In 2005 the National Audit Office published figures that revealed nearly a million (974 000) ‘incidents’ or ‘near misses’ regarding patient safety had been recorded in England over the previous year. A total of 2181 later proved fatal. These incidents included errors in drug dose calculations, administering drugs at the wrong rate or to the wrong patient. The nursing profession, along with doctors, surgeons and every other member of the healthcare team must understand their role in these mistakes. This article considers how standardizing equipment used by clinical staff and enhancing best practice with evidence can significantly reduce medical errors and allow clinical staff more time with their patients.

2004-11-16·Blood

Antibody Formation to S-303-Treated RBCS in the Setting of Chronic RBC Transfusion.

作者: Conlan, Maureen G. ; Garratty, George ; Wages, David ; Corash, Laurence ; Wood, Lindsey ; Labotka, Richard J. ; Sloan, Steven R. ; Stassinopoulos, Adonis

AbstractBackground : S-303 treatment (200 μM S-303 and 2 mM glutathione) has been shown to inactivate viruses, bacteria, protozoa and leukocytes in RBC concentrates. S-303-treated RBCs (SRBC) have comparable in vitro parameters to untreated conventional RBCs (CRBC) over 42 days (d) of storage. Three Phase I trials in healthy human subjects showed recovery and life span of 35 d old autologous S-303 RBC were comparable to that for CRBC without detectable antibody (Ab) formation. During the course of a Phase III trial for patients (pts) in chronic transfusion (txn) programs receiving repeated SRBC txn, 2 pts developed asymptomatic anti-SRBC Ab, leading to trial termination.Methods : A randomized, controlled, double-blinded, crossover design, non-inferiority trial of SRBC in pts with thalassemia (thal) or sickle cell anemia (SSA) was conducted. Fifty pts were to receive a course (≥5 months or ≥6 txn) of SRBC or CRBC with crossover to the other arm. The frequency and number of RBC units per txn and target hemoglobin (Hb) were at physician discretion. The primary endpoint was Hb txed per kg body weight per d. Secondary endpoints were: time between txn, pre-txn Hb, number of RBC units txed, Ab formation, and adverse events (AEs). Routine DAT and IAT with RBC panels, and cross match with IAT to SRBC (and to the pre-S-303 treatment segment if positive to SRBC), were performed at trial sites prior to each txn. Following detection of positive cross match to SRBC in 2 pts, all pre-txn samples from all pts were tested by polyethylene glycol (PEG) SRBC cross match with IAT at a reference lab. Post study termination, pts had monthly follow-up (for up to 6 months) for AEs and repeated SRBC PEG cross match IAT.Results : The trial was terminated after 26 pts received ≥1 txn when 2 asymptomatic pts in the SRBC arm developed positive (+) pre-txn IAT cross matches with SRBC but not the same RBC unit pre-S-303 treatment (SRBC Ab). No pt completed the trial; 69% started the 1st period only and 31% crossed over to the 2nd period. 17 pts had ≥1 SRBC txn. Neither pt with (+) cross matches had clinical evidence of significantly reduced RBC survival. Hapten inhibition assays showed inhibition by S-303 derivatives but not glutathione used in the treatment process; a monocyte monolayer RBC phagocytic assay was negative with pt sera, suggesting these Ab were not likely clinically significant. Six-month follow-up of all txed pts did not reveal additional SRBC Ab or AEs. No Ab to SRBC were detected in a companion Phase III trial of SRBC txn for pts undergoing cardiac surgery supported with SRBC txn for up to 7 d.Conclusions : Two of 17 pts with exposure to SRBC in chronic txn programs developed Ab to SRBC after txn with SRBC. These Ab did not appear to result in decreased RBC survival (e.g., hemolysis), AEs, autoantibody formation, or Ab formation to RBC antigens. None of 74 pts txed with SRBC for up to 7 d to treat anemia of cardiac surgery developed SRBC Ab. A modified S-303 treatment process to reduce immunogenicity has been developed.Patients With Antibodies to S-303 RBCPatient 1 Patient 2 Age (yr) 3 13 Sex F M Diagnosis Thal SSA Time on study (d) 139 58 AEs Splenomegaly Pt. blood type AB+ A+ DAT/IAT (allo-Ab panel RBC) −/− −/− No. SRBC txn/units before (+) crossmatch 5/10 1/1 IAT reaction (LISS/PEG) against SRBC 2+/3+ 3+/2+ Titer of (+) sera against SRBC 2 8

2004-11-16·Blood

Transfusion of S-303 Treated RBCs To Treat Acute Anemia during or Following Cardiac Surgery: Results of a Phase III Trial.

