The Effect of Washing Red Blood Cells on Post Heart Surgery Blood Loss

NCT00624611 | Completed Phase 3

• 1 other identifier: H07-01444
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

When a child undergoes heart surgery, a heart lung machine is used to keep blood flowing while the child's own heart is stopped. After surgery, a significant amount of the child's own blood is left in this machine. In the case of small children, the relative amount of blood potentially lost to the child in this way is very large. In older children, and those who have undergone less complicated surgery, this blood can all returned to the child. Giving the child back his or her own blood makes is less likely that the child will need a transfusion of donated blood. However, in younger children, or in children who have undergone more complicated surgery, most or all of this blood is thrown away. This is because of worry that returning this blood may cause bleeding, and excessive bleeding is one of the most feared complications of heart surgery. This project will explore a method whereby the red blood cells left in the heart lung machine can be returned to children without increasing the risk of bleeding. It will also carefully examine the exact causes of higher bleeding risk in children getting their own blood back so that in the future, all children can have their own blood returned at the end of surgery.

Conditions

Cardiopulmonary Bypass

Keywords

CPB; red blood cell washing

Outcome Measures

Primary Outcomes (1)

• Total perioperative blood loss

  During surgery

Secondary Outcomes (1)

• Components of the hemostatic profile will be compared between groups as secondary outcome variables

  24 hours

Study Arms (2)

1

ACTIVE COMPARATOR

Residual pump blood management post aortic cannula removal

Procedure: Residual pump blood management post aortic cannula removal

2

EXPERIMENTAL

Residual pump blood management post aortic cannula removal

Procedure: Residual pump blood management post aortic cannula removal

Interventions

Residual pump blood management post aortic cannula removal PROCEDURE

Residual pump blood will be maximally hemoconcentrated by further ultrafiltation within the CPB machine. Resulting hematocrit will be approximately 0.4. The total residual pump blood volume, approximately 300ml, will be reinfused over one hour, beginning 15 minutes after removal of the aortic cross clamp. Additional protamine sulfate will be given every 30 minutes during the infusion, .03 mg/ml of residual pump blood. Procedures in this group do not deviate from current standard practice.

1

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children between 15 and 30 kg undergoing cardiac surgery requiring cardiopulmonary bypass at British Columbia's Children's Hospital.
• All children will be between 2 and 10 years of age.
• Surgery will only involve single atriotomy.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

BC Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

Location

Study Officials

• Norbert Froese, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• John Wu

  University of British Columbia

  STUDY DIRECTOR

• Jacques LeBlanc

  University of British Columbia

  STUDY DIRECTOR

• Andrew Campbell

  University of British Columbia

  STUDY DIRECTOR

• Doug Salt

  University of British Columbia

  STUDY DIRECTOR

• Pascal Lavoie

  University of British Columbia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 13, 2008
• First Posted: February 27, 2008
• Study Start: February 1, 2008
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: April 14, 2011

Record last verified: 2011-04

Locations

CA (1)