Efficacy of packed red blood cell transfusions based on weight versus formula in thalassemic children: An open-label randomized control trial
BACKGROUND Protocols for transfusion therapy in transfusion-dependent thalassemia (TDT) children differ among various medical centers. In India, most centers consider only the patient's weight while calculating the volume of packed red blood cells (PRBCs) to be transfused. This study aimed to compare the efficacy of PRBC transfusions of different volumes calculated either by weight or by a formula using weight and pretransfusion hemoglobin of patient and hematocrit of PRBC. STUDY DESIGN AND METHODS Sixty TDT patients in the age group of 3-9 years were enrolled and randomly allocated to two groups. Group A received PRBC transfusion volume based on the patient's weight, and Group B received PRBC volume calculated using a formula for 6 months. RESULTS Average pretransfusion hemoglobin in Group A and Group B (9 ± 0.4 vs. 8.9 ± 0.4 g/dl) was not significantly different (p = .353). Although the average number of visits in 6 months was less for Group A compared to Group B (7 ± 1 vs. 8 ± 1; p = .001); the average volume transfused per visit was more (351 ± 78 vs. 287 ± 68 ml; p = .003). The calculated average annual pure red cell requirement of the patients was 178 ml/kg/year for Group A and 154 ml/kg/year for Group B (p = .000). Total donor exposures were significantly lower in Group B than Group A (11 ± 3 vs. 14 ± 3; p = .006). CONCLUSION The number of donor exposures and annual pure red cell requirement was significantly lower in the formula-based group. Transfusions based on formula are recommended in TDT patients.
Transfusion-dependent thalassemia children (n= 60).
Packed red blood cells (PRBC) transfusion volume based on the patient’s weight (Group A, n= 30).
PRBC transfusion volume calculated according to a formula based on haematocrit of blood unit, desired rise in patient's haemoglobin, and patient's weight (Group B, n= 30).
The average number of visits in 6 months was less for Group A compared to Group B (7 ± 1 vs. 8 ± 1). The average volume transfused per visit was higher for Group A than Group B (351 ± 78 vs. 287 ± 68 ml). The calculated average annual pure red cell requirement of the patients was 178 ml/kg/year for Group A and 154 ml/kg/year for Group B. The total donor exposures were significantly lower in Group B than Group A (11 ± 3 vs. 14 ± 3).
Epidural anaesthesia and myomectomy-associated blood loss: - a prospective randomised controlled study
Ginekologia polska. 2022
OBJECTIVES The management of anaesthesia for patients with large myomas is particularly important due to disruption of hemodynamic as a result of massive haemorrhage, the prolonged duration of surgery and requirement for additional interventions. This study evaluated the effect of anaesthetic technique on blood loss in patients undergoing myomectomy due to large fibroid uterus. MATERIAL AND METHODS A total of 156 patients that underwent myomectomy were randomized into two equal groups according to the type of anaesthesia: Epidural anaesthesia group and General anaesthesia group. The volume of blood loss and blood products transfusion was reviewed for each patient. RESULTS The intraoperative blood loss and need for blood transfusion were significantly higher in general anaesthesia group (p < 0.001). The mean hematocrit change was 2.5 ± 1.5 vs 3.7 ± 2.9 % (p = 0.001) for both groups. CONCLUSIONS In the myomectomy planning of women with a large fibroid uterus, the team of gynecologists and anaesthesiologists should take care to choose the most optimal technique for anaesthesia.
The safty profile of blood salvage applied for collected blood with amniotic fluid during cesarean section
BMC pregnancy and childbirth. 2022;22(1):160
BACKGROUND The guidelines of National Health Service(NHS, the United Kingdom) recommended for use in obstetrics at increased risk of bleeding, requiring two suction devices to reduce amniotic fluid contamination, however, when comes to massive hemorrhage, it is may difficult to operate because the complex operation may delay time. The aim of the study was to detect the effect of amniotic fluid recovery on intraoperative cell salvage in obstetrics and provide evidence for clinical applications. METHOD Thirty-four patients undergoing elective cesarean section were randomly divided into two groups. In group 1, the cumulative blood from the operation field, including the amniotic fluid, was collected using a single suction device for processing. In group 2, after suctioning away the amniotic fluid using another suction device for the cumulative blood from the operation field. From each group, four samples were taken, including maternal venous blood (sample I), blood before washing (sample II), blood after washing (sample III) and blood after filtration with a leukocyte filter (sample IV), to detect serum potassium (K +), hemoglobin (Hb), white blood cell (WBC), fetal hemoglobin (HbF), alpha fetoprotein (AFP) and squamous cell (SC) levels. RESULTS The AFP, K + and WBC levels of sample III and sample IV were significantly lower than sample I in group 1 and group 2 (P < 0.05). Significantly more SCs were found in sample III than in sample I in group 1 and group 2 (P < 0.05), but SCs of sample IV had no statistical difference compared to sample I in group 1 and group 2 (P > 0.05). There was no significant difference in the K + , Hb, WBC, AFP and SC levels of sample IV between group 1 and group 2 (P > 0.05). The HbF levels of sample III and sample IV were significantly higher in group 1 than in group 2 (P < 0.05). CONCLUSION There is little or no possibility for AF contamination to enter the re-infusion system when used in conjunction with a leucodepletion filter. For maternal with Rh-negative blood, we recommend two suction devices to reduce HbF pollution. TRIAL REGISTRATION ChiCTR1800015684 , 2018.4.15.
