# Presentation: 766692

## "CJD Lookback Study"(Research Study to Assess the Risk of Blood Borne Transmission of CJD)

**American Red Cross Blood Services**

- TSEAC
- October 14, 2004

***Roger Y. Dodd, PhD***
***Presented by Peter L. Page, MD***

## Creutzfeldt-Jakob disease (CJD)

- Classic Creutzfeldt-Jakob disease (CJD)
- a rapidly fatal degenerative disorder of the central nervous system
- characterized by cerebral spongiform changes
- caused by a distinct group of agents called prions
- In 1996, a new variant of CJD (vCJD) described in the UK
- Possible transmission of vCJD by blood transfusion reported from UK in 2003
- Second possible case of vCJD transmission via transfusion, reported from UK in July 2004

**Notes:**
Line 1: The CDC prefers that we refer to this as “Classic” (not “classical”) CJD.

## CJD Lookback Study 

- Designed in 1994 by ARC and CDC and implemented in 1995
- To assess the risk of transmission of CJD by whole blood and blood components
- In 1997, the coordinating responsibility for the study transferred to the former NBDRC of AABB
- Late 2003, the study management returned to ARC
- September 2004, a cooperative agreement on the study reached between CDC and ARC for the next 5 years

**Notes:**
Bullet 2:  should read ”whole blood and blood components”.  Older cases did receive WB.

## Methods

- Upon a U.S. blood center learning that a blood donor has been diagnosed with CJD, recipients of whole blood and blood components from prior donations are identified (not notified*).
- Each year since 1995, the names of these recipients are checked against the NDI*Plus* (National Center for Health Statistics) for multiple causes of death.

- *FDA new guidance

**Notes:**
The January 2002 Guidance from the FDA states:
“It may be appropriate to identify blood components for transfusion prepared from prior
collections from any donor found to have CJD, vCJD, suspected vCJD, risk factors for CJD, or if
withdrawal is recommended in cases under investigation for vCJD (CJD diagnosis and age <55).
In those situations, consignee notification could enable the consignee to inform the physician, or
other qualified personnel responsible for the care of the recipients, so that recipient tracing and
medically appropriate notification and counseling may be performed at the discretion of health
care providers.”

## Methods

**Both CDC IRB and ARC IRB approved the study**
**Changes have been made to the study protocol following the reporting of possible transmission of vCJD through transfusion and FDA’s new guidance**
- no notification necessary for this study
- medically appropriate notification and counseling may be performed at the discretion of health care providers
**Both CDC IRB and ARC IRB will be consulted when**
- a vCJD should occur in the US,
- a test becomes available or
- classic CJD should be associated with blood transmission.

**Notes:**
The January 2002 Guidance from the FDA states:
“It may be appropriate to identify blood components for transfusion prepared from prior
collections from any donor found to have CJD, vCJD, suspected vCJD, risk factors for CJD, or if
withdrawal is recommended in cases under investigation for vCJD (CJD diagnosis and age <55).
In those situations, consignee notification could enable the consignee to inform the physician, or
other qualified personnel responsible for the care of the recipients, so that recipient tracing and
medically appropriate notification and counseling may be performed at the discretion of health
care providers.”

## Results

**Enrollment as of June 2004**
**28 donors (CJD patients)**
**368 recipients of blood**
**102 alive (as of February 2003)**
**241 deceased**
**	****0****	****	****CJD**
**	****240  ****	****not CJD**
**	****1****	****	****pending**
**25 being investigated**

**Notes:**
As of 9/22/03, there were 26 “former” donors in the study.  Didn’t you say there have been 2 new cases since then?
There were a total of 342 recipients of whom 101 were alive and 241 were deceased.  My copy of the database doesn’t show any pending at that time.

## Results

**Post transfusion survival in person-years**
**Alive****	****	****966**
**Deceased****	****430**
**Total****	****	****1396**

**Notes:**
The results as of 2003.  No death index search conducted yet in 2004.

## Results

**Number of Long Term (>= 5 years) Survivors**
**# years****	****Living****	****Deceased****	****Total**
**after txn**
**>=5****	****	****84****	****	****32****	****	****116**
**5-10****	****	****47****	****	****25****	****	****72**
**11-15****	****	****24****	****	****3****	****	****27**
**16-20****	****	****10****	****	****3****	****	****13**
**21+****	****	****3****	****	****1****	****	****4**

**Notes:**
Long-term is defined as greater than or equal to 5 years post-transfusion survival.

The results as of 2003.  No death index search conducted yet in 2004.

## Summary

**No cases of CJD have occurred in 342 recipients of whole blood and blood component from donors who subsequently developed CJD, representing nearly 1,400 person-years of follow up.**
**Long term follow up of survivors will allow for more accurate estimate of the risk, if any, of transmission of CJD by blood components.**

**Notes:**
FYI the LFOs are primarily folks who were travelers from another country or students who left the US.  Can’t track anyone not in US.

## Contact Information

**When a CJD patient has been a volunteer blood donor, family members should contact the collecting blood center.**
**Blood centers learning of a blood donor having developed CJD are encouraged to participate in the study by contacting:**
**301 738-0495 fax**
**Karen Fujii, 301 738-0774 phone, fujiik@usa.redcross.org**
**Edward Notari, 301 738-0646, notarie@usa.redcross.org**
**Shimian Zou, PhD, 301 738-0644, zous@usa.redcross.org**

**Notes:**
Bullet 1: I would say “should” instead of “may”.  Blood centers should encourage this notification.

## Acknowledgment

**Marian T. Sullivan, MS, MPH: **currently with Research Triangle Institute
**CDC: **co-investigator (Dr. Larry Schonberger) and funding support
**Blood Regions/Centers:** support from many ARC Blood Services Regions and non-ARC blood centers including the military blood program
**ARC Staff: **Karen Fujii, Edward Notari, Shimian Zou

**Notes:**
Marian T. Sullivan MS, MPH
Research Triangle Institute