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Biomedical subjects

Paul D Mintz

Publications and source records attributed to Paul D Mintz.

10 recordsLinked to original sources

Photochemically treated fresh frozen plasma for transfusion of patients with acquired coagulopathy of liver disease.

An ex vivo photochemical treatment (PCT) process was developed to inactivate pathogens in fresh frozen plasma (PCT-FFP). A prospective, controlled, double-blinded, randomized study was conducted to evaluate the efficacy and safety of PCT-FFP compared with conventional FFP (C-FFP). Patients (n = 121) with acquired coagulopathy, largely due to liver disease, including hepatic transplantation, were transfused with either PCT-FFP or C-FFP for up to 7 days. Primary end points were changes in the prothrombin time (PT) and the partial thromboplastin time (PTT) in response to the first FFP transfusion. Secondary analyses compared changes in the PT and the PTT, factor VII levels, clinical hemostasis, blood component usage, and safety following FFP transfusions for up to 7 days. Following the first transfusion, correction in the PT and PTT adjusted for FFP dose and patient weight was not different. Changes in the PT were equivalent between treatment groups (P = .002 by noninferiority). Equivalence was not demonstrated for changes in the PTT. Following multiple transfusions, correction of the PT and the PTT was similar between groups. No differences were observed in use of blood components, clinical hemostasis, or safety. These results suggest PCT-FFP supported hemostasis in the treatment of acquired coagulopathy similarly to conventional FFP.

Aged↗

A randomized, controlled Phase III trial of therapeutic plasma exchange with fresh-frozen plasma (FFP) prepared with amotosalen and ultraviolet A light compared to untreated FFP in thrombotic thrombocytopenic purpura.

BACKGROUND: Photochemical treatment of fresh-frozen plasma (FFP) with amotosalen and ultraviolet (UV) A light (PCT FFP) results in inactivation of a broad spectrum of pathogens while retaining coagulation factor activity, antithrombotic proteins, and von Willebrand factor-cleaving protease (VWF-CP) activity. STUDY DESIGN AND METHODS: A randomized, controlled, double-blind Phase III trial was conducted with PCT FFP or control FFP for therapeutic plasma exchange (TPE) in patients with thrombotic thrombocytopenic purpura (TTP). Owing to the rarity of this diagnosis, the trial was not powered to demonstrate small differences between treatment groups. Patients were treated with study FFP for a maximum of 35 days until remission was achieved (for a maximum of 30 daily study TPEs with no remission) plus an additional 5 days after remission. RESULTS: Among the 35 patients treated, the primary endpoint, remission within 30 days, was achieved by 14 of 17 (82%) PCT patients and 16 of 18 (89%) control patients (p = 0.658) The 90 percent confidence interval for treatment difference in remission rate for test - control was (-0.291 to 0.163). Time to remission, relapse rates, time to relapse, total volume and number of FFP units exchanged, and number of study TPEs were not significantly different between groups. Improvement in VWF-CP and inhibitors was similar for both groups. The overall safety profile of PCT FFP was similar to control FFP. No antibodies to amotosalen neoantigens were detected. CONCLUSION: The comparable results between treatment groups observed from this small trial suggest that TPE with PCT FFP was safe and effective for treatment of TTP.

Adolescent↗

Imported platelets demonstrate decreased pH and glucose by reagent strip testing when compared to locally derived platelets.

The most common infectious risk from blood transfusion in the United States is bacterial contamination of platelet components. Although detection of bacterially contaminated platelet components is best achieved with a culture system, AABB standards permit alternatives including the use of staining methods or reagent strips. In this study, 13,216 consecutive platelet components were screened using reagent strips for evidence of the presence of bacteria. Testing was performed immediately prior to release of the platelet components for transfusion; 10,836 were collected locally and 2,380 were imported from other blood banks. A mix of whole-blood-derived and apheresis products was included. If either the glucose concentration was <250 mg/ml or the pH was <7.0, the platelet component was quarantined and a specimen was obtained for Gram's stain and culture. Every transfused platelet component that was associated with a reported transfusion reaction was also tested by Gram's stain and culture. Overall, 1.47% of imported platelet components were reactive while only 0.12% of locally collected platelets were reactive. Of 48 reactive platelet components, 44 were tested by Gram's stain and culture. None was found to be bacterially contaminated. In summary, imported platelet components were significantly more likely to be falsely reactive by reagent strip screening as compared to locally prepared platelet components.

Bacteria↗

Assessment of the correlation of platelet morphology with in vivo recovery and survival.

BACKGROUND: There is continuing interest in the development of in vitro tests evaluating the in vivo function, recovery, and survival of platelets stored for transfusion. A recent forum concluded that no completely reliable test exists, although discoid morphology indicates a platelet's good health. We evaluated a novel device, the NAPSAC (Noninvasive Assessment of Platelet Shape and Concentration), designed to determine noninvasively the proportion of discoid platelets in a stored concentrate, as well as platelet concentration. STUDY DESIGN AND METHODS: Twenty-eight plateletapheresis concentrates stored 24 hours in PL-146 were evaluated. Percent discoid platelet results were correlated with radiolabeled autologous recovery and survival performed using 111Indium oxyquinoline and calculated using linear (L) and multiple-hit (M) models. pH of 8 concentrates was raised at the end of storage with 6N NaOH. Platelet concentration measured by NAPSAC and Coulter Thrombocounter C was compared in 256 plateletapheresis products. RESULTS: Percent discoid platelets at 24 hours did not correlate significantly with platelet recovery or survival (recovery L = 0.29, M = 0.28; survival L = 0.16, M = 0.03). Raising the pH (mean 6.38 to 6.94) resulted in a significant increase in percent discoid platelets (21% to 41%). Platelet concentration values for both methods studied were linearly correlated with a slope of 1.01 +/- 0.03, r = 0.81. CONCLUSION: Percent discoid platelets was not predictive of posttransfusion platelet recovery or survival. The results suggest that non-discoid platelets may survive posttransfusion and even revert to discoid shape, since raising the pH approximately doubled the percent of discoid platelets. The NAPSAC was shown to be a reliable instrument for noninvasively determining platelet concentration in PL-146 concentrates.

