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Completed

NCT Number: NCT00672516

Management of Bleeding Following Cardiopulmonary Bypass

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.

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Key information

Conditions

Hemorrhage Cardiopulmonary Bypass Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

Up to 75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390-8894, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • 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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 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

    Time frame: end of trial

  2. 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

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

  3. 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

    Time frame: First 24 hours after operation

  4. Assess the level of compliance to the Bleeding Management Algorithm

    Time frame: Immediate peri-operative period

Secondary outcomes

  1. 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

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

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

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

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • Emory University
  • Johns Hopkins University
  • University of Texas Southwestern Medical Center

Registry information

Official study title

Management of Excessive Bleeding Following Cardiopulmonary Bypass: A Pilot Feasibility Study

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
May 6, 2008
Registry last updated
May 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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