Management of Bleeding Following Cardiopulmonary Bypass

NCT ID: NCT00672516

Last Updated: 2015-05-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 43 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2009-05-31

Brief Summary

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.

Conditions

Hemorrhage; Cardiopulmonary Bypass

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marie E Steiner, MD, MS

Role: STUDY_CHAIR

University of Minnesota

Philip Greilich, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Souwthwestern Medical Center

Nauder Faraday, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Medical Center

Nigel S Key, MB, FRCP

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Jerrold Levy, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Countries

United States

References

Steiner ME, Despotis GJ. Transfusion algorithms and how they apply to blood conservation: the high-risk cardiac surgical patient. Hematol Oncol Clin North Am. 2007 Feb;21(1):177-84. doi: 10.1016/j.hoc.2006.11.009.

Reference Type: BACKGROUND

PMID: 17258126 (View on PubMed)

Levy JH, Tanaka KA, Steiner ME. Evaluation and management of bleeding during cardiac surgery. Curr Hematol Rep. 2005 Sep;4(5):368-72.

Reference Type: BACKGROUND

PMID: 16131437 (View on PubMed)

Avidan MS, Alcock EL, Da Fonseca J, Ponte J, Desai JB, Despotis GJ, Hunt BJ. Comparison of structured use of routine laboratory tests or near-patient assessment with clinical judgement in the management of bleeding after cardiac surgery. Br J Anaesth. 2004 Feb;92(2):178-86. doi: 10.1093/bja/aeh037.

Reference Type: BACKGROUND

PMID: 14722166 (View on PubMed)

Other Identifiers

20100962-A1

Identifier Type: -

Identifier Source: secondary_id

0604M85353

Identifier Type: -

Identifier Source: org_study_id