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Virginia Cardiac Surgery Quality Initiative’s Multi-Center Red Blood Cell Transfusion Study

Investigators for VCSQI:  Vigneshwar Kasirajan, MD, Ivan Crosby, MD, Alan Speir, MD, Angel Medina, Geoffrey Newton

III. Conflict of Interest:  There is no conflict of interest for the investigators in this study

  1. Hypothesis:

VCSQI is a voluntary consortium of 17 hospitals and 13 cardiac surgical practices providing open-heart surgery in the Commonwealth of Virginia. VSCQI hospital members include two national health systems (one for-profit and one religious), two regionally integrated delivery systems, two state university health sciences centers, and 5 regional medical centers and community hospitals. This group performs over 99 percent of Virginia’s open-heart procedures. The group has convened since 1996, comparing data and exchanging information to improve the quality of surgical care and contain costs. A collaborative effort of this magnitude could dramatically influence blood product usage by adopting specific evidence based guidelines. Additionally, valuable outcomes data would be obtained with statistically significant numbers to provide feedback on other variables suspected to be improved by adopting these practices. These variables are mortality, length of hospital stay, and complications. This information once published could influence practice on a national scale ultimately saving lives, improving outcomes, decreasing healthcare costs and increasing blood availability.

  1. Specific Aims:

Our goal is to enlist as many of the Virginia Cardiac Surgery Quality Initiative Participants to adopt a RBC transfusion protocol. Data routinely collected in the Society of Thoracic Surgery Adult Cardiac Surgery Database for purposes of Quality Improvement, and several protocol specific fields from existing data will be used to evaluate outcomes.  Data from sites not adopting the protocol, and historical data will be used as a comparison. We propose to demonstrate the benefit of adopting the evidence based guidelines related to blood product utilization.

  1. Background and Significance:

Cardiac surgery accounts for 20 percent of blood transfused within the United States.1 Today 30-65 percent of patients undergoing cardiac surgery receive a blood transfusion 2-3 and often receive more than one unit. The risk of virus transmission from transfusion is radically decreased since the 1990’s therefore the focus upon transfusion risks is shifting.  Red cell function (ability to carry and release oxygen), immune modulation, transfusion related acute lung injury, cytokine generation, allergic reaction and ABO incompatibility have become the risks of transfusion.4-8   Today an emerging literature is noting that blood transfusions are associated with worse outcome, longer hospital and ICU stays, decreased post-operative quality of life and even increased mortality after heart surgery out to 60 months.4-9  A recent survey of Canadian heart surgeons and anesthesiologists found their transfusion trigger was higher in elderly (age>75yo) and in those patients with depressed myocardial function or recent MI.2,3  Recent work in microcirculation shows that banked blood does not increase critical oxygen delivery and may well decrease it, and even though arterial blood gases are improved, the current practice of transfusing older more ill patients at a higher transfusion trigger could be unwise.  Hébert et al performed a randomized trial of transfusion at two different triggers in critically ill medical ICU patients. In hospital deaths were reduced 25 percent by transfusing less or at a more anemic trigger.10 MI’s were decreased 75 percent and pulmonary dysfunction was reduced by 50 percent in patients who received less blood. An aggressive education approach at our single center has led to the development of a consensus and blood conservation approach for our cardiac patients. We have lowered our transfusion triggers as well as adopted a 9-12 point program to conserve the patient’s own blood. Our transfusion utilization has dropped from before the program, 70 percent of all patients transfused, to now 12-22 percent. From our program, morbidity and mortality are not worse and in a number of respects, improved. It is clear from the gathering literature that transfusion of banked blood to heart surgery patients is institution specific, in terms of triggers invoked and that science with regards to the “best” practice is sorely lacking. There is also increasing evidence that transfusions during cardiac surgery in women leads to even worse outcomes than in men. Women tend to be transfused more perhaps due to lower circulating blood volumes.  The opportunity for a cooperative group of centers of excellence in cardiac surgery to prospectively evaluate transfusion data would dramatically advance knowledge in this area.

VII. Preliminary Progress/Data report: Dated July 8, 2008

The Virginia Cardiac Surgery Quality Initiative met March 06, 2008 and has agreed to participate collaboratively in the aforementioned study. At this time the protocol triggers have been agreed to. Currently, 15 of VCSQI’s 17 member hospitals and practices have agreed to participate or expressed interest. Those sites not participating at this time will be compared to participating sites through the data collaborative.

VIII. Research Method and Design:

All patients undergoing cardiac surgery will be included in the study without exclusions or randomization. Data will be collected retrospectively from patients undergoing cardiac surgery with usual practice and the guidelines in place.

The anesthetic regimen will be at the discretion of the attending anesthesiologist and the conduct of the cardiac surgery will be per the usual practice of the surgeon. The use of anti-fibrinolytic will be per anesthesia/surgery team, however, the goal will be to standardize their dosing. Goals will also have to be established for weaning protocols, but the routine care of the patient will be per institutional practices. Retrospective data collected from participating sites will be compared with historical data and the data of non-participating sites.

Patients will only be transfused following the guidelines below as established by the Society of Thoracic Surgery and the Society of Cardiovascular Anesthesia.11

Transfusion Triggers:

On Pump RBC transfusion for Hgb < 6.0 or HCT <18 + One objective criteria for tissue hypoperfusion.

  • Low SVO2
  • Elevated Lactate
  • Elevated base deficit, Low HCO3

Post Op ( ICU and Step Down Units )  RBC transfusion for Hgb < 7.0 or HCT <21 + One objective criteria .

  • Elevated O2 need
  • Hypotension
  • End Organ dysfunction
  • Ongoing Bleeding

Follow Up:

The following data will be collected for each patient:

All data routinely collected for the STS Adult Cardiac Surgery Database will be collected as usually done for quality improvement purposes. In addition the following custom fields will be collected retrospectively.

