Obtaining Samples from Human Subjects to Facilitate Basic, Translational and Clinical Research

Clinical Center

Investigators

Linked publications & trials

Abstract

This protocol defines in general terms the purposes for which blood, urine and ultrafiltrate will be collected from adult research subjects and healthy volunteers by members of the NIH Clinical Center's Critical Care Medicine Department and collaborating institutions and establishes general conditions under which sampling will be performed. Blood drawing will be consistent with NIH Clinical Center guidelines. The Critical Care Medicine Department and our associated investigators are involved in the development of new translational research protocols and maintenance of existing IRB approved research protocols. This protocol will support the establishment of new translational research protocols through assay development and provide information to guide the effective implementation of new protocols as well as maintain efficiency in operations of existing protocols. The protocol was approved by the National Heart, Lung, and Blood Institutional Review Board (recently changed to General Medicine 1 IRB) in August 2017. Over the course of the protocol, research subjects have provided blood samples for DNA gene sequencing for Pulmonary Arterial Hypertension (PAH), immunophenotyping for relapsing polychondritis, isolation of B cells for flow cytometry, cell free DNA isolation for PAH, inflammatory marker studies, thrombelastography (TEG) and other blood markers of coagulation and fibrinolysis, RNA isolation for sequencing, vitamin C levels, PBMCs isolated from whole blood for reprogramming and generation of induced pluripotent stem cell (iPSC) lines, and to isolate cells and plasma to either 1) serve as a comparator for COVID-19 patients or 2) perform in-vitro stimulations to study several COVID-19 molecular mechanisms. During the current reporting period 4 subjects were newly enrolled (3 healthy volunteers and 1 patient). Over the life of the protocol (as of September 2021) a total of 93 subjects have enrolled (47 healthy volunteers and 46 patients). Over the current reporting period 113 blood samples were provided to investigators and over the life of the protocol 270 samples have been provided to investigators. The following abstract have been presented using samples obtained from this protocol. Brusca SB, Elinoff JM, Jang MK, Demirkale CY, Valantine HA, Solomon MA, and Agbor-Enoh ST. Plasma Cell-free DNA as a Novel Marker of Disease Severity in Pulmonary Arterial Hypertension. American College of Cardiology 68thAnnual Scientific Session, J Am Coll Cardiol, 73(9, S1): S1897, 2019. Lu M, Blaine K, Cullinane A, Hall C, Dulau-Florea ,A, Sun J, Chenwi H, Graninger G, Harper B, Elinoff JM, and Solomon MA. Pulmonary Arterial Hypertension Patients Display Normal Kinetics of Clot Formation. American Heart Association Scientific Sessions, 140:A10714, 2019 The following papers have been published using samples obtained from this protocol. Lu M, Blaine KP, Cuillinane A, Hall C, Dulau-Florea A, Sun J, Graninger GM, Harper BJ, Brusca SB, Elinoff JM, and Solomon MA. Pulmonary Arterial Hypertension Patients Display Normal Kinetics of Clot Formation. Pulm Circ, 11(3): 1-9, 2021 Strich RJ, Ramos-Benitez MJ, Randazzo D, Stein SR, Babyak A, Davey RT, Suffredini AF, Childs RW, Chertow DS. Fostamatinib Inhibits Neutrophils Extracellular Traps Induced by COVID-19 Patient Plasma: A Potential Therapeutic. The Journal of Infectious Diseases, 223 (6): 981984, 2021.