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Local Versus Systemic Tranexamic Acid in Total Hip Arthroplasty in Young Adults
Kushwaha NS, Singh S, Kumar S, Singh A, Abbas MB, Deshwal S, Agarwal R
Cureus. 2023;15(3):e36230
Abstract
Background Total hip arthroplasty (THA) is the most successful orthopedic elective surgical procedure for end-stage hip arthritis. THA is linked with significant blood loss, ranging from 1,188 to 1,651 mL, and a transfusion rate of 16-37%, which frequently results in postoperative blood transfusions. Postoperative blood transfusions can be avoided by using autologous blood transfusion, intraoperative blood saving, local anesthetic, hypotensive anesthesia, and antifibrinolytic medications such as tranexamic acid (TXA) administration. Methodology A double-blinded, placebo-controlled, randomized, controlled study was conducted with three prospective groups to investigate the efficacy of topical and systemic routes of a single intraoperative dose (1.5 g) of TXA. Patients were recruited from our center between October 2021 to March 2022 who were undergoing primary total hip replacement. Estimated blood loss was calculated and compared in groups, and a p-value of <0.05 was taken as significant. Results A total of 60 patients were recruited in our study. Estimated blood loss was similar in both treatment groups, 816.8 ± 219.9 mL in the systemic TXA group and 775.5 ± 107.2 mL in the topical TXA group. The placebo group had 1,066.3 ± 150.4 mL estimated blood loss, which was significantly higher compared to the treatment groups. Conclusions Administration of TXA (1.5 g) significantly lowers blood loss without increasing problems, which can eliminate concerns about intravenous TXA use. TXA reduces blood loss by 270 mL on average.
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Comparing Tubeless and Tubed Approaches in Percutaneous Nephrolithotomy for Moderate Renal Calculi: Outcomes on Safety, Efficacy, Pain Management, Recovery Time, and Cost-Effectiveness
Kr S, Singh A, Sharma P, Pai V, Choudhary A, Patil S
Cureus. 2023;15(5):e39211
Abstract
Introduction This study focuses on investigating the effect of routine nephrostomy tube placement in patients with moderate renal calculi of size 2.5 cm or less who undergo uncomplicated percutaneous nephrolithotomy (PCNL) procedures. Previous studies have not specified whether only uncomplicated cases were included in the analysis, which may affect the results. This study aims to provide a clearer understanding of the effect of routine nephrostomy tube placement on blood loss in a more homogeneous patient population. Materials and methods A prospective randomized controlled trial (RCT) was conducted at our department over 18 months, dividing 60 patients with a single renal or upper ureteric calculus of size ≤2.5 cm into two groups: 30 patients in each group (group 1: tubed PCNL, group 2: tubeless PCNL). The primary outcome was the drop in perioperative hemoglobin level and the number of packed cell transfusions necessary. The secondary outcome included the mean pain score, analgesic requirement, length of hospital stay, time to return to normal activities, and the total cost of the procedure. Results The two groups were comparable in age, gender, comorbidities, and stone size. The postoperative hemoglobin level was significantly lower in the tubeless PCNL group (9.56 ± 2.13 gm/dL) compared to the tube PCNL group (11.32 ± 2.35 gm/dL) (p = 0.0037), and two patients in the tubeless group required blood transfusion. The duration of surgery, pain scores, and analgesic requirement were comparable between the two groups. The total procedure cost was significantly lower in the tubeless group (p = 0.0019), and the duration of hospital stay and time to return to daily activities were significantly shorter in the tubeless group (p < 0.0001). Conclusions Tubeless PCNL is a safe and effective alternative to conventional tube PCNL, with the advantages of shorter hospital stay, faster recovery, and lower procedure costs. Tube PCNL is associated with less blood loss and the need for transfusions. Patient preferences and bleeding risk should be considered when choosing between the two procedures.
