Promoting awareness of donation-related iron depletion among high risk blood donors
BACKGROUND The potential for iron deficiency is a known blood donor health concern and suggests the need to inform donors about the potential risks of low iron levels as well as strategies to address these risks. STUDY DESIGN AND METHODS Frequent (n = 904) and young (n = 629) donors were randomly assigned within risk group to either a control (n = 548) or an intervention (n = 985) group. The control group answered questions at baseline and 6-month follow-up regarding their awareness of the risk of donation-related iron depletion and whether they were taking actions to address their iron status. The intervention group answered the same questions at baseline and follow-up, but after completing the baseline survey, they received information regarding their risk of iron depletion and behaviors they could adopt to mitigate this risk. Intervention group participants were also offered the opportunity to develop an action plan to help them supplement their iron intake. RESULTS The intervention enhanced overall awareness of donation-related iron loss (OR = 1.5, 95% CI 1.171-1.864, p = .001), with no negative impact on retention. Reported iron health behaviors (iron supplementation, speaking with a doctor) showed significant increases when action planning was paired with the educational information. CONCLUSION These findings suggest that it is possible to increase awareness of donation-related risk for iron depletion without negatively influencing retention, and combining education with encouragement to develop an action plan may increase the likelihood of both retention and behavioral changes to promote healthy iron levels.
Frequent or young blood donors (n= 1,533).
Educational information on their risk of iron depletion, advice on how to mitigate against iron loss, encouragement and reminder messages in addition to a baseline and follow-up survey on iron awareness (n= 985).
Baseline and follow-up survey on iron awareness (n= 548).
The intervention enhanced overall awareness of donation-related iron loss (OR = 1.5), with no negative impact on retention. Reported iron health behaviours (iron supplementation, speaking with a doctor) showed significant increases when action planning was paired with the educational information.
Efficacy and Safety of Bioabsorbable Bone Hemostatic Agent in Total Knee Arthroplasty: A Prospective Randomized Controlled Trial
Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis. 2021;27:10760296211023589
Although a bioabsorbable bone hemostatic agent (BBHA) was developed approximately 20 years ago to overcome the shortcomings of conventional bone wax, its bleeding control capacity has not yet been studied. This study was aimed at investigating the efficacy and safety of BBHA in total knee arthroplasty (TKA). Sixty-two patients who underwent unilateral primary TKA for knee osteoarthritis were included and randomized to the control or BBHA group. Before releasing the tourniquet, BBHA was applied on the bone-cut surface that was not covered by implants. The primary variable was the drainage volume during the postoperative period. The secondary outcomes were total estimated blood loss (EBL), hemoglobin level, hematocrit level, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) level, range of motion (ROM), pain visual analog scale (VAS) score, and rate of complications. There were no significant differences in drainage volume or EBL between the 2 groups. Hemoglobin and hematocrit levels were higher in the BBHA group during the 4-week postoperative period; however, the intergroup differences were not significant. The ESR, CRP, ROM, and pain VAS scores in the BBHA group were not significantly different from the corresponding values in the control group. No specific complications were observed. Although BBHA was found to be safe without complications, it did not decrease bleeding after TKA in general cases. Further studies are necessary to evaluate the efficacy of BBHA in patients with coagulation problems.
Safety and efficacy of thalidomide in patients with transfusion-dependent β-thalassemia: a randomized clinical trial
Signal transduction and targeted therapy. 2021;6(1):405
Thalidomide induces γ-globin expression in erythroid progenitor cells, but its efficacy on patients with transfusion-dependent β-thalassemia (TDT) remains unclear. In this phase 2, multi-center, randomized, double-blind clinical trial, we aimed to determine the safety and efficacy of thalidomide in TDT patients. A hundred patients of 14 years or older were randomly assigned to receive placebo or thalidomide for 12 weeks, followed by an extension phase of at least 36 weeks. The primary endpoint was the change of hemoglobin (Hb) level in the patients. The secondary endpoints included the red blood cell (RBC) units transfused and adverse effects. In the placebo-controlled period, Hb concentrations in patients treated with thalidomide achieved a median elevation of 14.0 (range, 2.5 to 37.5) g/L, whereas Hb in patients treated with placebo did not significantly change. Within the 12 weeks, the mean RBC transfusion volume for patients treated with thalidomide and placebo was 5.4 ± 5.0 U and 10.3 ± 6.4 U, respectively (P < 0.001). Adverse events of drowsiness, dizziness, fatigue, pyrexia, sore throat, and rash were more common with thalidomide than placebo. In the extension phase, treatment with thalidomide for 24 weeks resulted in a sustainable increase in Hb concentrations which reached 104.9 ± 19.0 g/L, without blood transfusion. Significant increase in Hb concentration and reduction in RBC transfusions were associated with non β0/β0 and HBS1L-MYB (rs9399137 C/T, C/C; rs4895441 A/G, G/G) genotypes. These results demonstrated that thalidomide is effective in patients with TDT.
