BLOOD TRANSFUSION RESEARCH USING ELECTRONIC DATABASES: THE NHLBI REDS-III PROGRAM

Beth St. Lezin, MDEd Murphy, MD, MPHNareg Roubinian, MDBrian Custer, MPH, PhDRoberta Bruhn, MS, PhDAnne Guiltinan, MA, LMFT

Ebi Fiebig, MDAshok Nambiar, MD

REDS: History and Acronyms

1989 2005 2011 2018

REDS REDS-II REDS-III2006 – International Programs

REDS and REDS-II= RetrovirusEpidemiologyDonor Study

REDS –III = Recipient Epidemiology and Donor evaluationStudy

Domestic Program

Address scientific research priorities in blood banking and transfusion medicine in the US

Continue research aimed at donor/donations and blood banking issues Start to address transfusion practice and recipient risk issues:

Evaluating blood product utilization practices in various clinical settings and in specific patient populations and their associated outcomes and costs

Evaluating the risks of allogeneic blood transfusion and their determinants on clinical outcomes

Evaluating the potential clinical benefit(s) of introducing a modified product or treatment strategy

Characterization of the risks, benefits, and clinical outcomes of prophylactic versus therapeutic transfusion strategies, and alternatives to allogeneic transfusions

Education and training component

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REDS-III Institutional Infrastructure

Yale/New England ARC

ITxM

BCW

UCSF/BCP

BSRI/Brazil Hub(4 Blood centers)

JHU/China(5 Blood Centers)

UCSF/South Africa(SANBS)

CL(BSRI)

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Hospitals U.S. Hubs NHLBI US-Foreign Partnerships

DCC(RTI)

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Domestic Program – Phase 2

Planned Phase 2 studies:1. RBC Transfusion in the Elderly Transfusion

Outcomes (RETRO)• 6 minute walk test and quality of life surveys

2. Severe Transfusion Reactions including Pulmonary Edema (STRIPE)• Active surveillance of tx reactions and a case-

control study of TACO3. Genetic basis of differential RBC storage

capacity and iron balance and clinical syndromes in high Intensity blood donors (RBC-Omics)• GWAS of 14,000 donors characterized by

hemolysis of their stored RBCs and by their donation intensity

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REDS-III Database Approach

• Monthly downloads of type & cross and issued unit data from hospital transfusion services

• Matching to clinical data from hospital medical information system

• Identity coding by honest broker function and uploading data to secure MyResearch website

• Download data to CCC and matching to donor/donation database

• Formulation of three deliverable databases

UCSFMCApex EMR

VAMCVista EMR

THREDS& CTSI ARS

VAMC programmer

Clarity Tables to IT

consultant

BCPBlood Donor & Blood Product

Data

UCSF/BSRIREDS-III Hub

CTSIMyResearch

Honest Broker

SFGHEMR

Donation Components RecipientDatabases sent to

REDS-III Data Coordinating Center

REDS-IIIData Flow

Blood Components Data

Combined Data

VADonor & Donation Data

UCSF

VA

SF GH

Snap-shot of SFGH Pilot data Recipient Gender Age Race Diagnosis Service Discharge

ID           Diagnosis

2 Male 54 WhiteAnemia Chr Disease Nec Medicine Longterm Care

       End Stage Renal Disease

Mental Health Rehab.

Dead, Other Death, Autopsy Performed

        Atrial Fibrillation    

        Cachexia    

Blood Unit ID Blood Transfusion Donation Donation

  Component Date Number Date

W117009128332LRA RBC 11/12/2009 W117009128332005 10/31/2009

W117009133548LRA RBC 11/13/2009W11700913354800

L 11/5/2009

Donor ID Sex Age Race Education Donor Procedure Donation

          Type Type Type

650060371993 Male 17 Hispanic High School or less First Whole Blood Homologous

650060304177 Male 52 White Master's or Professional Degree Repeat Whole Blood Homologous

Patient Database

Components Database

Donor/ Donation Database

Snap-shot of SFGH Pilot data Patient Database Components Database Donor/Donation Database Recipient Gender Age Race Diagnosis Service Discharge Blood Unit ID Blood Transfusion Donation Donation Donor ID Gender Age Race Education Donor Procedure

ID Status Component Date Number Date Type Type

SFGH001 Female 47 Black Acc Pois-Anticonvulsant Family Medicine Routine W117009130462LRA RBC 11/12/2009 W117009130462007 11/3/2009 650060305992 Female 38 White Some College/Tech.School First Whole BloodEnd Stage Renal Disease Discharge Home

SFGH002 Male 54 White Anemia Chr Disease Nec Medicine Longterm Care W117009128332LRA RBC 11/12/2009 W117009128332005 10/31/2009 650060371993 Male 17 Hispanic High School or less First Whole BloodEnd Stage Renal Disease Mental Health Rehab. Dead, Other Death, W117009133548LRA RBC 11/13/2009 W11700913354800L 11/5/2009 650060304177 Male 52 White Master's or Prof. Degree Repeat Whole BloodCachexia Autopsy Performed

SFGH003 Male 61 Black Luekocytopenia, Unspecified Lhh Acute Medical Longterm Care W117009135232LRA2 RBC 11/16/2009 W11700913523200T 11/2/2009 650060372232 Male 31 White Master's or Prof. Degree Repeat 2RBCOpen Wound Buttock-Comp Lhh Bed Hold Other FacilityR/O Hiv Disease Medicine Acute Care Facility