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Therapeutic Strategies in Traumatic Intracranial Hemorrhage and Outcomes
Singh A, Trivedi R, Ahmed N
Journal of neurological surgery. Part A, Central European neurosurgery. 2022
Abstract
BACKGROUND Traumatic intracranial hemorrhage (TICH) and its progression have historically resulted in poor prognosis and functional disability. Such outcomes can impact the daily lives and financial condition of patients' families as well as add burden to the health care system. This review examines the diverse therapeutic intervention that were observed in randomized clinical trials (RCT) on various outcomes. Many demographic and clinical risk factors have been identified for poor prognosis after a TICH. Among the many therapeutic strategies studied, few found to have some beneficial effect in minimizing the progression of hemorrhage and reducing the overall mortality. METHODS A literature review was conducted of all relevant sources using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines to include articles that were RCTs for patients aged 18 years and above to include a total of 19 articles. RESULTS Across studies, many therapies have been assessed; however, only few findings including infusion of tranexamic acid (TXA), use of β-blocker, and early operative evacuation of TICH yielded favorable results. Use of steroid and blood transfusion to target higher hemoglobin levels showed evidence of adversely impacting the outcome. CONCLUSION Of the many therapeutic strategies available for TICH, very few therapies have proven to be beneficial.
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A Randomised Controlled Trial to Compare Injection Ferric Carboxymaltose and Oral Iron in Treating Iron Deficiency Anemia During Pregnancy
Chawla S, Singh A, Jhamb D, Anupama CH
Journal of obstetrics and gynaecology of India. 2022;72(6):492-496
Abstract
INTRODUCTION Iron deficiency anemia (IDA) in pregnancy has a prevalence as high as 40-60% in different countries of the world. Oral iron is used to treat his commonest medical disorder in pregnancy. Ferrous sulphate is associated with considerable side effects. Ferric carboxymaltose (FCM) is a newer iron preparation which allows for single and higher dose (up to 1000 mg) of IV iron infusion. This study was conducted to compare the efficacy of FCM and FS in treating IDA during pregnancy. METHODS A randomised control trial was done at a tertiary care centres involving 362 women (181 women each in FS and FCM group). The pregnant anemic women with IDA were enrolled between 18 and 34 weeks of pregnancy. They were given 1000 mg of FCM iv as single dose or were given FS tablets twice daily (120 mg iron daily). The data were collected for rise in the Hb and serum ferritin over a period of 6 weeks. RESULTS Nine and 18 patients were lost to follow-up in the FCM and FS group, respectively. The data were analysed as per protocol analysis. FCM group women showed 2.6 gm% rise in Hb compared to 1.7 gm% of FS group. One hundred and sixty-six out of 172 women in FS group achieved anemia correction at 6 weeks. No difference was observed in the neonatal outcome. No major side effects were observed in the either group. CONCLUSION In our study, FCM was more effective than oral FS in increasing Hb in women with IDA during pregnancy. This clinical benefit with FCM was achieved without the concerns for safety and tolerability of the drug.
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Prospective Comparison of Functional and Radiological Outcomes of Arthroscopic Anterior Cruciate Ligament Reconstruction by Hamstring Graft Alone and Platelet-Rich Plasma Added to the Hamstring Graft
Kumar A, Kushwaha NS, Kumar D, Singh A, Gupta V, Kumar S
Cureus. 2022;14(3):e23017
Abstract
AIMS AND OBJECTIVES To measure the additional effect of platelet-rich plasma (PRP) on functional outcome of anterior cruciate ligament tear managed by augmenting anterior cruciate ligament (ACL) reconstruction with PRP. METHODS The present study was conducted on patients with ACL tear admitted in the department of orthopaedics, King George's Medical University, Lucknow wherein a total of 70 subjects were assigned into two groups of 35 patients each randomly, viz Group 1 in which the patients were treated by quadruple hamstring graft alone and Group 2 in which the patients were treated with augmented hamstring graft with PRP. The standardized anterior drawer test, Lachman's test, Lysholm knee score were quantified both preoperatively and postoperatively at different follow-ups and also tibial tunnel widening was measured postoperatively at different follow-ups. RESULT The present study had 70 patients with ACL tears. The mean age of patients in non-PRP groups was 29.71 ±2.99 years while that in the PRP group was 28.34±4.32 years. On comparing the improvement in grades at pre-op, immediate postop, 6 weeks, and 3 months follow-ups, there was no statistically significant difference between the two groups. The tibial tunnel widening also showed no significant difference between the two groups. CONCLUSION In our study, it was found that both the groups showed improvements in grades of anterior drawer test and Lachman's test postoperatively but the difference between both the groups was not significant. Similarly, while comparing the improvements in Lysholm knee score and tibial tunnel widening among both the groups, the difference was not significant. Follow up of 3 months was a limiting factor in our study. This technique needs further clinical evaluation to assess the long-term results.
