Head injury serum markers for assessing response to trauma: Design of the HeadSMART study.

BACKGROUND: Accurate diagnosis and risk stratification of traumatic brain injury (TBI) at time of presentation remains a clinical challenge. The Head Injury Serum Markers for Assessing Response to Trauma study (HeadSMART) aims to examine blood-based biomarkers for diagnosing and determining prognosis in TBI. METHODS: HeadSMART is a 6-month prospective cohort study comparing emergency department patients evaluated for TBI (exposure group) to (1) emergency department patients evaluated for traumatic injury without head trauma and (2) healthy persons. Study methods and characteristics of the first 300 exposure participants are discussed. RESULTS: Of the first 300 participants in the exposure arm, 70% met the American Congress of Rehabilitation Medicine criteria for TBI, with the majority (80.1%) classified as mild TBI. The majority of subjects in the exposure arm had Glasgow Coma Scale scores of 13-15 (98.0%), normal head computed tomography (81.3%) and no prior history of concussion (71.7%). CONCLUSION: With systematic phenotyping, HeadSMART will facilitate diagnosis and risk-stratification of the heterogeneous group of individuals currently diagnosed with TBI.

SLE-key(®) rule-out serologic test for excluding the diagnosis of systemic lupus erythematosus: Developing the ImmunArray iCHIP(®).

We describe here the development, verification and validation of the SLE-key(®) rule-out test for a definitive rule-out of a diagnosis of systemic lupus erythematosus (SLE). The test uses the proprietary iCHIP(®) micro-array technology platform (Fattal et al., 2010) to identify discriminating patterns of circulating autoantibodies among SLE patients compared with self-declared healthy individuals. Given the challenges associated with the diagnosis of SLE and the healthcare costs of delayed diagnosis and misdiagnosis, a definitive rule-out test can provide significant clinical benefits to patients and potentially major cost savings to healthcare systems.

Evaluation of renal function in transplantation.

Kidney dysfunction causes a myriad of adverse influences on posttransplant outcomes necessitating accurate assessment of kidney function for patient management. This evaluation assists in guiding treatment decisions, with the ultimate aim of allaying renal function decline. In clinical practice, renal function is typically estimated from serum creatinine levels, creatinine-based estimation equations or creatinine clearance; however, each of these methods has demonstrated limitations when used in the kidney transplant setting. Equally important is the emerging recognition of the incidence and impact of kidney dysfunction in recipients of nonrenal solid organ transplantation. The performance of commonly used estimation equations and methods for measuring kidney function in renal and liver transplant patients are overviewed here along with their potential roles in clinical transplantation.

The nondirected living donor program: a model for cooperative donation, recovery and allocation of living donor kidneys.

We describe an altruistic nondirected (ND) and live donor/deceased donor list exchange (LE) donor program administered by an organ procurement organization (OPO) in the Washington, DC area. Screening eliminated 25 donors (17 NE; 8 LE) from the 97 donor applications (62 ND; 35 LE) completed. Twenty-one donors (16 ND; 5 LE) failed to follow through with the psychiatric evaluation, which eliminated 13 donors (9 ND; 4 LE). Two donors dropped out and 12 (9 ND; 3 LE) were medically unsuitable after final clinical evaluation. Twenty donor procedures were performed (10 ND; 10 LE) with four pending (2 ND; 2 LE). This resulted in a modest 3-5% increase in the OPO-procured kidney organ pool. The average cold ischemia time of the grafts not transported between transplant centers was 205 +/- 66 min compared with 243 +/- 48 min for transported grafts. With no documented adverse outcomes, donors had a hospital stay of length 2.9 days and at home recuperation of 12.3 days. Three- and 6-month creatinines were 1.44 +/- 1.36 and 1.68 +/- 0.61 for grafts not transported between transplant centers, and 1.6 +/- 0.27 and 1.6 +/- 0.44 for transported grafts. An OPO-administered altruistic donor program can serve as a model for cooperative donation, recovery and allocation of living donor kidneys.

Effect of donor factors on early graft survival in adult cadaveric renal transplantation.

Previous studies of the effect of donor factors on renal transplant outcomes have not tested the role of recipient body mass index, donor/recipient weight ratios and age matching, and other factors. We analyzed 20,309 adult (age 16 or older) recipients having solitary cadaveric renal transplants from adult donors from 1 July 1994 to 30 June 1998 in an historical cohort study (the 2000 United States Renal Data System) of death censored graft loss by the Cox proportional hazards models, which corrected for characteristics thought to affect outcomes. The only independently significant findings in Cox Regression analysis were a high donor/ recipient age ratio (> or = 1.10, e.g. a 55-year-old donor given to a recipient age 50years or younger, adjusted hazard ratio (AHR) 3.22, 95% confidence interval (CI) 2.36-4.39) and African American donor kidneys (AHR 1.64, 95% CI, 1.24-2.17). African American recipients and older donors were not at independently increased risk of graft failure in this model. Among donor factors, older donor kidneys given to younger recipients and donor African American kidneys were independently associated with graft loss in recipients of cadaver kidneys. The task for the transplant community should be to find the best means for managing all donor organs without discouraging organ donation.