Blood Platelets↗

Therapeutic efficacy and safety of red blood cells treated with a chemical process (S-303) for pathogen inactivation: a Phase III clinical trial in cardiac surgery patients.

BACKGROUND: A randomized, double-blind trial is reported of the clinical efficacy of red blood cells (RBCs) treated for pathogen inactivation with S-303, a synthetic labile alkylating agent. STUDY DESIGN AND METHODS: Patients undergoing complex cardiac surgeries were randomly assigned to receive either S-303-treated (test) or conventional (control) RBC transfusion during surgery and for 6 days thereafter. Efficacy was evaluated by comparing the occurrence of a composite primary endpoint of treatment-related morbidity (myocardial infarction and renal failure) and mortality. RESULTS: Two-hundred twenty-three patients were randomly assigned and 148 patients who received transfusions (74 with S-303-treated RBCs and 74 with control RBCs) were evaluable. The incidence of the primary endpoint was equivalent between the two groups (22 and 21% in the S-303-treated and control RBC groups, respectively). Secondary endpoints, including hemoglobin increment (mean, 1.4 vs. 1.5 g/dL), number of RBC transfusions (mean, 4.4 vs. 3.8 units), and other blood product support, were also comparable. The adverse event profile was similar between groups; however, patients who received S-303 RBCs were significantly more likely to develop constipation and less likely to suffer supraventricular extrasystoles. Four patients (2 test and 2 control) demonstrated positive indirect antiglobulin tests with reactivity for S-303 RBCs at one or more time points before or after transfusion, without evidence of hemolysis. CONCLUSION: S-303-treated and conventional RBCs were equivalent with respect to clinical efficacy and safety in supporting the transfusion needs of cardiac surgery patients. Investigations are under way to ascertain the significance of S-303 RBC antibodies and to prevent their occurrence.

Acridines↗

Report of two cases: Rattlesnake venom-induced thrombocytopenia.

We report 2 patients who presented with vasomotor symptoms and severe thrombocytopenia following rattlesnake bites. These symptoms persisted in spite of treatment with antivenin and transfusion of multiple doses of platelets. Thrombocytopenia is a common occurrence in moderate to severe crotaline envenomation. Algorithms suggested for the treatment of rattlesnake envenomation with crotaline-specific antivenin may not reverse the associated thrombocytopenia. The precise mechanism of venom-induced thrombocytopenia (VIT), even in the absence of significant coagulopathy, is unknown. Our experience suggests that, unless spontaneous bleeding occurs, repeated transfusion of fresh frozen plasma and/or platelets may not be indicated.

Adult↗

Blood use in cerebrovascular neurosurgery.

BACKGROUND AND PURPOSE: This study reviews the perioperative use of red blood cell transfusion in cerebrovascular neurosurgery. The current algorithm for preoperative ordering of red cells is historical and dated. More blood is ordered than is actually transfused, and considerable variability exists between different institutions. We determine the use of blood transfusion in cerebrovascular surgery to develop a rational blood ordering practice. METHODS: Records of 301 patients undergoing cerebrovascular neurosurgery at the University of Virginia were reviewed to quantitatively evaluate red blood cell transfusion practices. The amount and reason for transfusion were noted in each case. RESULTS: In 126 patients undergoing carotid endarterectomy, there were no preoperative or intraoperative transfusions and 5 postoperative transfusions (4.0%). In 71 ruptured aneurysm patients, there were 2 preoperative blood transfusions (2.8%), 4 intraoperative transfusions (5.6%), and 15 postoperative transfusions (21.1%). Forty-seven patients underwent surgery for unruptured aneurysms, with no preoperative transfusions, 2 intraoperative transfusions (4.3%), and 8 postoperative blood transfusions (17.0%). Of the 54 patients undergoing surgery for arteriovenous malformations, 5 patients (9.3%) were transfused preoperatively, 4 were transfused intraoperatively (7.4%), and 22 were transfused postoperatively (40.7%). None of the 3 patients undergoing surgery for concomitant arteriovenous malformations and aneurysms received intraoperative blood transfusions, but 1 received blood both preoperatively and postoperatively, and another received a transfusion postoperatively only. The overall ratio of perioperative cross-match to transfusion in this series is 41.4. CONCLUSIONS: In vascular neurosurgery at our institution, blood has routinely been ordered excessively. We recommend an ABO-Rh type and antibody screen for aneurysm and arteriovenous malformation surgery and no screen for carotid endarterectomy to efficiently utilize transfusion therapy in cerebrovascular surgery.

Blood Grouping and Crossmatching↗