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Maternal Fatigue after Postpartum Anemia Treatment with Intravenous Ferric Carboxymaltose vs. Intravenous Ferric Derisomaltose vs. Oral Ferrous Sulphate: A Randomized Controlled Trial
Bombač Tavčar, L., Hrobat, H., Gornik, L., Preložnik Zupan, I., Vidmar Šimic, M., Pečlin, P., Kavšek, G., Lučovnik, M.
Journal of clinical medicine. 2024;13(3)
Abstract
(1) Background: Postpartum anemia is a common maternal complication and is recognized as a cause of impaired quality of life, reduced cognitive abilities, and fatigue. Efficient iron supplementation for the treatment of postpartum anemia is an essential component of high-quality maternal care. The optimal mode of iron supplementation has not been determined yet, whether oral or intravenous. The objective of this study was to compare postpartum anemia treatment with intravenous ferric carboxymaltose, intravenous ferric derisomaltose, and oral ferrous sulfate. (2) Methods: A single-center, open-label, randomized controlled trial. Women with hemoglobin < 100 g/L within 48 h postpartum were randomly allocated to receive intravenous ferric carboxymaltose, intravenous ferric derisomaltose, or oral ferrous sulfate. Intravenous iron was given in one or two doses, while ferrous sulfate was given as two 80 mg tablets once daily. The primary outcome was maternal fatigue measured by the Multidimensional Fatigue Inventory (MFI) six weeks postpartum. Hemoglobin, ferritin, and transferrin saturation levels were analyzed as secondary outcomes. A Kruskal-Wallis test was used for group comparison (p < 0.05 significant). (3) Results: Three hundred women were included. The MFI score at six weeks postpartum did not differ between groups (median 38 (inter-quartile range (IQR) 29-47) in the ferric carboxymaltose group, median 34 (IQR 26-42) in the ferric derisomaltose group, and median 36 (IQR 25-47) in the ferrous sulfate group; p = 0.26). Participants receiving oral iron had lower levels of hemoglobin (135 (131-139) vs. 134 (129-139) vs. 131 (125-137) g/L; p = 0.008), ferritin (273 (198-377) vs. 187 (155-246) vs. 24 (17-37) µg/L; p < 0.001) and transferrin saturation (34 (28-38) vs. 30 (23-37) vs. 24 (17-37) %; p < 0.001) than those receiving ferric carboxymaltose or ferric derisomaltose. (4) Conclusions: Intravenous ferric carboxymaltose, intravenous ferric derisomaltose, and oral ferrous sulfate had similar impacts on maternal fatigue at six weeks postpartum despite improved laboratory parameters in the intravenous groups.
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Subcutaneous marzeptacog alfa (activated) for on-demand treatment of bleeding events in subjects with haemophilia A or B with inhibitors
Faraj, A., Nyberg, J., Blouse, G. E., Knudsen, T., Simonsson, U. S. H.
Clinical pharmacology and therapeutics. 2024
Abstract
Marzeptacog alfa (MarzAA) is under development for subcutaneous treatment of episodic bleeds in hemophilia A/B patients and was studied in a Phase 3 trial evaluating MarzAA compared to standard-of-care (SoC) for on-demand use. The work presented here aimed to evaluate MarzAA and SoC treatment of bleeding events on a standardized 4-point efficacy scale (poor, fair, good and excellent). Two continuous-time Markov modeling approaches were explored; a four-state model analyzing all four categories of bleeding improvement and a two-state model analyzing a binarized outcome (treatment failure [poor/fair], and treatment success [good/excellent]). Different covariates impacting improvement of bleeding episodes as well as a putative relationship between MarzAA exposure and improvement of bleeding episodes were evaluated. In the final four-state model, higher baseline diastolic blood pressure and higher age (>33 years of age) were found to negatively and positively impact improvement of bleeding condition, respectively. Bleeding events occurring in knees and ankles were found to improve faster than bleeding events at other locations. The covariate effects had most impact on early treatment success (=<3 hours) whereas at later timepoints (>12 hours), treatment success was similar for all patients indicating that these covariates might be clinically relevant for early treatment response. A statistically significant relationship between MarzAA zero-order absorption and improvement of bleedings (p< 0.05) were identified albeit with low precision. No statistically significant difference in treatment response between MarzAA and intravenous SoC was identified, indicating the potential of MarzAA for treatment of episodic bleeding events with a favorable subcutaneous administration route.
