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Completed

NCT Number: NCT02584868

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

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

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Key information

Conditions

Cardiac Surgery Cardiopulmonary Bypass

Age range

28 day–3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hôpital Universitaire Des Enfants Reine Fabiola

Brussels, 1020, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution

Drug

Peri-operative fluid replacement therapy (max 40ml/kg/day)

Other names: Volulyte

Hydroxyethyl starch 130/0.4 in 0.9% sodium chloride

Drug

Peri-operative fluid replacement therapy (max 40ml/kg/day)

Other names: Voluven

Primary outcomes

  1. Calculated Blood Loss at 3rd Post Operative Day (POD)

    Time frame: 72H post surgery

Secondary outcomes

  1. Intraoperative Blood Loss

    Time frame: End of surgery, an average of 200 minutes

    peri-operative blood losses in ml/kg at the end of surgery

  2. Chest Tube Drainage

    Time frame: 72H post surgery

    Total chest tube drainage during Pediatric Intensive Care Unit (PICU) stay

  3. Total Blood Loss

    Time frame: 72H post surgery

    Total blood loss Intraoperative + chest tube drainage during Pediatric Intensive Care Unit (PICU) stay

  4. Exposure to Any Blood Products

    Time frame: 72H post surgery

    Transfusion of any blood product (intraoperative + during Pediatric Intensive Care Unit stay)

  5. Exposure to Red Blood Cell

    Time frame: 72H post surgery

    Transfusion of Red Blood Cell (intraoperative + during Pediatric Intensive Care Unit stay)

  6. Red Blood Cell Transfused

    Time frame: 72H post surgery

    Red Blood Cell transfused in transfused patients in ml/kg (intraoperative + during Pediatric Intensive Care Unit stay)

  7. Exposure to Fresh Frozen Plasma

    Time frame: 72H post surgery

    Transfusion of Fresh Frozen Plasma (intraoperative and during Pediatric Intensive Care Unit stay)

  8. Fresh Frozen Plasma Transfused

    Time frame: 72H post surgery

    Fresh Frozen Plasma transfusion in ml/kg (intraoperative and during Pediatric Intensive Care Unit stay)

  9. Exposure to Platelets

    Time frame: 72H post surgery

    Transfusion of platelets (intraoperative and during Pediatric Intensive Care Unit stay)

  10. Platelet Transfused

    Time frame: 72H post surgery

    Platelet transfusion in ml/kg (intraoperative and during Pediatric Intensive Care Unit stay)

  11. Creatinine

    Time frame: At admission to the pediatric intensive care unit (Hour 0 Day 0 after surgery)

  12. C-Reactive Protein (CRP)

    Time frame: At admission to the pediatric intensive care unit (Hour 0 Day 0 after surgery)

  13. PTT

    Time frame: End of surgery, an average of 200 minutes

  14. APTT

    Time frame: End of surgery, an average of 200 minutes

  15. INR

    Time frame: End of surgery, an average of 200 minutes

  16. Fibrinogen

    Time frame: End of surgery, an average of 200 minutes

  17. Clotting Time in Seconds

    Time frame: End of surgery, an average of 200 minutes

    Clotting time on EXTEM ROTEM®

  18. Maximal Cloth Firmness

    Time frame: End of surgery, an average of 200 minutes

    Maximal cloth firmness on EXTEM ROTEM®

  19. Creatinine

    Time frame: Post-operative Day 1

  20. CRP

    Time frame: Post-operative Day 1

  21. PTT

    Time frame: Post-operative Day 1

  22. APTT

    Time frame: Post-operative Day 1

  23. INR

    Time frame: Post-operative Day 1

  24. Fibrinogen

    Time frame: Post-operative Day 1

  25. Creatinine

    Time frame: Post-operative Day 2

  26. CRP

    Time frame: Post-operative Day 2

  27. PTT

    Time frame: Post-operative Day 2

  28. APTT

    Time frame: Post-operative Day 2

  29. INR

    Time frame: Post-operative Day 2

  30. Fibrinogen

    Time frame: Post-operative Day 2

  31. Creatinine

    Time frame: Post-operative Day 3

  32. CRP

    Time frame: Post-operative Day 3

Sponsors and collaborators

Lead sponsor

Queen Fabiola Children's University Hospital

Other

Registry information

Acronym: COLCHIRCARD

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Oct 23, 2015
Registry last updated
Nov 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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