Plasma trial: Pilot randomized clinical trial to determine safety and efficacy of plasma transfusions
BACKGROUND Plasma is frequently administered to patients with prolonged INR prior to invasive procedures. However, there is limited evidence evaluating efficacy and safety. STUDY DESIGN AND METHODS We performed a pilot trial in hospitalized patients with INR between 1.5 and 2.5 undergoing procedures conducted outside the operating room. We excluded patients undergoing procedures proximal to the central nervous system, platelet counts <40,000/μl, or congenital or acquired coagulation disorders unresponsive to plasma. We randomly allocated patients stratified by hospital and history of cirrhosis to receive plasma transfusion (10-15 cc/kg) or no transfusion. The primary outcome was change in hemoglobin concentration within 2 days of procedure. RESULTS We enrolled 57 patients, mean age 56.0, 34 (59.6%) with cirrhosis, and mean INR 1.92 (SD = 0.27). In the intention to treat analysis, there were 10 of 27 (38.5%) participants in the plasma arm with a post procedure INR <1.5 and one of 30 (3.6%) in the no treatment arm (p < .01). The mean INR after receiving plasma transfusion was -0.24 (SD 0.26) lower than baseline. The change from pre-procedure hemoglobin level to lowest level within 2 days was -0.6 (SD = 1.0) in the plasma transfusion arm and -0.4 (SD = 0.6) in the no transfusion arm (p = .29). Adverse outcomes were uncommon. DISCUSSION We found no differences in change in hemoglobin concentration in those treated with plasma compared to no treatment. The change in INR was small and corrected to less than 1.5 in minority of patients. Large trials are required to establish if plasma is safe and efficacious.
Patients with cirrhosis (n= 57).
Plasma transfusion (n= 27).
No transfusion (n= 30).
In the intention to treat analysis, there were 10 of 27 (38.5%) participants in the plasma arm with a post procedure INR <1.5 and one of 30 (3.6%) in the no treatment arm. The mean INR after receiving plasma transfusion was -0.24 (SD 0.26) lower than baseline. The change from pre-procedure haemoglobin level to lowest level within 2 days was -0.6 (SD = 1.0) in the plasma transfusion arm and -0.4 (SD = 0.6) in the no transfusion arm. Adverse outcomes were uncommon.
Effect of different operation time on surgical effect and quality of life in patients with severe hypertensive intracerebral hemorrhage
American journal of translational research. 2021;13(8):9538-9545
OBJECTIVE To investigate the effect of different operation time on the surgery effect and quality of life of patients with severe hypertensive cerebral hemorrhage. METHODS A total of 98 patients with severe hypertensive cerebral hemorrhage were selected in this prospective study. According to the random number table, 98 patients were divided into group A and group B. About 47 patients in group A received surgical treatment within 6 hours after onset of a cerebral hemorrhage and 51 patients in group B received surgical treatment within 6-24 hours after onset of a cerebral hemorrhage. The effect of the operation, quality of life (the World Health Organization Quality of Life Scale Brief Version, WHOQOL-BREF) score, neuro function (National Institute of Health stroke scale, NIHSS), the ability of daily living (Barthel index), athletic ability (Fugl-Meyer motor function score), complications and prognosis (GOS) were compared between the two groups. RESULTS The total effective rate of operation in group A (91.49%) was higher than that in group B (76.47%), and the incidence of complications (8.70%) was lower than that in group B (27.08%; all P<0.05). NIHSS score of group A was lower than that of group B, and the WHOQOL-BREF score was higher than that of group B three months after the operation (all P<0.05). Barthel Index and Fugl-Meyer motor function scores of group A were higher than those of group B three months after the operation (all P<0.05). The prognosis of group A was better than group B three months after the operation (P<0.05). CONCLUSION Operation performed within 6 hours after the onset of cerebral hemorrhage is useful in the treatment of severe hypertensive intracerebral hemorrhage. It can effectively improve patients' neurological function, the ability of daily living and motor function without increasing complications and, the quality of life, as well as the prognosis of patients.
Incidence of venous thromboembolism and hemorrhage in Chinese patients after pulmonary lobectomy: mechanical prophylaxis or mechanical prophylaxis combined with pharmacological prophylaxis: a randomized controlled trial
Annals of translational medicine. 2021;9(18):1478
BACKGROUND Venous thromboembolism (VTE) and postoperative bleeding are important complications of lung resection surgery. We investigated the preventive effect of mechanical prophylaxis versus pharmacological prophylaxis after lobectomy, and evaluated the effect of both on the incidence of hemorrhagic events. METHODS A prospective study of 424 lobectomies with moderate to high risk of VTE (Caprini risk score <5) in a single center was performed from April 2020 to March 2021. Patients were 1:1 randomly allocated to mechanical prophylaxis or to the low-molecular-weight heparin (LMWH)-combination-prophylaxis. The incidence of postoperative thrombotic and bleeding events and relevant factors of the two groups were analyzed. RESULTS A total of 410 participants, with 202 and 208 in the mechanical prophylaxis and LMWH-combination-prophylaxis groups respectively, were selected for analysis. Both groups had similar baseline and clinical characteristics. There were no cases of VTE or major bleeding during the study, but the incidence rate of minor bleeding in the LMWH-combination-prophylaxis group was significantly higher than mechanical prophylaxis group [odds ratio (OR) 0.035, 95% confidence interval (CI): 0.011-0.113]. CONCLUSIONS A case-by-case risk assessment of VTE and hemorrhage remains necessary to determine the most appropriate method of thrombosis prophylaxis for patients undergoing pulmonary surgery. Mechanical prophylaxis may be preferable for lung cancer patients with moderate to high risk of VTE (Caprini risk score <5) undergoing lobectomy. TRIAL REGISTRATION Chinese Clinical Trial Registry ChiCTR2100051073.