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Comparison of suture and sutureless techniques on postoperative complications after third molar surgery: a systematic review
Falci, S. G. M., Guimarães, MtbÁ, Canarim, N. M., Falci, S. E., Martins, O. B. L., de Souza, G. M., Galvão, E. L.
Clinical oral investigations. 2024;28(1):115
Abstract
OBJECTIVE To compare, among patients undergoing third molar surgeries, whether the use or omission of sutures improves postoperative clinical parameters. METHOD A systematic literature review was conducted to identify randomized clinical trials in humans. The steps of this review were conducted following the PRISMA protocol. The risk of bias assessment was performed using the revised Cochrane tool (RoB 2). The RevMan software was employed for meta-analyses, and the quality of evidence was evaluated using GRADE. RESULT A total of seven articles were included in the systematic review; however, only one article quantitatively measured bleeding, rendering meta-analysis for this outcome unfeasible. The group of patients in whom sutures were not used presented lower pain and edema on the first day (respectively: MD - 1.08; 95% CI - 1.35 to - 0.81; MD - 1.23; 95% CI - 2.34 to - 0.11) and second day (respectively: MD - 0.50; 95% CI - 0.83 to - 0.17; MD - 10.66; 95% CI - 1.16 to - 0.16) postoperatively, compared to the group where sutures were employed. The group of patients who received sutures exhibited increased trismus on the first day postoperatively (MD 1.04; 95% CI 0.67 to 1.41). CONCLUSION The omission of postoperative sutures in third molar surgeries appears to favor pain and edema outcomes within the first 24 h after the procedure, as well as trismus within the same timeframe. CLINICAL RELEVANCE Despite the suture being the standard conduct in tooth extractions. The omission of sutures in third molar extractions may favor inflammatory outcomes of pain, edema, and trismus in the immediate postoperative period.
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Comparative Analysis of Hemostatic Efficacy: Local Application of Lancehead Snake Venom Thrombin versus Hemostatic Forceps in Colon Polypectomy
Chen, D., Kou, J., Zhang, J.
Alternative therapies in health and medicine. 2024
Abstract
BACKGROUND Colon polypectomy often involves managing bleeding, and the choice of hemostatic methods is critical for patient outcomes. This study addresses the hemostatic effects of lancehead snake venom thrombin compared to hemostatic forceps in the context of colon polypectomy. OBJECTIVE To compare and assess the effectiveness and safety of local application of lancehead snake venom thrombin and hemostatic forceps in achieving hemostasis during colon polypectomy. DESIGN A randomized controlled trial was conducted to investigate and compare the hemostatic outcomes of two different approaches in colon polypectomy. SETTING The study was conducted at the Affiliated Hospital of Hebei University Hospital from January 2022 to June 2022. PARTICIPANTS A total of 80 patients with colon polyps who met the inclusion criteria were randomly assigned to either the lancehead snake venom thrombin group or the hemostatic forceps group. INTERVENTIONS In the hemostatic forceps group, hemostatic forceps were employed to seal the wound post-polyp resection. In the lancehead snake venom thrombin group, aluminium potassium sulfate gel, in conjunction with locally sprayed lancehead snake venom thrombin, was applied to the wound. PRIMARY OUTCOME MEASURES The study assessed (1) intraoperative immediate bleeding and hemostasis; (2) intraoperative hemostasis time; (3) postoperative delayed post-polypectomy bleeding (DPPB); and (4) adverse reactions as primary outcome measures. RESULTS No significant differences were observed in the incidence rate of intraoperative immediate bleeding and the success rate of intraoperative hemostasis between the two groups. The lancehead snake venom thrombin group exhibited a shorter intraoperative hemostasis time and a lower incidence rate of adverse reactions compared to the hemostatic forceps group. No significant difference was found in the incidence rate of postoperative DPPB between the two groups. CONCLUSION Local application of lancehead snake venom thrombin proves to be more effective and safer than hemostatic forceps in promptly managing bleeding during colon polypectomy.