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Evaluation of Direct Oral Anticoagulant Reversal Agents in Intracranial Hemorrhage: A Systematic Review and Meta-analysis
Chaudhary R, Singh A, Chaudhary R, Bashline M, Houghton DE, Rabinstein A, Adamski J, Arndt R, Ou NN, Rudis MI, et al
JAMA network open. 2022;5(11):e2240145
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Editor's Choice
Abstract
IMPORTANCE Direct oral anticoagulant (DOAC)-associated intracranial hemorrhage (ICH) has high morbidity and mortality. The safety and outcome data of DOAC reversal agents in ICH are limited. OBJECTIVE To evaluate the safety and outcomes of DOAC reversal agents among patients with ICH. DATA SOURCES PubMed, MEDLINE, The Cochrane Library, Embase, EBSCO, Web of Science, and CINAHL databases were searched from inception through April 29, 2022. STUDY SELECTION The eligibility criteria were (1) adult patients (age ≥18 years) with ICH receiving treatment with a DOAC, (2) reversal of DOAC, and (3) reported safety and anticoagulation reversal outcomes. All nonhuman studies and case reports, studies evaluating patients with ischemic stroke requiring anticoagulation reversal or different dosing regimens of DOAC reversal agents, and mixed study groups with DOAC and warfarin were excluded. DATA EXTRACTION AND SYNTHESIS Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines were used for abstracting data and assessing data quality and validity. Two reviewers independently selected the studies and abstracted data. Data were pooled using the random-effects model. MAIN OUTCOMES AND MEASURES The primary outcome was proportion with anticoagulation reversed. The primary safety end points were all-cause mortality and thromboembolic events after the reversal agent. RESULTS A total of 36 studies met criteria for inclusion, with a total of 1832 patients (967 receiving 4-factor prothrombin complex concentrate [4F-PCC]; 525, andexanet alfa [AA]; 340, idarucizumab). The mean age was 76 (range, 68-83) years, and 57% were men. For 4F-PCC, anticoagulation reversal was 77% (95% CI, 72%-82%; I2 = 55%); all-cause mortality, 26% (95% CI, 20%-32%; I2 = 68%), and thromboembolic events, 8% (95% CI, 5%-12%; I2 = 41%). For AA, anticoagulation reversal was 75% (95% CI, 67%-81%; I2 = 48%); all-cause mortality, 24% (95% CI, 16%-34%; I2 = 73%), and thromboembolic events, 14% (95% CI, 10%-19%; I2 = 16%). Idarucizumab for reversal of dabigatran had an anticoagulation reversal rate of 82% (95% CI, 55%-95%; I2 = 41%), all-cause mortality, 11% (95% CI, 8%-15%, I2 = 0%), and thromboembolic events, 5% (95% CI, 3%-8%; I2 = 0%). A direct retrospective comparison of 4F-PCC and AA showed no differences in anticoagulation reversal, proportional mortality, or thromboembolic events. CONCLUSIONS AND RELEVANCE In the absence of randomized clinical comparison trials, the overall anticoagulation reversal, mortality, and thromboembolic event rates in this systematic review and meta-analysis appeared similar among available DOAC reversal agents for managing ICH. Cost, institutional formulary status, and availability may restrict reversal agent choice, particularly in small community hospitals.
PICO Summary
Population
Adult patients with intracranial hemorrhage receiving treatment with a direct oral anticoagulant (36 studies, n= 1,832).
Intervention
4-factor prothrombin complex concentrate (4F-PCC), (n= 967).
Comparison
Andexanet alfa (AA), (n= 525). Idarucizumab(n= 340).