SFGH007 Male 61 Asian Ac Osteomyelitis-Ankle Trauma Active W117009224115LRA1 RBC 11/1/2009 W11700922411500N 10/10/2009 650060191503 Male 24 White High School or less Repeat 2RBCAcute Renal Failure Nos Lhh Snf Rehab ActiveChronic Kidney Disease, Stage V

SFGH008 Female 63 Asian Disorder Bone & Cart Nos Orthopedics Rehab Facility W117009339905LRA RBC 11/11/2009 W117009339905009 10/29/2009 650060263725 Female 19 White High School or less Repeat Whole BloodFemale Breast Ca Nos Lhh Snf Rehab Routine Knee Replacement Status Discharge Home

SFGH009 Male 50 Hispanic Ac Respiratory Failure Family Medicine Rehab Facility W117009125577LRA RBC 11/8/2009 W11700912557700B 10/10/2009 650026346189 Male 35 Hispanic Bachelor's Degree Repeat Whole BloodR/O Hiv Disease Lhh Snf Rehab W117009224107LRA RBC 11/9/2009 W11700922410700N 10/10/2009 650060341853 Male 27 White High School or less Repeat Whole BloodSepsisButtock Cellulitis

SFGH010 Male 49 Asian Abn Rxn-Surgical Px Nec Urology Rehab Facility W117009124571LRA1 RBC 11/1/2009 W117009124571002 10/7/2009 650060255650 Male 29 Hispanic High School or less Repeat 2RBCAbnormal Glucose Nec Longterm Care W117009337849LRA2 RBC 11/1/2009 W11700933784900P 10/7/2009 650060369524 Male 30 White Some College/Tech.School First 2RBCAtrial Fibrillation W117009131270LRA RBC 11/2/2009 W117009131270007 10/28/2009 650060303614 Male 25 N/A High School or less Repeat Whole BloodAcute Renal Failure Nos W117009130360LRA RBC 11/3/2009 W11700913036000J 11/1/2009 650060372043 Male 43 White Bachelor's Degree First Whole BloodCerebral Embol W Infarct W117009134580LRA RBC 11/3/2009 W117009134580005 11/1/2009 650060305952 Male 41 Asian Master's or Prof. Degree Repeat Whole Blood

W117009222936LRA2 RBC 11/4/2009 W11700922293600I 10/10/2009 650060267910 Male 37 White Some College/Tech.School Repeat 2RBCW117009127098LRA1 RBC 11/5/2009 W117009127098009 10/13/2009 657000010800 Male 58 White Master's or Prof. Degree Repeat Apheresis

SFGH012 Male 66 Black Bronchus/Lung Ca Nec Neurology Acute Care Facility W117009133992LRA RBC 11/9/2009 W11700913399200I 11/7/2009 650060372892 Female 16 White High School or less First Whole BloodChr Blood Loss Anemia W117009135339LRA RBC 11/9/2009 W117009135339007 11/7/2009 650060372884 Female 28 White Bachelor's Degree First Whole Blood

SFGH014 Male 64 Hispanic Alc Dep Nec & Nos-Cont Medicine Routine W117009126916LRA RBC 11/7/2009 W11700912691600Q 10/8/2009 650060282969 Male 57 Asian Master's or Prof. Degree Repeat Whole BloodAlcohol Liver Cirrhosis Discharge Home W117009128984LRA RBC 11/7/2009 W117009128984007 10/10/2009 650060071034 Female 53 White Master's or Prof. Degree Repeat Whole Blood

SFGH00022Female 67 Black Abn Rxn-Artificial Impl Orthopedics Routine W117009222880LRA1 RBC 11/3/2009 W11700922288000I 10/6/2009 650060369345 Male 16 White High School or less First 2RBCMechan.Compl.Of Int.Orth. Dev Discharge Home W117009338294LRA RBC 11/3/2009 W11700933829400A 10/6/2009 650060096234 Male 28 White Some College/Tech.School Repeat Whole Blood

IRB, HIPAA and Honest Broker• UCSF CHR approval obtained with waiver of consent• Data use agreement with VAMC; MOU with SFGH pending• Use of UCSF CTSI MyResearch secure portal by the CCC to

maintain REDS-III data directories securelyUCSF CTSI offers “honest broker” service through its MyResearch

secure portal:• Holds identified data and translation keys in secure escrow. • Provides de-identified data to researchers. • Provides de-identification and re-identification services for

researchers.

Possible Recipient database analyses • Epidemiology of blood component transfusion:

• RBC, Platelets and Plasma – incidence, secular trends and outcomes

• Transfusion Reactions• Compare active surveillance (clinical study) and passive reporting; estimate

degree of underreporting using changes in vital signs or post transfusion interventions eg medications, chest xrays etc.

• Trauma• Epidemiology of transfusions, outcomes, risk factors for poor outcomes.

• Neurosurgery and neurologic injury• Identifying Predictors of Transfusion

• Extending Kaiser models to REDS-III recipient database for predicting transfusion of red cells, platelets or plasma

Status Report• First quarter 2013 data uploaded from UCSF-MC; VAMC and

SFGH uploads imminent pending admin approvals• Backfill additional quarters of data into 2014

Conclusions• REDS-III leverages the EMR to address important clinical

questions regarding the utilization and outcomes of blood transfusion

• The work involved is not trivial, and demands close interaction between programmers and content (medical) experts