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The effect of the use of tranexamic acid in percutaneous nephrolithotomy on blood loss and surgical visual clarity: a prospective, randomized, controlled and double-blind study
Caliskan, B., Sinan, H., Çağlar, U., Şen, Ö, Akbulut, M. F.
Urolithiasis. 2024;52(1):20
Abstract
Tranexamic acid, once a randomly used antifibrinolytic agent, has been in standard protocols for many specific surgeries. Studies are still needed to standardize the dose and route of tranexamic acid administration, examine its possible contributions in urological surgery, and establish a protocol for its use. To contribute to this goal, we designed a prospective, randomized, double-blind study on 75 patients with 1 control and 2 study groups (n = 25) who underwent percutaneous nephrolithotomy. Group Tranexamic acid received 10 mg/kg intravenous tranexamic acid preoperatively. And Group Irrigation received the same amount in the initial irrigation fluid. Primarily, we observed the total amount of blood transfusion and the changes in hemoglobin and hematocrit values during 2 postoperative days. Distinctively, we intraoperatively monitored hemoglobin continuously as a saturation hemoglobin value to assess the timing of the effect of tranexamic acid. Secondarily, we questioned surgical visual clarity with a standard visual score to reveal its contribution to surgical practicality, operative time, and residual fragment quantity. Our results revealed a significant difference in the reduction of hemoglobin and hematocrit change and blood transfusion in both tranexamic acid groups concerning control, especially on the second day (p = 0.003, p = 0.002, p = 0.001). Likewise, surgical visual scores were significantly better in both tranexamic acid groups (p = 0.018). In conclusion, intravenous or local administration of tranexamic acid at a dose of 10 mg/kg will be sufficient to maintain perioperative stability in hemoglobin values, use fewer blood products and provide a better visual advantage for the surgeon intraoperatively.The trial registration number is NCT05947435, and the date of registration is 07/07/2023, retrospectively registered.
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Roxadustat reduces left ventricular mass index compared to rHuEPO in haemodialysis patients in a randomized controlled trial
Tan, W., Wang, X., Sun, Y., Wang, X., He, J., Zhong, L., Jiang, X., Sun, Y., Tian, E., Li, Z., et al
Journal of internal medicine. 2024
Abstract
BACKGROUND Left ventricular hypertrophy (LVH) is highly prevalent in haemodialysis (HD) patients and is associated with an increased risk of death. Roxadustat and recombinant human erythropoietin (rHuEPO, abbreviated as EPO) are the main treatment strategies for renal anaemia in HD patients, but it has not been clear whether there is a difference in their effect on LVH. METHODS In this multi-centre, prospective, randomized trial of 12-month duration, study participants were randomized in a 1:1 ratio to the roxadustat group or the EPO group. The doses of both treatment regimens were adjusted so that the patients had a haemoglobin level of 10.0-12.0 g per dL. The primary study endpoint was the change from baseline to 12 months in the left ventricular mass index (LVMI, g/m(2) ) measured by echocardiography. RESULTS In total, 114 patients were enrolled. The mean age was 50 years, and the median dialysis duration was 33 months. Sixty-one patients were men, and 24 were diabetic. LVMI decreased from 116.18 ± 27.84 to 110.70 ± 25.74 g/m(2) in the roxadustat group. However, it increased from 109.35 ± 23.41 to 114.99 ± 28.46 g/m(2) in the EPO group, with a significant difference in the change in LVMI between the two groups [-5.48 (-11.60 to 0.65) vs. 5.65 (0.74 to 10.55), p < 0.05]. Changes in left ventricular mass, end-diastolic volume and 6-min walk test seemed superior in the roxadustat group. There were no significant differences in other cardiac geometry, biochemical parameters and major adverse cardiovascular events between the two groups. CONCLUSIONS Compared to EPO, roxadustat is more helpful in the regression of LVH in HD patients.