Outcome
For 4F-PCC, anticoagulation reversal was 77% (95% CI 72% to 82%; I2 = 55%); all-cause mortality, 26% (95% CI 20% to 32%; I2 = 68%), and thromboembolic events, 8% (95% CI 5% to 12%; I2 = 41%). For AA, anticoagulation reversal was 75% (95% CI 67% to 81%; I2 = 48%); all-cause mortality, 24% (95% CI 16% to 34%; I2 = 73%), and thromboembolic events, 14% (95% CI 10% to 19%; I2 = 16%). Idarucizumab for reversal of dabigatran had an anticoagulation reversal rate of 82% (95% CI 55% to 95%; I2 = 41%), all-cause mortality, 11% (95% CI 8% to 15%, I2 = 0%), and thromboembolic events, 5% (95% CI 3% to 8%; I2 = 0%). A direct retrospective comparison of 4F-PCC and AA showed no differences in anticoagulation reversal, proportional mortality, or thromboembolic events.
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Early Outpatient Treatment for Covid-19 with Convalescent Plasma
Sullivan DJ, Gebo KA, Shoham S, Bloch EM, Lau B, Shenoy AG, Mosnaim GS, Gniadek TJ, Fukuta Y, Patel B, et al
The New England journal of medicine. 2022
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Editor's Choice
Abstract
BACKGROUND Polyclonal convalescent plasma may be obtained from donors who have recovered from coronavirus disease 2019 (Covid-19). The efficacy of this plasma in preventing serious complications in outpatients with recent-onset Covid-19 is uncertain. METHODS In this multicenter, double-blind, randomized, controlled trial, we evaluated the efficacy and safety of Covid-19 convalescent plasma, as compared with control plasma, in symptomatic adults (≥18 years of age) who had tested positive for severe acute respiratory syndrome coronavirus 2, regardless of their risk factors for disease progression or vaccination status. Participants were enrolled within 8 days after symptom onset and received a transfusion within 1 day after randomization. The primary outcome was Covid-19-related hospitalization within 28 days after transfusion. RESULTS Participants were enrolled from June 3, 2020, through October 1, 2021. A total of 1225 participants underwent randomization, and 1181 received a transfusion. In the prespecified modified intention-to-treat analysis that included only participants who received a transfusion, the primary outcome occurred in 17 of 592 participants (2.9%) who received convalescent plasma and 37 of 589 participants (6.3%) who received control plasma (absolute risk reduction, 3.4 percentage points; 95% confidence interval, 1.0 to 5.8; P = 0.005), which corresponded to a relative risk reduction of 54%. Evidence of efficacy in vaccinated participants cannot be inferred from these data because 53 of the 54 participants with Covid-19 who were hospitalized were unvaccinated and 1 participant was partially vaccinated. A total of 16 grade 3 or 4 adverse events (7 in the convalescent-plasma group and 9 in the control-plasma group) occurred in participants who were not hospitalized. CONCLUSIONS In participants with Covid-19, most of whom were unvaccinated, the administration of convalescent plasma within 9 days after the onset of symptoms reduced the risk of disease progression leading to hospitalization. (Funded by the Department of Defense and others; CSSC-004 ClinicalTrials.gov number, NCT04373460.).
PICO Summary
Population
Symptomatic adults who tested positive for severe acute respiratory syndrome coronavirus 2, at 23 trial sites in the United States (n= 1,225).
Intervention
Convalescent plasma transfusion (n= 610).
Comparison
Control plasma transfusion (n= 615).
Outcome
Covid-19-related hospitalization within 28 days after transfusion occurred in 17 of 592 patients (2.9%) who received convalescent plasma and 37 of 589 patients (6.3%) who received control plasma, which corresponded to a relative risk reduction of 54%. Evidence of efficacy in vaccinated patients could not be inferred. A total of 16 grade 3 or 4 adverse events (7 in the convalescent-plasma group and 9 in the control-plasma group) occurred in patients who were not hospitalized.