Artificial Dermis and Autologous Platelet-Rich Plasma for Treatment of Refractory Wounds: A Clinical Study
The international journal of lower extremity wounds. 2021;:15347346211050710
Refractory wounds present a complex and serious clinical dilemma in plastic and reconstructive surgery. However, there are currently no standard guidelines for the treatment of refractory wounds. Artificial dermis (AD) has achieved some satisfactory results, but also has some limitations. Autologous platelet-rich plasma (PRP), as a cell-therapy material, was a valuable and safe treatment dressing for chronic non-healing wounds. This study aimed to evaluate the efficacies of artificial dermis (AD) with and without autologous platelet-rich plasma (PRP) in patients with refractory wounds. Sixteen patients with refractory wounds were randomly allocated to autologous PRP therapy combined with artificial dermis (PRP + AD [N = 8]) or an artificial dermis program only (AD [N = 8]). We compared the efficacies of the two methods in terms of times to wound healing, infection control, and AD vascularization, as well as hospitalization days and eventual clinical outcomes.13 patients achieved complete healing, including seven (87.5%) in the PRP + AD group and six (75.0%) in the AD group (P > .05). The times to wound healing, infection control, and AD vascularization, and hospitalization time after transfer were significantly shorter in the PRP + AD group compared with the AD group (P < .05). In conclusion, the combination of AD and PRP promoted refractory wound healing and shortened waiting times compared with simple dermal grafts.
[Randomized controlled multicenter study of albumin replacement therapy in septic shock (ARISS)]
Der Anaesthesist. 2021
A preliminary study of influences of hydroxyethyl starch combined with ulinastatin on degree of edema in newborns with capillary leak syndrome
American journal of translational research. 2021;13(4):2626-2634
OBJECTIVE To analyze the efficacy of hydroxyethyl starch (HES) combined with Ulinastatin (Uti) in the treatment of newborns with capillary leak syndrome (CLS). METHODS A total of 60 newborns with CLS admitted to four hospitals were selected as the study subjects, and were randomly divided into the control group (n = 30) and the observation group (n = 30) in accordance with the random number table. The control group was treated with HES alone, while the observation group was treated with Uti combined with HES. RESULTS At 5 d after treatment, the incidence rates of systemic edema and pulmonary edema, the levels of CRP, NE, and BUN, and the duration for the improvement of systemic edema, pulmonary edema and NICU hospital stay in the control group were superior to those in the observation group, while the 24-h urine output, PaO(2) and MAP levels, the levels of A, SCr, ALT, and IL-10 in the observation group were superior to those in the control group (P < 0.05). After 3 months of follow-up after treatment, the mortality rate of newborns in the observation group (13.33%) was lower than that in the control group (36.67%) (P < 0.05). CONCLUSION HES combined with Uti can effectively alleviate edema, control inflammatory levels, and improve hepatic and renal functions and neonatal survival rate of newborns with CLS.
Application of enhanced recovery after surgery in total knee arthroplasty in patients with haemophilia A: A pilot study
Nursing open. 2021;8(1):80-86
AIM: To identify the effect of enhanced recovery after surgery (ERAS) and rapid rehabilitation concepts on the outcomes of patients with haemophilia A undergoing total knee arthroplasty. DESIGN Randomized controlled trial. METHODS The primary endpoint was postoperative hospital stay. The secondary endpoints were pain scores, joint function scores, haemoglobin levels at 3 and 7 days after surgery and satisfaction with hospitalization. RESULTS Thirty-two patients were enrolled. Compared with the routine nursing group, the ERAS group showed shorter postoperative hospital stay (14.2 SD 0.8 vs. 16.6 ± 1.3 days, p < .001), smaller amounts of blood transfusion (924 SD 317 vs. 1,263 SD 449 ml, p = .020) and coagulation factors (37,325 SD 5,996 vs. 48,475 SD 8,019 U, p < .001), lower pain scores at 3 (3.3 SD 0.7 vs. 4.3 SD 0.7, p = .002) and 7 (2.3 SD 0.7 vs. 2.8 ± 0.5, p = .015) days, lower hospital for special surgery knee scores at 3 (59.9 SD 7.8 vs. 53.6 SD 5.9, p = .016) and 7 (77.9 SD 6.9 vs. 71.1 ± 7.1, p = .009) days and higher satisfaction with hospitalization (94.3 SD 1.4 vs. 92.7 SD 1.6, p = .004).