Gongning granules plus low dose hormone in pubertal functional uterine hemorrhage: Analysis of hemodynamics and clinical efficacy
Pakistan journal of pharmaceutical sciences. 2022;35(1(Special)):387-392
To evaluate the clinic)al effect of Gongning granules combined with low-dose hormone therapy in pubertal dysfunctional uterine bleeding (PDUB) and its effect on uterine hemodynamics. A total of 164 PDUB patients who were treated in the gynecological outpatient department of our hospital from December 2018 to June 2020 were randomized into study group and control group, with 82 cases each. The control group received estrogen progesterone, and the study group received Gongning granules plus. The clinical efficacy and uterine arterial hemodynamics were compared. The clinical efficacy of the study group was superior to the control group (91.46% vs. 76.83%, P<0.05). The study group yielded shorter bleeding control time and complete hemostasis time than the control group (P<0.05). The amount of menstrual bleeding and duration of menstruation in both groups decreased significantly with time and the study group was significantly lower than the control group (all P<0.05). The endometrial thickness in the study group was significantly thinner than the control group, and the maximum follicle diameter was significantly longer than that in the control group (all P<0.05). After treatment, the platelet count, hemoglobin level of peripheral blood, uterine arterial blood flow and mean flow velocity in the study group were significantly higher than those in the control group (all P<0.05). In addition, there was no significant difference in adverse drug reaction (ADR) between the two groups (P>0.05). In PDUB patients, Gongning granules plus low-dose hormone can significantly relieve bleeding symptoms, improve hemodynamic status and has good safety.
Autologous Cultured Bone Marrow-Derived Mesenchymal Stem Cells in a Fibrin Spray to Treat Venous Ulcers: A Randomized Controlled Double-Blind Pilot Study
Surgical technology international. 2022;40
We treated a small cohort of venous ulcers that were very unresponsive to standard and advanced therapies with autologous cultured bone marrow-derived mesenchymal stem cells (MSCs). This pilot clinical trial was randomized, controlled, and double-blinded. Subjects were treated with either normal saline (Group A), fibrin spray alone (Group B), or MSCs in fibrin (1 million cells/cm2 of wound bed surface) (Group C). The control and test materials were applied to the wound using a double-barreled syringe with thrombin and fibrinogen (with or without MSCs) in each barrel, or saline alone in both barrels. The MSCs were separated, cultured in vitro, and expanded in a dedicated Good Manufacturing Practice (GMP) facility from 30-50 ml of bone marrow aspirate obtained from the iliac crest in Group C subjects. To ensure that the study remained controlled and blinded, subjects who were randomized to one of the two control arms (saline or fibrin) underwent sham bone marrow aspiration performed by a hematologist who anesthetized the iliac crest area down to and pushing against the periosteum, but without penetrating the bone marrow. Therefore, both the clinician who evaluated wound progress and the study subjects had no knowledge of whether bone aspiration was actually performed and what treatment had been applied to the wound. The study was performed after full FDA investigational new drug (IND) approval. The primary endpoint was the rate of healing (wound closure as linear healing from the wound margins in cm/week), as measured by the Gilman equation. One-way ANOVA was used to calculate the statistical significance of differences between the mean healing rates of each of the 3 treatment groups every 4 weeks and over the 24 weeks of treatment. Overall, treatment with MSCs accelerated the healing rate by about 10-fold compared to those in the saline and fibrin control groups. Although the total number of patients in this pilot study was small (n=11), the statistical significance was surprisingly promising: p<0.01 and f-ratio of 15.9358. No serious adverse events were noted. This small but carefully performed prospective, controlled, randomized, and double-blinded pilot study in a rare population of totally unresponsive patients adds to previous reports showing the promise of MSCs in the treatment of chronic wounds and provides proof of principle for how to approach this type of very demanding clinical and translational research.
