Colloids in Pediatric Cardiac Surgery: Comparison Between a Balanced and a Non-balanced Colloid

Cardiac Surgery Clinical Trial

— COLCHIRCARD  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02584868
• Other study ID #: 2011-006034-17
• Status: Completed
• Phase: Phase 3
• Start date: February 15, 2013
• Est. completion date: November 21, 2016

Study information

• Verified date: February 2017
• Source: Queen Fabiola Children's University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will compare the clinical efficacy and safety of Volulyte® and Voluven® during elective open-heart surgery in pediatric patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: November 21, 2016
• Est. primary completion date: November 21, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Years

Eligibility

Inclusion Criteria:

• Age 28 days to 3 years old

• Planned cardiac surgery with cardiopulmonary by-pass

• signed informed consent

Exclusion Criteria:

• Moribund patients (ASA 5)

• Jehovah Witnesses

• Pre-operative coagulation disorders

• Pre-operative renal insufficiency

• Pre-operative hepatic disorders

• Intra-cranial hemorrhage

• hypernatremia

Related Conditions & MeSH terms

• Cardiac Surgery
• Cardiopulmonary Bypass

Intervention

Drug:
• Hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution
Peri-operative fluid replacement therapy (max 40ml/kg/day)
• Hydroxyethyl starch 130/0.4 in 0.9% sodium chloride
Peri-operative fluid replacement therapy (max 40ml/kg/day)

Locations

Country	Name	City	State
Belgium	Hôpital Universitaire Des Enfants Reine Fabiola	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Queen Fabiola Children's University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Calculated Blood Loss at 3rd Post Operative Day (POD)		72H post surgery
Secondary	Intraoperative Blood Loss	peri-operative blood losses in ml/kg at the end of surgery	End of surgery, an average of 200 minutes
Secondary	Chest Tube Drainage	Total chest tube drainage during Pediatric Intensive Care Unit (PICU) stay	72H post surgery
Secondary	Total Blood Loss	Total blood loss Intraoperative + chest tube drainage during Pediatric Intensive Care Unit (PICU) stay	72H post surgery
Secondary	Exposure to Any Blood Products	Transfusion of any blood product (intraoperative + during Pediatric Intensive Care Unit stay)	72H post surgery
Secondary	Exposure to Red Blood Cell	Transfusion of Red Blood Cell (intraoperative + during Pediatric Intensive Care Unit stay)	72H post surgery
Secondary	Red Blood Cell Transfused	Red Blood Cell transfused in transfused patients in ml/kg (intraoperative + during Pediatric Intensive Care Unit stay)	72H post surgery
Secondary	Exposure to Fresh Frozen Plasma	Transfusion of Fresh Frozen Plasma (intraoperative and during Pediatric Intensive Care Unit stay)	72H post surgery
Secondary	Fresh Frozen Plasma Transfused	Fresh Frozen Plasma transfusion in ml/kg (intraoperative and during Pediatric Intensive Care Unit stay)	72H post surgery
Secondary	Exposure to Platelets	Transfusion of platelets (intraoperative and during Pediatric Intensive Care Unit stay)	72H post surgery
Secondary	Platelet Transfused	Platelet transfusion in ml/kg (intraoperative and during Pediatric Intensive Care Unit stay)	72H post surgery
Secondary	Creatinine		At admission to the pediatric intensive care unit (Hour 0 Day 0 after surgery)
Secondary	C-Reactive Protein (CRP)		At admission to the pediatric intensive care unit (Hour 0 Day 0 after surgery)
Secondary	PTT		End of surgery, an average of 200 minutes
Secondary	APTT		End of surgery, an average of 200 minutes
Secondary	INR		End of surgery, an average of 200 minutes
Secondary	Fibrinogen		End of surgery, an average of 200 minutes
Secondary	Clotting Time in Seconds	Clotting time on EXTEM ROTEM®	End of surgery, an average of 200 minutes
Secondary	Maximal Cloth Firmness	Maximal cloth firmness on EXTEM ROTEM®	End of surgery, an average of 200 minutes
Secondary	Creatinine		Post-operative Day 1
Secondary	CRP		Post-operative Day 1
Secondary	PTT		Post-operative Day 1
Secondary	APTT		Post-operative Day 1
Secondary	INR		Post-operative Day 1
Secondary	Fibrinogen		Post-operative Day 1
Secondary	Creatinine		Post-operative Day 2
Secondary	CRP		Post-operative Day 2
Secondary	PTT		Post-operative Day 2
Secondary	APTT		Post-operative Day 2
Secondary	INR		Post-operative Day 2
Secondary	Fibrinogen		Post-operative Day 2
Secondary	Creatinine		Post-operative Day 3
Secondary	CRP		Post-operative Day 3