A Study to Compare FEIBA to Alternative Blood Products in Treating Children After Cardiac Surgery

Overview

About this study

The purpose of this study is to determine the effectiveness and safety of aPCC FEIBA in children undergoing cardiac surgery with cardiopulmonary bypass.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Weight ≤ 15 kg.
  • Elective cardiac surgery with cardiopulmonary bypass.
  • Coagulopathic bleeding after cardiopulmonary bypass.
  • Availability and willingness of the parent/legal guardian to provide informed consent.

Exclusion Criteria:

  • Presence of mechanical circulatory support at the time of randomization or POD 0 and 1.
  • Patient or family history of coagulopathy and/or thromboses.
  • Preoperative anticoagulation (excluding low dose heparin for “line prophylaxis”).

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Elena Ashikhmina, M.D., Ph.D.

Open for enrollment

Contact information:

Elena Ashikhmina M.D., Ph.D.

(507) 422-0115

Ashikhmina.Elena@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20521067

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