Management of Bleeding Following Cardiopulmonary Bypass

Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00672516
• Other study ID #: 0604M85353
• Secondary ID: 20100962-A1
• Status: Completed
• Phase: N/A
• First received: May 2, 2008
• Last updated: May 26, 2015
• Start date: April 2008
• Est. completion date: May 2009

Study information

• Verified date: May 2015
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 75 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiopulmonary Bypass
• Hemorrhage

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center	Dallas	Texas

Sponsors (4)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute	Emory University, Johns Hopkins University, University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	Assess the level of compliance to the Bleeding Management Algorithm		Immediate peri-operative period	No
Secondary	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	Yes
Secondary	Recording serious adverse events, such as myocardial infarction, thrombo-embolic events, etc.		First 30 days post-operatively or discharge, whichever occurs first	Yes