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

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

Interventions

PROCEDURE

Residual pump blood management post aortic cannula removal

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.

PROCEDURE

Residual pump blood management post aortic cannula removal

All residual pump blood will be processed with a bedside red cell washing device (Cell Saver). The resulting total volume of concentrated red cells will be infused over one hour, beginning 15 minutes after removal of the aortic cross clamp. Administration of additional protamine is not required due to the low concentrations of heparin in the resulting product.

Sponsors & Collaborators

• University of British Columbia

  lead OTHER

Principal Investigators

• Norbert Froese, MD · University of British Columbia

• John Wu · University of British Columbia

• Jacques LeBlanc · University of British Columbia

• Andrew Campbell · University of British Columbia

• Doug Salt · University of British Columbia

• Pascal Lavoie · University of British Columbia

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

2 Years

Max Age

10 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-02-29

Primary Completion

2010-08-31

Completion

2010-08-31

Countries

• Canada

Study Locations