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Propranolol vs. band ligation for primary prophylaxis of variceal hemorrhage in cirrhotic patients with ascites: a randomized controlled trial
Singh V, Kumar P, Verma N, Vijayvergiya R, Singh A, Bhalla A
Hepatology international. 2022
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Abstract
BACKGROUND AND AIMS Recent studies have debated the utility of beta-blockers to prevent variceal hemorrhage (V.H.) in cirrhosis patients with ascites. We aimed to evaluate the safety and efficacy of propranolol (PPL) compared to endoscopic variceal ligation (EVL) for V.H. primary prevention in patients with ascites. METHODS Cirrhosis patients with ≥ grade 2 ascites and varices needing primary prophylaxis were randomly assigned to receive either PPL (n = 80) or EVL (n = 80). Patients were followed monthly until 12 months or transplant or death. The primary endpoint was 12-month transplant-free-survival (TFS). Secondary endpoints were the incidence of V.H., acute kidney injury (AKI), and control of ascites. RESULTS Baseline characteristics were similar between the groups. PPL-group had a lower 12-month TFS (76.0% vs. 89.7%; p = 0.02) as compared with EVL-group. Mean arterial pressure ≤ 82 mmHg and MELD-sodium were the independent predictors of mortality. Incidence of VH was comparable between PPL and EVL-groups [6 (7.5%) vs. 2 (2.5%), p = 0.13]. In PPL vs. EVL-group, more patients had worsening of ascites (15% vs. 5%; p = 0.03), developed refractory ascites (13.7% vs.3.7%; p = 0.02), relapse of ascites (37.1% vs. 16.4%, p < 0.01), and AKI (26.2% vs. 12.5%; p = 0.02). Side effects were comparable between the two groups. CONCLUSIONS Primary VH-prophylaxis with PPL is associated with lower survival, poor control of ascites, and increased risk of AKI in cirrhosis patients with ≥ grade 2 ascites. PPL and EVL are equally effective in preventing V.H. Serial monitoring of blood pressures and renal functions is needed in cirrhosis patients with ascites on PPL (NCT02649335).
PICO Summary
Population
Cirrhosis patients with ascites and esophageal varices (n= 160).
Intervention
Propranolol (PPL), (PPL group, n= 80).
Comparison
Endoscopic variceal ligation (EVL), (EVL group, n= 80).
Outcome
Patients receiving PPL had a lower 12-month transplant-free-survival (76.0% vs. 89.7%) compared with patients who had EVL. Mean arterial pressure ≤ 82 mmHg and MELD-sodium were the independent predictors of mortality. Incidence of variceal haemorrhage was comparable between the PPL and EVL groups [6 (7.5%) vs. 2 (2.5%)]. In the PPL vs. EVL group, more patients had worsening of ascites (15% vs. 5%), developed refractory ascites (13.7% vs. 3.7%), relapse of ascites (37.1% vs. 16.4%), and acute kidney injury (26.2% vs. 12.5%). Side effects were comparable between both groups.
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Standard-Volume Plasma Exchange Improves Outcomes in Patients With Acute Liver Failure: A Randomized Controlled Trial
Maiwall R, Bajpai M, Singh A, Agarwal T, Kumar G, Bharadwaj A, Nautiyal N, Tevethia H, Jagdish RK, Vijayaraghavan R, et al
Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association. 2022;20(4):e831-e854
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Editor's Choice
Abstract
BACKGROUND High volume plasma-exchange (HVPE) improves survival in patients with acute liver failure (ALF), but apprehension regarding volume overload and worsening of cerebral edema remain. METHODS In an open-label randomized controlled trial, 40 consecutive patients of ALF were randomized 1:1 to either standard medical treatment (SMT) or SMT with standard-volume plasma-exchange (SVPE). SVPE was performed using centrifugal apheresis [target volume of 1.5 to 2.0 plasma volumes per session] until desired response was achieved. Cerebral edema was assessed by brain imaging. Results were analyzed in an intention-to-treat analysis. Primary outcome was 21-day transplant-free survival. The levels of cytokines, damage-associated molecular patterns (DAMPs) and endotoxins were analyzed at baseline and day 5. RESULTS ALF patients [aged 31.5 ± 12.2 years, 60% male, 78% viral, 83% hyperacute, 70% with SIRS were included. At day 5, SVPE [mean sessions 2.15 ± 1.42, median plasma volume replaced 5.049 L] compared to SMT alone, resulted in higher lactate clearance (p = .02), amelioration of SIRS (84% vs. 26%; P = .02), reduction in ammonia levels [(221.5 ± 96.9) vs.(439 ± 385.6) μg/dl, P = .02) and SOFA scores [9.9(±3.3) vs. 14.6(±4.8); P = .001]. There were no treatment related deaths. SVPE was associated with a higher 21-day transplant free-survival [75% vs. 45%; P = .04, HR 0.30, 95%CI 0.01-0.88]. A significant decrease in levels of pro-inflammatory cytokines and an increase in anti-inflammatory cytokines along with a decrease in endotoxin and DAMPs was seen with SVPE. CONCLUSION In ALF patients with cerebral edema, SVPE is safe and effective and improves survival possibly by a reduction in cytokine storm and ammonia. CLINICALTRIAL gov (identifier: NCT02718079).