作者: Wood, Lindsey ; Spotnitz, William D. ; Conlan, Maureen G. ; Wages, David ; Mintz, Paul D. ; McCullough, Jeffrey ; Benjamin, Richard J. ; Snyder, Edward L. ; Corash, Laurence ; Lin, Jin-Sying ; Houghton, Jaime

AbstractBackground : The FRALE compound, S-303, effectively inactivates contaminating pathogens in RBC concentrates. Phase I trials in healthy subjects showed recovery of S-303-treated RBCs (SRBC) stored for 35 days (d) to be comparable to conventional RBCs (CRBC). Phase III trials were initiated to evaluate SRBC for transfusion (tx) support of acute anemia in cardiac surgery and of chronic anemia for sickle cell anemia or thalassemia.Methods : A randomized, controlled, double-blind, parallel group, non-inferiority design trial of SRBC vs. CRBC tx for support of acute anemia in cardiac surgery patients (pts) was conducted at 5 study sites. RBCs were txed during and for up to 6 d post surgery; pts were followed to d 13 for adverse events (AEs), and to d 27 for serious AEs (SAEs). The primary endpoint was selected to measure adverse sequelae associated with inadequate tissue oxygenation by RBCs: a composite endpoint of myocardial infarction (MI), acute renal failure (ARF), and death. The trial had 80% power with 200 pts to show non-inferiority with an absolute difference of 15% in the primary endpoint compared to CRBC. Secondary endpoints were: RBC and other blood product use, change in hemoglobin (Hb), and AEs.Results : While this trial was enrolling, 2 asymptomatic pts in the chronic trial developed antibodies to SRBC, leading to early termination of both trials. At time of termination, 148 pts in the acute anemia trial had been txed. Despite the reduced sample size, the trial still has >70% power to show non-inferiority at the 0.05 significance level, assuming a common primary endpoint incidence of 20% for both groups. The 2 groups were balanced for demographics (mean age 68 yrs; 62% male; 95% Caucasian), type of surgery (68% intermediate risk group: repeat surgery or multiple procedures) and baseline characteristics. The primary endpoint was achieved: SRBC were not inferior to CRBC, with 1-sided 95% CI for treatment difference (SRBC-CRBC) of 12%. Results were similar by surgery and study site. Study RBCs only were received by 91% of pts; 41% of RBCs were txed during surgery. Other blood product use (see table) and AEs were similar in both groups. Tx reactions were uncommon. No antibodies to SRBC were detected in the acute trial.Endpoint SRBC CRBC p-Value* (n=74) (n=74) *2-sided p-value, testing for treatment difference. Composite endpoint (%) 22 21 1.00 MI (%) 0 2.7 0.25 ARF (%) 22 19 0.84 Death (%) 0 1.4 0.50 Mean change in Hb (g/dL) Pre vs. post-tx 1.4 1.5 0.74 Pre-surgery up to d 6 −2.6 −2.2 0.17 Mean no. RBC tx/units 2.1/4.4 1.9/3.8 0.49/0.20 Other blood product tx (% pts/mean no. units) FFP 47/2.1 45/2.5 0.87/0.55 Platelets 45/1.7 40/1.4 0.62/0.59 Cryo 6.8/0.5 11/0.5 0.40/0.94Conclusions : Although enrollment was not completed, efficacy endpoints for S-303-treated RBCs were comparable to conventional RBCs in this trial for support of acute anemia in cardiac surgery; no antibodies to S-303 RBC were detected; and the safety profile for S-303 RBCs was comparable to conventional RBCs. Processing improvements are being evaluated to reduce the immunogenicity potential associated with chronic exposure to S-303-treated RBCs.

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