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Patient 1
LOT NUMBER AND EXPIRY INFORMATION ARE NOT AVAILABLE AT THIS TIME. INVESTIGATION: PER THE ARTICLE, "ALTHOUGH A SIGNIFICANT NUMBER OF PATIENTS EXPERIENCED MILD TO MODERATE COMPLICATIONS RELATED MOSTLY TO HYPOCALCEMIA AND ALLERGIC REACTIONS, TPE-RELATED MORTALITY OR SEVERE COMPLICATIONS ARE INFREQUENT, AND TPE IS A RELATIVELY SAFE THERAPY." THIS WAS A RETROSPECTIVE STUDY IN A MULTI-INSTITUTIONAL COHORT OF 109 PATIENTS WITH ITTP BETWEEN 2004 AND 2017. THIS STUDY INCLUDED PATIENTS PRESENTING BETWEEN JANUARY 8, 2004, AND APRIL 26, 2017, WITH CONFIRMED ITTP AT FOUR LARGE ACADEMIC MEDICAL CENTERS IN BOSTON. VENOUS ACCESS WAS OFTEN OBTAINED VIA TEMPORARY DUAL-LUMEN APHERESIS CATHETERS PLACED IN THE INTERNAL JUGULAR OR, LESS COMMONLY, THE FEMORAL VEIN. PROCEDURES WERE PERFORMED USING AN APHERESIS MACHINE (COBE SPECTRA OR OPTIA, TERUMO BCT). BOTH STANDARD (NOT VIRUS INACTIVATED) FRESH FROZEN PLASMA AND CRYOPRECIPITATE-POOR PLASMA WERE USED AS REPLACEMENT FLUID, AS DESIGNATED BY THE TREATING PHYSICIAN. ANTICOAGULANT CITRATE DEXTROSE A SOLUTION WAS ROUTINELY INFUSED AT 1:10 INLET RATIO FOR ANTICOAGULATION. CALCIUM GLUCONATE WAS INFUSED CONTINUOUSLY THROUGHOUT EACH PROCEDURE, AND THE INFUSION RATE WAS INCREASED IN THE SETTING OF SYMPTOMATIC HYPOCALCEMIA. IONIZED CALCIUM WAS NOT ROUTINELY MEASURED WHEN SYMPTOMS OF HYPOCALCEMIA WERE REPORTED. MOST PATIENTS UNDERWENT DAILY, ONE PLASMA-VOLUME EXCHANGES. THEY IDENTIFIED 124 PATIENTS WHO PRESENTED WITH ACUTE ITTP BETWEEN JANUARY 8, 2004, AND APRIL 26, 2017, AT ONE OF THE SIX PARTICIPATING INSTITUTIONS. THE MAJORITY OF PATIENTS WERE TREATED AT HOSPITALS WITHIN THE HARVARD TMA RESEARCH COLLABORATIVE (TABLE 1). OVERALL, 104 PATIENTS WERE ENROLLED DURING THEIR FIRST EPISODE OF ACUTE ITTP, WHILE 20 WERE ENROLLED DURING A RELAPSED PRESENTATION. THE MEDIAN (INTERQUARTILE RANGE [IQR]) AGE OF OUR PATIENT COHORT WAS 42 YEARS (31-52), 69% WERE FEMALE, AND 42% WERE NON-CAUCASIAN. THE MEDIAN (IQR) PLATELET COUNT AT PRESENTATION WAS 16,000 (10,000-22,000) PER MICROLITER, AND THE MEDIAN (IQR) ADAMTS13 ACTIVITY LEVEL WAS 0% (0%-0%). THE VAST MAJORITY OF PATIENTS WERE TREATED DURING THE INDEX EVENT (DEFINED AS THE EVENT THAT LED TO THEIR ENROLLMENT IN OUR STUDY). COMPLICATIONS OF TPE WERE ANALYZED IN A SUBSET OF THIS COHORT (74 PATIENTS REPRESENTING 101 TREATMENT COURSES CONSISTING OF A TOTAL OF 1497 PROCEDURES.) COMPLICATIONS WERE CATEGORIZED AS ALLERGIC, MODERATE HYPOCALCEMIA, CATHETER-RELATED (INFECTIOUS AND