Management of Bleeding Following Cardiopulmonary Bypass

University of Minnesota (UMN)

Status: Completed

Conditions: Hemorrhage; Cardiopulmonary Bypass

Study type: Observational

Funder types: Other

Identifiers

NCT00672516

20100962-A1

0604M85353

Details and patient eligibility

About

We believe ongoing bleeding during complex cardiac surgery can be accurately measured and that administration of a specific blood product replacement strategy designed to optimally slow or stop the bleeding can be followed by the during the operation.

Patients at risk of significant bleeding after complex cardiac surgery will be approached to allow their operation to be watched by study personnel to see if ongoing blood loss can be accurately measured and to see how quickly a prescribed, standardized blood product replacement protocol to control the bleeding does slow or stop the bleeding. Permission to review the medical record to see if bleeding risk features can be identified and permission to follow the patient after surgery to see how they recover is also requested.

Enrollment: 43 patients

Sex: All

Ages: Under 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Eligible male and female patients will include those who are over 18 kg (identified as the lower inclusion threshold so as to standardize CPB circuit dilution) and less than 75 years old (to limit excessive stroke risk) and at theoretically increased risk for excessive bleeding following cardiopulmonary bypass, including patients:

1. undergoing repeat sternotomy, or
2. undergoing combined procedures (i.e. - valve and coronary artery surgery), or
3. undergoing multiple valve surgery, or
4. undergoing aortic root replacement with/without deep hypothermic circulatory arrest, or
5. undergoing complex congenital cardiac surgery

Exclusion criteria

Ineligible patients include those:

1. with known coagulation factor deficiency, or
2. refusing to receive donor blood products if necessary, or
3. undergoing emergency surgery, or
4. undergoing their first coronary artery bypass surgery or their first valve repair/replacement, or
5. with history of previous stroke or other significant thromboembolic event within 6 months (such as pulmonary embolism, valve obstruction [if not replacing this valve in upcoming operation], renal vein thrombosis, acute MI, DVT ), or
6. with known thrombophilia, or
7. with active infection (bacteremia, sepsis, endocarditis, meningitis, urinary tract infection, cholecystitis, cellulitis, pneumonia)
8. pregnant, or
9. weight > 150 kg or < 18 kg