Clinical trial NCT00672516: Management of Bleeding Following Cardiopulmonary Bypass
Official title: Management of Excessive Bleeding Following Cardiopulmonary Bypass: A Pilot Feasibility Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemorrhage
Cardiopulmonary Bypass
Keywords: hemorrhage
cardiopulmonary bypass
blood component transfusion
hemostasis, surgical
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: University of Texas Southwestern Medical Center
name: Johns Hopkins University
name: Emory University
First posted: 2008-05-06
Enrollment: 43
Sex: ALL
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.


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

Primary outcomes:
measure: 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
timeFrame: end of trial
measure: 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
timeFrame: During and immediately following completion of bypass OR in the first 24 hours after admission to the IUC, if significant bleeding occurs
measure: 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
timeFrame: First 24 hours after operation
measure: Assess the level of compliance to the Bleeding Management Algorithm
timeFrame: Immediate peri-operative period
Secondary outcomes:
measure: 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
timeFrame: First 30 days post-operatively or until discharge, whichever comes first
measure: Recording serious adverse events, such as myocardial infarction, thrombo-embolic events, etc.
timeFrame: First 30 days post-operatively or discharge, whichever occurs first
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: University of Minnesota
name: Marie E Steiner, MD, MS
role: STUDY_CHAIR
affiliation: University of Texas Souwthwestern Medical Center
name: Philip Greilich, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins Medical Center
name: Nauder Faraday, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Nigel S Key, MB, FRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Jerrold Levy, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1016/j.hoc.2006.11.009.
citation: Levy JH, Tanaka KA, Steiner ME. Evaluation and management of bleeding during cardiac surgery. Curr Hematol Rep. 2005 Sep;4(5):368-72.
citation: 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.