Management of Bleeding Following Cardiopulmonary Bypass

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by University of Minnesota - Clinical and Translational Science Institute.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
University of Texas Southwestern Medical Center
Johns Hopkins University
Emory University
Information provided by:
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00672516
First received: May 2, 2008
Last updated: February 24, 2009
Last verified: February 2009
  Purpose

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.


Condition
Hemorrhage
Cardiopulmonary Bypass

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Management of Excessive Bleeding Following Cardiopulmonary Bypass: A Pilot Feasibility Study

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Assess the level of compliance to the Bleeding Management Algorithm [ Time Frame: Immediate peri-operative period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Recording serious adverse events, such as myocardial infarction, thrombo-embolic events, etc. [ Time Frame: First 30 days post-operatively or discharge, whichever occurs first ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: April 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00672516

Contacts
Contact: Marie E Steiner, MD, MS 612-626-2778 stein083@umn.edu

Locations
United States, Minnesota
University of Minnesota Not yet recruiting
Minneapolis, Minnesota, United States, 55436
Contact: Marie E Steiner, MD, MS    612-626-2778    stein083@umn.edu   
Principal Investigator: Marie E Steiner, MD, MS         
United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390-8894
Contact: Philip E Greilich, MD    214-645-8089    Philip.Greilich@UTSouthwestern.edu   
Principal Investigator: Philip E Greilich, MD         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
University of Texas Southwestern Medical Center
Johns Hopkins University
Emory University
Investigators
Study Chair: Marie E Steiner, MD, MS University of Minnesota - Clinical and Translational Science Institute
Principal Investigator: 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
  More Information

Publications:
Responsible Party: Marie E. Steiner, MD, MS, University of Minnesota
ClinicalTrials.gov Identifier: NCT00672516     History of Changes
Other Study ID Numbers: 0604M85353, 20100962-A1
Study First Received: May 2, 2008
Last Updated: February 24, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
hemorrhage
cardiopulmonary bypass
blood component transfusion
hemostasis, surgical

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on July 24, 2014