PICO Summary
Population
Patients with acute liver failure (n= 40).
Intervention
Standard medical treatment with standard volume plasma exchange (SVPE), (n= 20).
Comparison
Standard medical treatment (n= 20).
Outcome
Compared to standard medical treatment alone, at day five SVPE resulted in higher lactate clearance, amelioration of systemic inflammatory response syndrome (84% vs. 26%), reduction in ammonia levels [(221.5 ± 96.9) vs. (439 ± 385.6) μg/dl] and sequential organ failure assessment scores [9.9(±3.3) vs. 14.6(±4.8)]. There were no treatment related deaths. SVPE was associated with a higher 21-day transplant free-survival (75% vs. 45%). A significant decrease in levels of pro-inflammatory cytokines and an increase in anti-inflammatory cytokines along with a decrease in endotoxin and damage-associated molecular patterns was seen with SVPE.
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Randomized Controlled Trial of Early Outpatient COVID-19 Treatment with High-Titer Convalescent Plasma
Sullivan DJ, Gebo KA, Shoham S, Bloch EM, Lau B, Shenoy AG, Mosnaim GS, Gniadek TJ, Fukuta Y, Patel B, et al
medRxiv : the preprint server for health sciences. 2021
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Editor's Choice
Abstract
BACKGROUND The efficacy of polyclonal high titer convalescent plasma to prevent serious complications of COVID-19 in outpatients with recent onset of illness is uncertain. METHODS This multicenter, double-blind randomized controlled trial compared the efficacy and safety of SARS-CoV-2 high titer convalescent plasma to placebo control plasma in symptomatic adults ≥18 years positive for SARS-CoV-2 regardless of risk factors for disease progression or vaccine status. Participants with symptom onset within 8 days were enrolled, then transfused within the subsequent day. The measured primary outcome was COVID-19-related hospitalization within 28 days of plasma transfusion. The enrollment period was June 3, 2020 to October 1, 2021. RESULTS A total of 1225 participants were randomized and 1181 transfused. In the pre-specified modified intention-to-treat analysis that excluded those not transfused, the primary endpoint occurred in 37 of 589 (6.3%) who received placebo control plasma and in 17 of 592 (2.9%) participants who received convalescent plasma (relative risk, 0.46; one-sided 95% upper bound confidence interval 0.733; P=0.004) corresponding to a 54% risk reduction. Examination with a model adjusting for covariates related to the outcome did not change the conclusions. CONCLUSION Early administration of high titer SARS-CoV-2 convalescent plasma reduced outpatient hospitalizations by more than 50%. High titer convalescent plasma is an effective early outpatient COVID-19 treatment with the advantages of low cost, wide availability, and rapid resilience to variant emergence from viral genetic drift in the face of a changing pandemic. TRIAL REGISTRATION ClinicalTrials.gov number, NCT04373460 .
PICO Summary
Population
SARS-CoV-2 positive adults within 8 days of symptom onset (n= 1,225).
Intervention
High titre convalescent plasma (n= 592).
Comparison
ABO compatible control plasma (n= 589).
Outcome
A total of 1,181 patients were transfused. In the pre-specified modified intention-to-treat analysis that excluded those not transfused, the primary endpoint occurred in 37 of 589 (6.3%) patients who received ABO compatible control plasma and in 17 of 592 (2.9%) patients who received convalescent plasma corresponding to a 54% risk reduction.