In vitro quality parameters of whole blood-derived platelets pooled using two different platelet pooling sets and stored up to 7 days are similar.

BACKGROUND: Increasing the number of collections of whole blood-derived platelets (WBDP) and lengthening the allowable storage time may alleviate platelet (PLT) shortages. There is a need for new PLT pooling sets that can provide acceptable quality on Day 7 of storage. STUDY DESIGN AND METHODS: This pool-and-split study compared WBDP prepared using the platelet-rich plasma method with the novel IMUGARD WB PLT pooling set and a control pooling set. After pooling and filtration, PLT products were tested on Days 1, 5, and 7. Large volume delayed sampling (LVDS) cultures were taken on Day 2. RESULTS: The median postfiltration residual white blood cell (rWBC) content was 0.18 million per product (maximum 1.26 million; n = 69) with mean PLT recovery of 88.5 ± 2.8% for the new set and median 0.23 million (maximum 1.83 million) rWBC with 87.5 ± 2.5% recovery for the control. Day 5 mean pH22°C were 7.18 ± 0.12 and 7.13 ± 0.10 for the new and control set, respectively. Day 5 in vitro quality parameters were within 20% between the two pooling sets. The new set Day 7 pH22°C was acceptable (7.07 ± 0.17, 100% ≥ 6.3), and most parameters were within 20% of Day 5 values. CONCLUSION: WBDP quality for the new pooling set is acceptable across a battery of in vitro tests when stored up to 7 days and meets FDA regulatory criteria. The quality parameters were similar between the new pooling set and the control set on Day 5. This new set is compatible with LVDS.

Novel method for determining when a field-collected donor unit is sufficiently full.

BACKGROUND: Whole blood (WB) collections can occur downrange for immediate administration. An important aspect of these collections is determining when the unit is sufficiently full. This project tested a novel method for determining when a field collection is complete. METHODS: The amount of empty space at the top of WB units, destined to become LTOWB or separated into components, that were collected at blood centers or hospitals was measured by holding a WB unit off the ground and placing the top of a piece of string where the donor tubing entered the bag. The string was marked where it intersected the top of the column of blood in the bag and measured from the top. The WB units were also weighed. RESULTS: A total of 15 different bags, two of which were measured in two different filling volumes, from 15 hospitals or blood centers were measured and weighed. The most commonly used blood bag, Terumo Imuflex SP, had a median string length of 9 mm (range: 2-24 mm) and weighed a median of 565.1 g (range: 524.8-636.7 g). CONCLUSION: Pieces of string can be precut to the appropriate length depending on the type of bag before a mission where field WB collections might be required and a mark placed on the bag before the collection commences to indicate when the unit is full.

High versus low fixed-dose four factor-prothrombin complex concentrate for warfarin reversal in patients with intracranial hemorrhage.

BACKGROUND: Four-factor prothrombin complex concentrate 4F-PCC is the standard of care for warfarin reversal in patients with major bleed or requiring urgent surgery. Although the 4F-PCC dose is weight and international normalized ratio (INR) based, for practical purposes, a fixed-dose approach has been explored, especially for rapid reversal. We report our experience using two different fixed-dose 4F-PCC for warfarin reversal in patients presenting with intracranial hemorrhage (ICH). STUDY DESIGN AND METHODS: We completed a retrospective chart review comparing high (4000 units) versus low (2000 units) dose 4F-PCC by evaluating patient characteristics, laboratory data, and pre-and post-4F-PCC brain imaging. RESULTS: There was no significant difference between patient characteristics or INR correction (≤1.5) between the two groups. Eighty percent (12/15) of patients who received the low dose 4F-PCC had either improved or stable brain imaging as compared to 88% (14/16) of patients who received the high dose PCC. When the eight patients (4 from each arm of the study) who required neurosurgery were excluded, only two patients in each arm had worse imaging after 4F-PCC. CONCLUSION: There was no significant difference between the INR correction and the brain imaging changes in patients with an ICH who received either the high or the low fixed-dose 4F-PCC for warfarin reversal.

Immune checkpoint inhibitor toxicity: A new indication for therapeutic plasma exchange?

Novel immune-modulating anticancer drugs are being used with increasing frequency. With increased use, there are more frequent cases of toxicities caused by these drugs, termed immune-related adverse events (irAEs). We present a case in which we successfully treated a case of severe, steroid-refractory, nivolumab-induced myocarditis with therapeutic plasma exchange (TPE). Nivolumab is an immune checkpoint inhibitor (ICI) which blocks programmed death receptor-1 (PD-1). This blockade allows for enhanced T-cell function and increased anti-tumor response. The patient presented with signs and symptoms of heart failure and was found to have a significantly depressed cardiac ejection fraction. Over the course of her five TPE procedures, she improved clinically and was discharged home with improved left ventricular ejection function. This case suggests an emerging role of TPE in the management of severe ICI-induced toxicity, such as myocarditis.

Reproducible evaluation of tumor-infiltrating lymphocytes (TILs) using the recommendations of International TILs Working Group 2014.