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Missingness matters: a secondary analysis of thromboelastography measurements from a recent prehospital randomized tranexamic acid clinical trial
Donohue, J. K., Iyanna, N., Lorence, J. M., Brown, J. B., Guyette, F. X., Eastridge, B. J., Nirula, R., Vercruysse, G. A., O'Keeffe, T., Joseph, B., et al
Trauma surgery & acute care open. 2024;9(1):e001346
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Editor's Choice
Abstract
BACKGROUND Tranexamic acid (TXA) has been hypothesized to mitigate coagulopathy in patients after traumatic injury. Despite previous prehospital clinical trials demonstrating a TXA survival benefit, none have demonstrated correlated changes in thromboelastography (TEG) parameters. We sought to analyze if missing TEG data contributed to this paucity of findings. METHODS We performed a secondary analysis of the Study of Tranexamic Acid During Air Medical and Ground Prehospital Transport Trial. We compared patients that received TEG (YES-TEG) and patients unable to be sampled (NO-TEG) to analyze subgroups in which to investigate TEG differences. TEG parameter differences across TXA intervention arms were assessed within subgroups disproportionately present in the NO-TEG relative to the YES-TEG cohort. Generalized linear models controlling for potential confounders were applied to findings with p<0.10 on univariate analysis. RESULTS NO-TEG patients had lower prehospital systolic blood pressure (SBP) (100 (78, 140) vs 125 (88, 147), p<0.01), lower prehospital Glascow Coma Score (14 (3, 15) vs 15 (12, 15), p<0.01), greater rates of prehospital intubation (39.4% vs 24.4%, p<0.01) and greater mortality at 30 days (36.4% vs 6.8%, p<0.01). NO-TEG patients had a greater international normalized ratio relative to the YES-TEG subgroup (1.2 (1.1, 1.5) vs 1.1 (1.0, 1.2), p=0.04). Within a severe prehospital shock cohort (SBP<70), TXA was associated with a significant decrease in clot lysis at 30 min on multivariate analysis (β=-27.6, 95% CI (-51.3 to -3.9), p=0.02). CONCLUSIONS Missing data, due to the logistical challenges of sampling certain severely injured patients, may be associated with a lack of TEG parameter changes on TXA administration in the primary analysis. Previous demonstration of TXA's survival benefit in patients with severe prehospital shock in tandem with the current findings supports the notion that TXA acts at least partially by improving clot integrity. LEVEL OF EVIDENCE Level II.
PICO Summary
Population
Patients at risk for haemorrhage receiving tranexamic acid before hospitalization, enrolled in the Study of Tranexamic Acid During Air Medical and Ground Prehospital Transport (STAAMP) Trial (n= 903).
Intervention
Prehospital tranexamic acid (TXA) (n= 447).
Comparison
Placebo (n= 456).
Outcome
This study was a secondary analysis of the STAAMP trial, comparing patients that received thromboelastography (TEG) (YES-TEG, n= 837) and patients unable to be sampled (NO-TEG, n= 66) to analyze subgroups in which to investigate TEG differences. NO-TEG patients had lower prehospital systolic blood pressure (SBP) (100 (78, 140) vs. 125 (88, 147)), lower prehospital Glascow Coma Score (14 (3, 15) vs. 15 (12, 15)), greater rates of prehospital intubation (39.4% vs. 24.4%) and greater mortality at 30 days (36.4% vs. 6.8%). NO-TEG patients had a greater international normalized ratio relative to the YES-TEG subgroup (1.2 (1.1, 1.5) vs. 1.1 (1.0, 1.2)). Within a severe prehospital shock cohort (SBP< 70), TXA was associated with a significant decrease in clot lysis at 30 min on multivariate analysis (β= -27.6; 95% CI [-51.3, -3.9].
