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A Randomized Controlled Study Assessing Convalescent Immunoglobulins versus Convalescent Plasma for Hospitalized COVID-19 Patients
Maor Y, Shinar E, Izak M, Rahav G, Brosh-Nissimov T, Kessler A, Rahimi-Levene N, Benin-Goren O, Cohen D, Zohar I, et al
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America. 2023
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Abstract
BACKGROUND It is unknown whether convalescent immunoglobulins (cIgG) are better than convalescent plasma (CP) for COVID-19 patients. METHODS In this randomized trial we assigned high risk COVID-19 with ≤10 days of symptoms, to receive cIgG or CP. The primary endpoint was improvement on day 14 according to the WHO scale. Secondary endpoints were survival on day 14, and improvement, survival, and percent of ventilated patients on day 28 and treatment response in unvaccinated and vaccinated patients. RESULTS 319 patients were included; 166 received cIgG, and 153 CP. Median age was 64-66 years. 112 patients (67.5%) in the cIgG and 103 patients (67.3%) in the CP group reached the primary endpoint. Difference between groups was 0.1 (95%CI -10.1-10.4, p=0.026), failing to reach non-inferiority. More patients receiving cIgG improved by day 28 [136 patients (81.9%) and 108 patients (70.6%), respectively, 95% CI 1.9-20.7, p<0.001, for superiority p=0.018)]. 17 patients in the cIgG group (10.2%) and 25 patients (16.3%) in the CP group required mechanical ventilation (p=0.136). 16 (9.6%) and 23 (15%) patients respectively died (p=0.172). More unvaccinated patients improved by day 28 in the cIgG group (84.1% vs. 66.1%, p<0.024) and survival was better in the cIgG group (89.9% vs. 77.4% p=0.066). CONCLUSIONS cIgG failed to reach the primary non-inferiority endpoint on day 14 but was superior to CP on day 28. Survival and improvement by day 28 in unvaccinated patients treated with cIgG were better. In the face of new variants, cIgG is a viable option for treating COVID-19. TRIAL REGISTRATION NUMBER My Trials MOH_2021-01-14_009667.
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Impact of disasters on blood donation rates and blood safety: A systematic review and meta-analysis
Laermans J, O D, Van den Bosch E, De Buck E, Compernolle V, Shinar E, Vandekerckhove P
Vox sanguinis. 2022
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Abstract
BACKGROUND AND OBJECTIVES Timely and adequate access to safe blood forms an integral part of universal health coverage, but it may be compromised by natural or man-made disasters. This systematic review provides MATERIALS AND METHODS Five databases (The Cochrane Library, MEDLINE, Embase, Web of Science and CINAHL) were searched until 27 March 2020 for (un)controlled studies investigating the impact of disasters on blood donation rates and/or safety. Risk of bias and overall certainty of the evidence were assessed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. RESULTS Eighteen observational studies were identified, providing very low certainty of evidence (due to high risk of bias, inconsistency and/or imprecision) on the impact of natural (12 studies) and man-made/technological (6 studies) disasters. The available evidence did not enable us to form any generalizable conclusions on the impact on blood donation rates. Meta-analyses could not detect any statistically significant changes in transfusion-transmissible infection (TTI) rates [hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV)-1/2, human T-lymphotropic virus I and II (HTLV-I/II) and syphilis] in donated blood after a disaster, either in first-time or repeat donors, although the evidence is very uncertain. CONCLUSION The very low certainty of evidence synthetized in this systematic review indicates that it is very uncertain whether there is an association between disaster occurrence and changes in TTI rates in donated blood. The currently available evidence did not allow us to draw generalizable conclusions on the impact of disasters on blood donation rates.
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Cognitive and physical performance are well preserved following standard blood donation: A noninferiority, randomized clinical trial
Nadler R, Tsur AM, Lipsky AM, Lending G, Benov A, Ostffeld I, Shinar E, Yanovich R, Moser A, Levy D, et al
Transfusion. 2020
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Editor's Choice
Abstract
BACKGROUND A walking blood bank (WBB) refers to the use of fellow combatants for battlefield blood donation. This requires pretesting combatants for infectious diseases and blood type. A fundamental prerequisite for this technique is that the donating soldier will suffer minimal physiological and mental impact. The purpose of the current study is to assess the effect of blood shedding on battlefield performance. METHODS This is a double-blind randomized control trial. Forty Israel Defense Forces combatants volunteered for the study. Participants underwent baseline evaluation, including repeated measurement of vital signs, cognitive evaluation, physical evaluation, and a strenuous shooting test. Three weeks after the baseline evaluation, subjects were randomized to either blood donation or the control group. For blinding purposes, all subjects underwent venous catheterization for the duration of a blood donation. Repeated vital signs and function evaluation were then performed. RESULTS Thirty-six patients were available for randomization. Baseline measurements were similar for both groups. Mean strenuous shooting score was 80.5 +/- 9.5 for the control group and 82 +/- 6.6 for the test group (p = 0.58). No clinically or statistically significant differences were found in tests designed to evaluate cognitive performance or physical functions. Vital signs taken multiple times were also similar between the test and control groups. CONCLUSIONS Executive, cognitive, and physical functions were well preserved after blood donation. This study supports the hypothesis that a WBB does not decrease donor combat performance. The categorical prohibition of physical exercise following blood donation might need to be reconsidered in both military and civilian populations.
PICO Summary
Population
Infantry combatants (n= 36).
Intervention
Blood donation group: 450ml of blood collected after venous catheterisation (n= 18).
Comparison
Control group: venous catheterisation (n= 18).
Outcome
No clinically or statistically significant differences were found in tests designed to evaluate cognitive performance or physical functions. Vital signs taken multiple times were also similar between the test and control groups.
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Aprotinin improves hemostasis after cardiopulmonary bypass better than single-donor platelet concentrate
Shinfeld A, Zippel D, Lavee J, Lusky A, Shinar E, Savion N, Mohr R
Annals of Thoracic Surgery. 1995;59((4):):872-6.
Abstract
Platelet transfusion and aprotinin administration improve platelet function and clinical hemostasis after extracorporeal circulation. To compare two methods of improving postoperative hemostasis, we preoperatively randomized 40 patients undergoing various open heart procedures into two groups. Group A included 20 patients who, immediately after bypass, received single-donor plateletpheresis concentrates collected from ABO-compatible donors (Baxter Autopheresis-C System). They were compared with 20 patients who received high-dose aprotinin (6 x 10(6) KIU) before and during cardiopulmonary bypass (group B). Group A patients showed significantly higher platelet count after single-donor plateletpheresis concentrate transfusion (157 +/- 36 x 10(9)/L compared with 118 +/- 42 x 10(9)/L (p < 0.05). However, platelet aggregation on extracellular matrix was better in group B (3.4 +/- 0.7 versus 2.8 +/- 0.9; p < 0.05). Total 24-hour blood loss and exposure to homologous blood products were significantly less in group B (396 +/- 125 mL and 1.1 +/- 1.6 units compared with 617 +/- 233 mL and 5.4 +/- 3.4 units; p < 0.01). Despite higher platelet count in patients after single-donor plateletpheresis concentrates transfusion, hemostasis in patients receiving aprotinin is better due to improved platelet function.