scholarly journals A Pilot Randomized Controlled Trial of de novo Belatacept-Based Immunosuppression in Lung Transplantation

2021 ◽  
Author(s):  
Howard J Huang ◽  
Kenneth Schechtman ◽  
Medhat Askar ◽  
Cory Bernadt ◽  
Brigitte Mittler ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Mycophenolate Mofetil ◽  
Lung Transplantation ◽  
De Novo ◽  
Controlled Trial ◽  
Adverse Outcomes ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Donor Specific Antibodies ◽  
Pilot Randomized Controlled Trial

The development of donor-specific antibodies (DSA) after lung transplantation is common and results in adverse outcomes. In kidney transplantation, Belatacept has been associated with a lower incidence of DSA, but experience with Belatacept in lung transplantation is limited. We conducted a 2-center pilot randomized controlled trial of de novo immunosuppression with Belatacept after lung transplantation to assess the feasibility of conducting a pivotal trial. Twenty-seven participants were randomized to Control (Tacrolimus, Mycophenolate Mofetil, and prednisone, n = 14) or Belatacept-based immunosuppression (Tacrolimus, Belatacept, and prednisone until day 89 followed by Belatacept, Mycophenolate Mofetil, and prednisone, n = 13). All participants were treated with rabbit anti-thymocyte globulin for induction immunosuppression. We permanently stopped randomization and treatment with Belatacept after 3 participants in the Belatacept arm died compared to none in the Control arm. Subsequently, 2 additional participants in the Belatacept arm died for a total of 5 deaths compared to none in the Control arm (log rank p = 0.016). We did not detect a significant difference in DSA development, acute cellular rejection, or infection between the 2 groups. We conclude that this investigational regimen using Belatacept after lung transplantation is associated with significantly increased mortality.

scholarly journals Effect of Electroacupuncture versus Sham Electroacupuncture in Patients with Knee Osteoarthritis: A Pilot Randomized Controlled Trial

2020 ◽  
Vol 2020 ◽  
pp. 1-9
Author(s):  
Qi Wang ◽  
Hui Lv ◽  
Zhao-Tian Sun ◽  
Jian-Feng Tu ◽  
Yong-Wei Feng ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Muscle Strength ◽  
Knee Osteoarthritis ◽  
Range Of Motion ◽  
Controlled Trial ◽  
Dropout Rate ◽  
Flexor Muscle ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Pilot Randomized Controlled Trial

Objective. To explore the feasibility of evaluating the effectiveness and safety of electroacupuncture versus sham electroacupuncture for patients with knee osteoarthritis (KOA). Method. A pilot randomized controlled trial was conducted at a teaching hospital in Beijing. A total of 30 patients with KOA (Kellgren grade II or III) were randomly allocated to an eight-week treatment of either electroacupuncture or sham electroacupuncture. Patients and outcome assessors were blinded to group allocation. The primary outcome was the proportion of responders achieving at least 1.14 seconds decrease in the Timed Up and Go Test (TUG) at week eight compared with baseline. The secondary outcomes included the knee range of motion, the knee extensor and flexor muscle strength, Lequesne index, 9-step stair-climb test (9-SCT), and TUG. Results. Of 30 patients allocated to two groups, 27 (90%) completed the study. The proportion of responders was 53.3% (8 of 15) for electroacupuncture group and 26.7% (4 of 15) for sham electroacupuncture group by the intention-to-treat analysis (P=0.264). There was no statistically significant difference in TUG between the two groups at eight weeks (P=0.856). The compliance rate measured according to patients who conformed to the protocol and had received treatments ≥20 times was 93.3% (28 of 30). The dropout rate was 20% (3 of 15). Adverse effects were not reported in the study. Conclusion. Our research demonstrated that further evaluation of the effectiveness of electroacupuncture versus sham electroacupuncture was feasible and safe for patients with KOA. Whether or not the electroacupuncture can improve the physical functions of knee joint, expand the knee range of motion, and increase the extensor and flexor muscle strength more significantly than sham electroacupuncture, future studies can be designed with larger sample size, randomization design and less biases. This trial is registered with NCT03366363.

scholarly journals Combined ACL and Anterolateral Reconstruction Is Not Associated With a Higher Risk of Adverse Outcomes: Preliminary Results From the SANTI Randomized Controlled Trial

2020 ◽  
Vol 8 (5) ◽  
pp. 232596712091849 ◽  
Author(s):  
Bertrand Sonnery-Cottet ◽  
Charles Pioger ◽  
Thais Dutra Vieira ◽  
Florent Franck ◽  
Charles Kajetanek ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Adverse Events ◽  
Range Of Motion ◽  
Controlled Trial ◽  
Cruciate Ligament ◽  
Adverse Outcomes ◽  
Randomized Controlled ◽  
Increased Risk ◽  
Significant Difference

Background: The widespread historical abandonment of lateral extra-articular procedures in anterior cruciate ligament (ACL) injuries occurred as a result of concerns about high rates of adverse events. Recently, the popularity of lateral extra-articular procedures has resurged, warranting an urgent evaluation of their safety profile. Purpose/Hypothesis: The aim of this study was to perform an interim analysis of the ongoing SANTI randomized controlled trial to determine whether combined ACL and anterolateral ligament reconstruction (ACL + ALLR) is associated with an increased rate of adverse outcomes when compared with isolated ACL reconstruction (ACLR). The hypothesis was that there would be no significant difference between groups at a minimum follow-up of 1 year. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: Recruitment commenced in November 2016. Patients scheduled for ACLR were randomized to either isolated ACLR (with bone–patellar tendon–bone [BPTB] autograft) or combined ACL + ALLR (with hamstring tendon autograft). All patients with a minimum follow-up of 1 year by March 2019 were included. The evaluated parameters included complications and reoperations, knee laxity parameters, range of motion, and scores on the Tegner, Lysholm, International Knee Documentation Committee (IKDC), and Knee injury and Osteoarthritis Outcome Score (KOOS) instruments. Results: A total of 224 patients (112 in each group) with a mean ± SD follow-up of 12.3 ± 1.9 months (range, 12-19 months) formed the study population. A significantly higher rate of reoperation for cyclops syndrome was noted in the isolated ACLR group compared with the combined ACL + ALLR group (8.9% vs 0%, respectively; P = .0012). No significant differences were found in frequency of graft rupture (ACLR, 5.4%; ACL + ALLR, 0.9%; P = .1191), range of motion deficits, pain, or reoperation for meniscectomy between groups. No cases of postoperative infection, venous thromboembolism, or arthrofibrosis were seen. Subjective IKDC (81.2 vs 86.8; P = .0048), Lysholm (88 vs 92; P = .0131), and some components of the KOOS were significantly better in the combined ACL + ALLR group. Conclusion: This study demonstrates no evidence of an increased risk of short-term adverse events after combined ACL + ALLR compared with isolated ACLR with BPTB graft. Registration: NCT03740022 ( ClinicalTrials.gov Identifier)

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