NONINFECTIOUS), NON?CATHETER-ASSOCIATED INFECTIOUS, AND NONALLERGIC TRANSFUSION REACTIONS. ALLERGIC REACTIONS WERE CONSIDERED MILD IF LIMITED TO URTICARIA AND TREATED WITH A SINGLE DOSE OF ANTIHISTAMINE. ALLERGIC REACTIONS WITH SYMPTOMS BEYOND ISOLATED URTICARIA OR REQUIRING ADDITIONAL TREATMENT WITH TYPE 2 HISTAMINE RECEPTOR BLOCKERS OR STEROIDS WERE CONSIDERED MODERATE, AND ANY REACTION REQUIRING EPINEPHRINE WAS CONSIDERED SEVERE (ANAPHYLAXIS). HYPOCALCEMIC REACTIONS WERE CONSIDERED MODERATE IF PATIENTS HAD SYMPTOMS IN ADDITION TO TINGLING, INCLUDING MUSCLE CRAMPS, NAUSEA, VOMITING, HYPOTENSION, OR CHEST PAIN. SEVENTEEN PATIENTS WERE TREATED WITH TWO OR MORE COURSES OF TPE. FIFTY-SIX OF 74 PATIENTS (76%) EXPERIENCED AT LEAST ONE COMPLICATION FROM TPE. MOST FREQUENT WERE MILD URTICARIAL REACTIONS REQUIRING A SINGLE DOSE OF DIPHENHYDRAMINE, WHICH OCCURRED IN 34 OF 101 COURSES OF TPE (34%). MORE SIGNIFICANT ALLERGIC REACTIONS REQUIRING STEROIDS AND/OR TYPE 2 HISTAMINE RECEPTOR BLOCKERS OCCURRED DURING 15 OF 101 COURSES (15%), AND 4 OF 101 COURSES (4%) RESULTED IN ANAPHYLAXIS REQUIRING TREATMENT WITH EPINEPHRINE. OTHER COMPLICATIONS INCLUDED MODERATE HYPOCALCEMIA IN 9 OF 101 COURSES (9%) AND CATHETER RELATED COMPLICATIONS IN 12 OF 101 COURSES (12%), INCLUDING TWO LINE-ASSOCIATED INFECTIONS, ONE THROMBOTIC COMPLICATION REQUIRING SYSTEMIC ANTICOAGULATION, TWO BLEEDING COMPLICATIONS, SIX CATHETER FAILURES RELATED TO LINE THROMBOSIS OR PLACEMENT ERROR, AND ONE LINE-INDUCED SUPRAVENTRICULAR TACHYCARDIA. OVERALL, 7 OF 101 (6.9%) TREATMENT COURSES HAD AT LEAST ONE SEVERE ADVERSE EVENT, DEFINED AS THE SUM OF ANAPHYLAXIS, LINE ASSOCIATED INFECTIONS, AND THROMBOSIS REQUIRING SYSTEMIC ANTICOAGULATION. THERE WERE NO SUSPECTED OR CONFIRMED CASES OF TRANSFUSION-RELATED ACUTE LUNG INJURY. . THE AUTHORS HAD HYPOTHESIZED THAT REFRACTORY DISEASE, AS DEFINED BY A HIGH NUMBER OF TPE TREATMENTS OR LONG DURATION OF HOSPITALIZATION, MIGHT BE ASSOCIATED WITH MORTALITY. HOWEVER, THEY FOUND THAT NEITHER EXTREMES IN LENGTH OF HOSPITAL STAY NOR NUMBER OF TPE PROCEDURES WAS PREDICTIVE OF MORTALITY. THE MAJORITY OF DEATHS (5/8) WERE ASSOCIATED WITH DELAY IN THE DIAGNOSIS OF ITTP OR INITIATION OF TPE OR PRESENTATION TO THE HOSPITAL IN A MORIBUND STATE. SEE ATTACHED ARTICLE FOR FULL STUDY DETAILS. ARTICLE CITATION: COLLING, M., ET. AL. 2020. DEATHS AND COMPLICATIONS ASSOCIATED WITH THE MANAGEMENT OF ACUTE IMMUNE THROMBOTIC THROMBOCYTOPENIC PURPURA. TRANSFUSION 2020;9999;1?6. INVESTIGATION IS IN PROCESS. A FOLLOW-UP R...