
October 23, 2015
Study Start
February 15, 2013
Primary Completion
November 21, 2016
Study Completion
November 21, 2016
Last Updated
November 9, 2020
Results First Posted
November 9, 2020
Record last verified: 2017-02