Comparison of the effects of calcium channel blockers plus iron chelation therapy versus chelation therapy only on iron overload in children and young adults with transfusion-dependent thalassemia: A randomized double-blind placebo-controlled trial
Pediatric blood & cancer. 2022;:e29564
BACKGROUND Myocardial iron deposition is a significant cause of morbidity and mortality in patients with transfusion-dependent thalassemia (TDT). Amlodipine, L-type calcium channel blocker with regular chelation therapy may reduce myocardial iron overload. Lack of randomized trials prompted this study to assess the effect of calcium channel blocker (amlodipine) in combination with iron chelation therapy on iron overload in patients with TDT. METHODS Sixty-four eligible patients were randomized to receive either amlodipine and chelation (group A) or chelation alone (group B) in double-blind placebo-controlled trial. Myocardial iron concentration (MIC) using T2* magnetic resonance imaging (MRI), liver iron concentration (LIC), left ventricular ejection fraction (LVEF), and serum ferritin were measured at baseline and 12 months. RESULTS In the amlodipine group, mean cardiac T2* value significantly increased from 18.11 ± 8.47 to 22.15 ± 7.61 (p = .002) at 12 months, whereas in control group, there was a nonsignificant increase (p = .62) in cardiac T2* value from 19.50 ± 8.84 to 20.03 ± 9.07. There was a significant decrease in MRI-derived MIC in the amlodipine group compared to control group (1.93 ± 1.61 to 1.29 ± 0.90, p = .01). Changes in the LVEF (p = .45), MRI-derived LIC (p = .09), and serum ferritin (p = .81) were not significant between the two groups. CONCLUSION Amlodipine is safe and when combined with chelation therapy appears to be more effective in reducing cardiac iron overload than chelation only in children and young adults with TDT.
Evaluation of the effects of platelet-rich fibrin, concentrated growth factors, and autologous fibrin glue application on wound healing following gingivectomy and gingivoplasty operations: a randomized controlled clinical trial
Quintessence international (Berlin, Germany : 1985). 2022;53(4):328-341
OBJECTIVE The aim of this study was to evaluate the effect of platelet-rich fibrin (PRF), concentrated growth factors (CGF), and autologous fibrin glue (AFG) application on early wound healing after gingivectomy and gingivoplasty operations. METHOD AND MATERIALS In this split-mouth study, gingivectomy and gingivoplasty surgery were performed on 19 patients. The postoperative PRF, CGF, and AFG applied areas were compared with the control regions. On days 0, 7, 14, and 28, the surgical area was stained with a plaque-disclosing agent and evaluated in the ImageJ program. Wound healing was evaluated with H2O2 test, visual analog scale for pain, and Landry, Turnbull, and Howley (LTH) wound healing index on days 7, 14, and 28. The patients were asked to evaluate their esthetic perceptions on a visual analog scale. RESULTS The amount of staining at days 7 and 14 was found to be significantly higher in the control group than in the test groups, but there was no difference between the test groups. LTH index values of the control group at days 7, 14, and 28 were found to be significantly lower than the test groups. There was no significant difference between the groups in the epithelialization assessment performed with the H2O2 test. It was observed that the use of platelet concentrate at day 7 reduced postoperative early pain. Patients were highly satisfied with postoperative esthetics. CONCLUSION After gingivectomy and gingivoplasty operations, PRF, CGF, and AFG application were found to have positive effects on wound healing. However, PRF, CGF, and AFG applications were not superior to each other in terms of secondary wound healing.
