TASSO Study
Principal Investigators: Ajit Limaye, MD, Andy Hoofnagle, MD PhD and Cynthia Fisher, MD MPH
Study Design: Investigator Initiated
The Tasso Device is an investigational self-collection capillary blood collection device. Currently, clinical blood collection is done by venipuncture, however the Tasso device collects capillary blood. The intent is to allow patients to collect blood samples easily at home without any additional directions from a phlebotomist.
Background/Rationale
Frequent blood monitoring is standard of practice for all solid organ transplant (SOT) patients for assessment of immunosuppressant levels, detection of viral infections, and toxicity monitoring. This is accomplished through in-person phlebotomy using venipuncture, which has many disadvantages, including: need for in-person visit, pain associated with venipuncture, potential exposures to nosocomial infections (e.g. COVID-19).
The use of blood self-collection strategies could potentially address some of these disadvantages of in-person phlebotomy by allowing for home self-collection and subsequent transport to clinical laboratories for analysis.
New blood self-collection devices such as the Tasso capillary blood collection device show promise based on preliminary studies demonstrating: comparability with standard venipuncture blood for several important analytes, patient acceptability and ease of use, and safety.
We propose to assess the safety, patient acceptability, and accuracy of Tasso-collected capillary blood compared to standard venipuncture among SOT recipients who are undergoing clinically-indicated phlebotomy as part of routine post-transplant care.
This device has not been approved for sale or use by the US Food and Drug Administration (FDA). It’s use is experimental in the study, which is investigator-initiated and not sponsored by TASSO, Inc.
Study Design
Research coordinators identify SOT recipients who meet criteria and who are scheduled for clinical blood draw at University of Washington Medical Center (UWMC) through the electronic scheduling system and electronic Medical Record database (EMR). These patients are then contacted via phone/email to introduce the study, if interested verbal consent will be obtained and research coordinators meet patients at their scheduled phlebotomy/clinical blood draw visit.
Primary Objectives
Assess the concordance of results for selected blood analytes from on-site (semi-supervised) and at-home self-collected (non-supervised) Tasso device-collected capillary blood with those obtained from the gold standard venipuncture method.
Assess the feasibility of blood self-collection with the Tasso Devices.
Assess the acceptability of blood self-collection with the Tasso Devices.
Status: The study is currently enrolling with more than 25 patients so far
Collection via Venipuncture
Transplant patients who are seropositive for cytomegalovirus (CMV) will generally have lab orders by their care team to test and monitor CMV viral load that will be collected via venipuncture. CMV viral load will be viewable on their patient chart once results are released.
Collection vis TASSO Device
On the day of a transplant patient’s clinical draw, capillary blood will be collected using the TASSO device in the upper arm shortly after blood collection via venipuncture. Samples will be tested for CMV viral load, the same test that is done on the clinical draw.