Management of Bleeding Following Cardiopulmonary Bypass

NCT00672516 | Completed

• 2 other identifiers: 0604M8535320100962-A1
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

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

Keywords

hemorrhage; cardiopulmonary bypass; blood component transfusion; hemostasis, surgical

Outcome Measures

Primary Outcomes (4)

• Tabulate the number of high risk subjects that must be screened and consented in order to find twenty subjects that meet the criteria of excessive bleeding following conventional therapy

  end of trial

• Determine blood loss, bleeding rate and blood transfusion prior to and following completion of algorithm-guided conventional transfusion therapy,including measured loss, rate of loss, volume of transfusion

  During and immediately following completion of bypass OR in the first 24 hours after admission to the IUC, if significant bleeding occurs

• Assess the relative accuracy and clinical relevance of measuring bleeding rate, blood loss and blood transfusion in the first 24 hours following designation of "excessive bleeding", including measured hourly outputs, rate of output and volume transfused

  First 24 hours after operation

• Assess the level of compliance to the Bleeding Management Algorithm

  Immediate peri-operative period

Secondary Outcomes (2)

• Tabulating adverse outcomes, including: 1) rate of re-exploration within the next 24 hours, 2) use of rescue therapeutics in accordance with local practice, and 3) mortality within 30 days

  First 30 days post-operatively or until discharge, whichever comes first

• Recording serious adverse events, such as myocardial infarction, thrombo-embolic events, etc.

  First 30 days post-operatively or discharge, whichever occurs first

Eligibility Criteria

• Age: Up to 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study populations includes male and female patients over 18 kg in weight and less than 75 years old who are undergoing cardiopulmonary bypass and are theoretically at risk for significant bleeding in the peri-operative period

You may qualify if:

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

You may not qualify if:

• Ineligible patients include those:
• with known coagulation factor deficiency, or
• refusing to receive donor blood products if necessary, or
• undergoing emergency surgery, or
• undergoing their first coronary artery bypass surgery or their first valve repair/replacement, or
• 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
• with known thrombophilia, or
• with active infection (bacteremia, sepsis, endocarditis, meningitis, urinary tract infection, cholecystitis, cellulitis, pneumonia)
• pregnant, or
• weight \> 150 kg or \< 18 kg

Sponsors & Collaborators

• University of Minnesota: lead
• University of Texas Southwestern Medical Center: collaborator
• Johns Hopkins University: collaborator
• Emory University: collaborator

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390-8894, United States

Location

Related Publications (3)

• 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.

  PMID: 17258126 BACKGROUND

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

  PMID: 16131437 BACKGROUND

• 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.

  PMID: 14722166 BACKGROUND

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marie E Steiner, MD, MS

  University of Minnesota

  STUDY CHAIR

• Philip Greilich, MD

  University of Texas Souwthwestern Medical Center

  PRINCIPAL INVESTIGATOR

• Nauder Faraday, MD

  Johns Hopkins Medical Center

  PRINCIPAL INVESTIGATOR

• Nigel S Key, MB, FRCP

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Jerrold Levy, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2008
• First Posted: May 6, 2008
• Study Start: April 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: May 28, 2015

Record last verified: 2015-05

Locations

US (1)