Tumor infiltrating lymphocytes (TILs) in breast cancer play an important role in predicting the outcome of breast cancer. The goal of our current study is to investigate the consistency and reproducibility of the recommendations published by the International TILs Working Group 2014 among pathology trainees and pathologists. Hematoxylin & Eosin (H&E) slides from 129 breast cancer cases (one slide each) from 2009 to 2014 were evaluated. Each case was blindly and independently reviewed by two observers following the International TILs Working Group 2014 recommendations. Three pathology trainees (PGY2, PGY3 and PGY4) and three pathologists (2 general pathologists and 1 breast pathologist) were involved in this study. Of the 129 cases, 10 (10/129, 7.8%) cases had TILs >50%, 90 (90/129, 69.8%) cases had <10% of TILs, and 29 (29/129, 22.4%) cases had TILs ranging from 10 to 50%. Our results showed that in 104 cases (104/129, 80.6%) the TILs percentage was identical between the 2 observers. In 18 cases (18/129, 14%), the difference between the two observers was by 10% and in 7 cases (7/129, 5.4%) there was a difference of 20% or more. The inter-observer kappa value was 0.776 between two observers, and the kappa score improved to 0.86 if using the 3 categoric groups (<10%, 10-50%, and >50%). Our study showed that the recommendations and instructions for TILs evaluation by the International TILs Working Group 2014 were sufficiently detailed to be applied for TILs evaluation in breast cancer.

PIFA PLUSS P4 Assay for Screening of Heparin-Induced Thrombocytopenia.

BACKGROUND: The PIFA PLUSS PF4 Rapid Assay (PIFA) is a rapid screening test used for the diagnosis of heparin-induced thrombocytopenia (HIT). OBJECTIVE: To determine the usefulness of this assay as a screening method in our institution. METHODS: A total of 159 specimens from patients with suspected HIT were included in our study. We simultaneously performed PIFA assay and confirmatory polyspecific enzyme-linked immunosorbent assay (ELISA). We subjected most of the specimens with false-negative results to serotonin release assay (SRA). RESULTS: The initial sensitivity and specificity of the PIFA assay were calculated as 27.3% and 71.5%, respectively. A total of 12 of 16 false-negative results were further tested using the SRA method. The revised sensitivity and specificity were 50.0% and 73.5%, respectively. CONCLUSIONS: Despite its appealing feature of yielding rapid results, the PIFA assay is inadequate as a sole screening test for HIT because of its high probability of missing many true cases of HIT.

New Onset Iron Deficiency Anemia in Chronic Therapeutic Plasma Exchange Patients.

Iron deficiency has been recognized as a complication of whole blood and red blood cell apheresis donation; however, the effect of chronic therapeutic plasma exchange (TPE) on patient iron status is largely unknown. We performed a retrospective review of all patients undergoing chronic TPE (at least 1 TPE every 2 weeks for 1 month with a minimum of 8 TPE treatments) with 5% albumin at our institution from 2011 to 2016. After review of serum iron level and iron saturation status, six out of ten (60%) of the patients who meet the study criteria were found to develop iron deficiency anemia (IDA). This data supports the notion that chronic TPE, especially when combined with additional risk factors, can increase the risk of IDA.

Can Tranexamic Acid Reduce Blood Loss during Major Cardiac Surgery? A Pilot Study.

We examined the effectiveness of tranexamic acid in preventing intraoperative blood loss during major cardiac surgery. Out of initial 81 patients undergoing major cardiac surgery (both coronary artery bypass and valve repair procedures) at our teaching hospital, sixty-seven patients were selected for this study. We compared estimated blood loss, decrease in percent hemoglobin and hematocrit following surgery between two groups of patients (none of them received any blood product during surgery), one group receiving no tranexamic acid (n=17) and another group receiving tranexamic acid (n=25). In the second study, we combined these patients with patients receiving modest amounts of blood products (1-2 unit) and compared these parameters between two groups of patients (25 patients received no tranexamic acid, 42 patients received tranexamic acid). In patients who received no blood product during surgery, those who received no tranexamic acid showed statistically significant (independent t-test two tailed at p<0.05) reduced estimated blood loss (mean: 713.5 mL, SD: 351.6, n=17) compared to those who received tranexamic acid (mean: 987.2 mL, SD: 459.9, n=25). We observed similar results when the patients receiving no blood products and patients receiving modest amount of blood products were combined based on the use of tranexamic acid or not. No statistically significant difference was observed in percent reduced hemoglobin or hematocrit following surgery in any group of patients. We conclude that intraoperative antifibrinolytic therapy with tranexamic acid does not reduce intraoperative blood loss during major cardiac surgery which contradicts popular belief.

Coccidioidomycosis Presented as a Pelvic Mass in an Otherwise Healthy Female.

We present a case of a 32 year old female with a past medical history of hypertension who presented with several years of chronic back pain and was ultimately diagnosed with isolated pelvic coccidioidomycosis. She was initially seen by gynecologic oncology for assessment of possible metastatic cancer by image study, but a cytopathologic diagnosis of coccidioidomycosis lead to a cancellation of the planned surgery and extensive antifungal treatment managed by the infectious disease team. She had no known previous pulmonary disease or immunodeficiency. Pelvic coccidioidomycosis without known pulmonary disease is very rare, and disseminated infection typically only occurs in those who are severely immunocompromised. Our case presented with several years of back pain and a pelvic mass mistaken for possible malignancy by image study.