Randomized trial of three IVIg doses for treating chronic inflammatory demyelinating polyneuropathy
Brain : a journal of neurology. 2022
Intravenous immunoglobulin treatment for chronic inflammatory demyelinating polyneuropathy usually starts with a 2.0 g/kg induction dose followed by 1.0 g/kg maintenance doses every 3 weeks. No dose-ranging studies with intravenous immunoglobulin maintenance therapy have been published. The Progress in Chronic Inflammatory Demyelinating polyneuropathy (ProCID) study was a prospective, double-blind, randomised, parallel-group, multicentre, phase III study investigating the efficacy and safety of 10% liquid intravenous immunoglobulin (panzyga®) in patients with active chronic inflammatory demyelinating polyneuropathy. Patients were randomised 1:2:1 to receive the standard intravenous immunoglobulin induction dose and then either 0.5, 1.0 or 2.0 g/kg maintenance doses every 3 weeks. The primary endpoint was the response rate in the 1.0 g/kg group, defined as an improvement ≥ 1 point in adjusted Inflammatory Neuropathy Cause and Treatment score at Week 6 versus baseline and maintained at Week 24. Secondary endpoints included dose response and safety. This trial was registered with EudraCT (Number 2015-005443-14) and clinicaltrials.gov (NCT02638207). Between August 2017 and September 2019, the study enrolled 142 patients. All 142 were included in the safety analyses. As no post infusion data were available for three patients, 139 were included in the efficacy analyses, of whom 121 were previously on corticosteroids. The response rate was 80% (55/69 patients) (95% confidence interval: 69-88%) in the 1.0 g/kg group, 65% (22/34; confidence interval: 48-79%) in the 0.5 g/kg group, and 92% (33/36; confidence interval 78-97%) in the 2.0 g/kg group. While the proportion of responders was higher with higher maintenance doses, logistic regression analysis showed that the effect on response rate was driven by a significant difference between the 0.5 and 2.0 g/kg groups, whereas the response rates in the 0.5 and 2.0 g/kg groups did not differ significantly from the 1.0 g/kg group. Fifty-six percent of all patients had an adjusted Inflammatory Neuropathy Cause and Treatment score improvement 3 weeks after the induction dose alone. Treatment-related adverse events were reported in 16 (45.7%), 32 (46.4%) and 20 (52.6%) patients in the 0.5, 1.0 and 2.0 g/kg dose groups, respectively. The most common adverse reaction was headache. There were no treatment-related deaths. Intravenous immunoglobulin 1.0 g/kg was efficacious and well tolerated as maintenance treatment for patients with chronic inflammatory demyelinating polyneuropathy. Further studies of different maintenance doses of intravenous immunoglobulin in chronic inflammatory demyelinating polyneuropathy are warranted.
The impact of pathogen-reduced platelets in acute leukaemia treatment on the total blood product requirement: a subgroup analysis of an EFFIPAP randomised trial
Transfusion medicine (Oxford, England). 2022
OBJECTIVE To evaluate the impact of pathogen-reduced (PR) platelet transfusions on blood products requirement for clinical practice. BACKGROUND PR platelets are increasing in use as standard blood products. However, few randomised trials have evaluated their impact on bleeding control or prevention. Furthermore, PR platelets recirculate less than untreated platelets. METHODS A subgroup study of the randomised clinical trial EFFIPAP compared three arms of platelet preparations (PR: P-PRP/PAS, additive solution: P-PAS and plasma P-P arms respectively). The subgroup of acute leukaemia patients, in their chemotherapy induction phase, included 392 patients (133 P-PRP/PAS arm, 132 P-PAS arm and 130 P-P arm). Blood requirements were analysed across over periods of 7 days. RESULTS The number of platelet transfusions per week was significantly higher in the P-PRP/PAS group 2.3 [1.6-3.3] compared to the control groups 1.9 [1.3-2.8] and 2.0 [1.3-3.0] for P-P and P-PAS groups respectively (p < 0.0001). However, the total number of platelets transfused per week was not different. The number of red blood cell concentrates (RBC) transfusion per week did not differ either. CONCLUSION In a homogeneous group of patients, platelet pathogen reduction resulted in an increased number of platelet units transfused per week while having no impact on the total number of platelets transfused or the number of RBC transfusion; resulting to an average requirement of 2 RBC and 2-3 platelets transfusions per week of marrow aplasia.
Effect of an "Autogenous Leukocyte Platelet-Rich Fibrin Tooth Graft" Combination around Immediately Placed Implants in Periodontally Compromised Sites: A Randomized Clinical Trial
International journal of dentistry. 2022;2022:4951455
OBJECTIVE Autogenous tooth bone graft (ATBG) was suggested as a source for bone grafting materials, especially as they have similar chemical composition to bone. This study goal was to assess the clinical and radiographic consequences of ATBG with or without L-PRF on bone deposition around immediate implants placed in periodontally hopeless sites. MATERIALS AND METHODS 26 patients, with periodontally diseased teeth, underwent random assignment to receive the surgical protocol either with L-PRF over ATBG around immediately inserted implants (test group) or without it (control group). Clinical examination was observed. Radiographically, bone changes horizontally and vertically to determine marginal bone loss (MBL) and mesiodistal bone changes were made at the base line and 6 and 9 months after implant insertion. Statistical analysis utilizing paired Student's t-test was used for comparing results within the same group, whereas an independent-sample t-test was used for intergroup variable comparison. RESULTS All implants met the criteria of success without any complications at the follow-up period. Nonsignificant differences were detected between horizontal bone alterations in both groups at 6 and 9 months (P > .001). The test group showed statistically significant lower MBL than the control group (P < .001). The mesiodistal bone gain in the test group was significantly higher than that of the control group at the 6-month period (P < .001). The mesiodistal bone loss in the control group was significantly higher than that of the test group at the 9-month period (P < .001). CONCLUSION The ATBG- L-PRF combination therapy enhances new bone formation and appeared to be a favorable procedure with immediate implant placement, particularly in severe periodontitis cases.