  • Pre-Op Hgb/Hct
  • Hgb/Hct Pre-Bypass
  • Lowest Hgb/Hct on Bypass
  • Hgb/Hct at end of surgery
  • Hgb/Hct at discharge from ICU
  • Hgb/Hct at discharge from hospital
  • Hgb/Hct at first post-op visit
  • Amicar vs. Aprotinin vs. None
  • Retrograde Autologous Priming
  • Ultrafiltration
  • Degree of hypothermia
  • Cell saver use
  • Volume of Cardioplegia
  • Total volume of Crystalloid/Colloid during surgery.
  • Leukoreduced v. Non-leukoreduced
  • Factor VIIa
  • Every unit transfused will be recorded with the time and Hgb/Hct trigger.
  • Date blood was harvested.

Other indicators to be followed which are part of the STS database:

ASA or Plavix within 24 hours of surgery (pre-op)

CABG – On Pump or Off Pump

Other Blood Product Usage

  • Platelets
  • FFP
  • Cryoprecipitate
  1. Statistical Analysis:

The use of blood products, mortality, complications and hospital LOS will be compared to pre-protocol data and from those sites not participating.

  1. Data and Safety Monitoring:

The VCSQI currently pools data from the individual STS Databases at each site into a collaborative data set that is de-identified and HIPPA compliant. This collaborative dataset is maintained by ARMUS Corporation.  Each site has a business service agreement, and HIPPA agreement with ARMUS.  Data is de-identified and blinded by site.  VCSQI and ARMUS evaluate the database on an ongoing basis to protect confidentiality of records. No Protected Health Information (PHI) is submitted to ARMUS or the STS.

  1. Human Subject Instructions
  1. Description: Research participants include adult patients ( >18 yrs) that undergo cardiothoracic surgery.
  2. Research Material: Clinical data will be collected from existing medical records.
  3. Recruitment plan: All adult patients with the history of cardiothoracic surgery.
  4. Potential Risks: Non-Applicable
  5. Risk Reduction: Standard precautions will be taken to protect the participants’ information as is customary to the Society of Thoracic Surgery Adult Cardiac Database.
  1. Confidentiality: Data is collected and all personal information will be deleted to protect the subject’s Identity. Once the identifiers are removed, the information will be shared submitted to the VCSQI database maintained by ARMUS Corporation.
  2. Risk/Benefit: There is no risk involved with the study beyond risks usually associated with standard practice of cardiac surgery. The adopted protocol has been widely accepted as evidence based by guidelines for the Society of Thoracic Surgery and Society of Cardiovascular Anesthesia.11 This protocol has been used at VCU since 2005.
  3. Compensation plan: Non-Applicable
  4. Consent issues:
  1. Consent setting: Non-Applicable.
  2. Comprehension: Non-Applicable
    1. Special Consent Provisions: Non-Applicable
    2. Assent Process for Children: Non-Applicable
    3. Waive the Requirement to obtain prospective consent from children: Non-Applicable
    4. Waive the requirement to obtain prospective informed consent: There is no more than minimal risk to the patient because there will be no human/patient contact. This review only collects retrospective data, no identifying information is required. Medical treatment, rights and welfare of the subject will not be altered because of the waiver.
    5. Waive documentation of consent: The research presents no more than minimal risk of harm to subjects and involves no procedure for which written consent is normally required outside of the research context.
    6. Genetic testing
  1. Future contact concerning genetic testing research: Non-Applicable
  2. Future contact concerning genetic testing results: Non-Applicable
  3. Withdrawal of genetic testing consent: Non-Applicable
  4. Genetic testing involving children or decision-impaired subjects: Non-Applicable
  5. Confidentiality: VCU, STS, ARMUS, DCRI is fully compliant with the Health Insurance Portability and Accountability Act.

References

  1. Belisle S, Hardy JF. Hemorrhage and the use of blood products after adult cardiac operations: Myths and realities. Ann Thorac Surg 1996;62:1098-17.
    2. Alghamdi A et al. Development and validation of transfusion risk understanding scoring tool (Trust) to stratify cardiac surgery patients according to their blood transfusion needs. Transfusion 2006;46:1120-9.
    3. Banbury MK et al. Transfusion increases the risk of postoperative infection after cardiac surgery. J Am Col Surg 2006;202:131-138.
    4. Leal-Noval et al. Chest 2001;119:1461.
    5. Leal-Noval SR, et al. Influence of erythrocyte concentrate storage time on postsurgical morbidity in cardiac surgery patients. Anesthesiology 2003;98:815-22.
    6. Koch CG et al. Persistent effect of red cell transfusion on health-related quality of life after cardiac surgery. Ann Thorac Surg 2006;82:13-20.
    7. Engoren M, et al. Effect of blood transfusion on long-term survival after cardiac operation. Ann Thorac Surg 2002;74:1180-6.
    8. Tsai A, Cabrales P, Intaglietta M. Microvascular perfusion upon exchange transfusion with stored red blood cells in normovolemic anemic conditions. Transfusion 2004;44:1626-1634.
    9. Hebert PC et al. A multicenter, randomized, controlled clinical trial of transfusion requirements in critical care. NEJM 1999;340:409-417.
    10. Green J. J Cardiothoracic Vasc Anesth, Suppl 2004.
  2. Ferraris, V. A., Speisss, B. D. Perioperative blood transfusion and blood conservation in cardiac surgery: The Society of Thoracic Surgeons and The Society of Cardiovascular Anesthesiologists Clinical Practice Guideline. Ann Thorac Surg 2007;83:S27-86