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The effect of perioperative sequential application of multiple doses of tranexamic acid on postoperative blood loss after PLIF: A prospective randomized controlled trial
Dong, W., Tang, Y., Lei, M., Ma, Z., Zhang, X., Shen, J., Hao, J., Jiang, W., Hu, Z.
International journal of surgery (London, England). 2024
Abstract
BACKGROUND Tranexamic acid (TXA) has been utilized in spinal surgery to effectively reduce intraoperative blood loss (IBL) and allogeneic blood transfusion rates. However, the traditional TXA regimen might last the entire duration of hyperfibrinolysis caused by surgical trauma, resulting in its limited ability to reduce postoperative blood loss (PBL). Therefore, the aim of this study was to investigate the effectiveness of perioperative sequential administration of multiple doses of TXA in reducing PBL in patients who underwent posterior lumbar interbody fusion (PLIF). METHODS From February 2022 to June 2023, 231 patients who were diagnosed with lumbar degenerative disease and scheduled to undergo PLIF were prospectively enrolled in the present study. The patients were randomly divided into three groups. Moreover, all patients received an intravenous injection of TXA at a dose of 15 mg/kg 15 min before surgical skin incision. Patients in Group A received a placebo of normal saline after surgery, while patients in Group B received three additional intravenous injections of TXA at a dose of 15 mg/kg every 24 h. Patients in Group C received three additional intravenous injections of TXA at a dose of 15 mg/kg every 5 h. The primary outcome measure was PBL. In addition, this study assessed total blood loss (TBL), IBL, routine blood parameters, liver and kidney function, coagulation parameters, fibrinolysis indexes, inflammatory indicators, drainage tube removal time (DRT), length of hospital stay (LOS), blood transfusion rate, and incidence of complications for all subjects. RESULTS The PBL, TBL, DRT, and LOS of Group B and Group C were significantly lower than those of Group A (P<0.05). The level of D-dimer (D-D) in Group C was significantly lower than that in Group A on the first day after the operation (P=0.002), and that in Group B was significantly lower than that in Group A on the third day after the operation (P=0.003). The interleukin-6 levels between the three groups from 1-5 days after the operation were in the order of Group A > Group B > Group C. No serious complications were observed in any patient. The results of multiple stepwise linear regression analysis revealed that PBL was positively correlated with incision length, IBL, smoking history, history of hypertension, preoperative fibrinogen degradation product (FDP) level, and blood transfusion. It was negatively correlated with preoperative levels of fibrinogen (FIB), red blood cells (RBCs), blood urea nitrogen (BUN), and age. Compared to female patients, male patients had an increased risk of PBL. Finally, the incidence of PBL was predicted. CONCLUSIONS Sequential application of multiple doses of TXA during the perioperative period could safely and effectively reduce PBL and TBL, shorten DRT and LOS, reduce postoperative D-D generation, and reduce the postoperative inflammatory response. In addition, this study provided a novel prediction model for PBL in patients undergoing PLIF.
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Oral as compared to intravenous tranexamic acid to limit peri-operative blood loss associated with primary total hip arthroplasty: A randomised noninferiority trial
Piette, N., Beck, F., Carella, M., Hans, G., Maesen, D., Kurth, W., Lecoq, J. P., Bonhomme, V. L.
European journal of anaesthesiology. 2024
Abstract
BACKGROUND Oral as compared to intravenous tranexamic acid (TXA) is an attractive option, in terms of cost and safety, to reduce blood loss and transfusion in total hip arthroplasty. Exclusion criteria applied in the most recent randomised trials may have limited the generalisability of oral tranexamic acid in this indication. Larger and more inclusive studies are needed to definitively establish oral administration as a credible alternative to intravenous administration. OBJECTIVES To assess the noninferiority of oral to intravenous TXA at reducing intra-operative and postoperative total blood loss (TBL) in primary posterolateral approached total hip arthroplasty (PLTHA). DESIGN Noninferiority, single centre, randomised, double-blind controlled study. SETTING Patients scheduled for primary PLTHA. Data acquisition occurred between May 2021 and November 2022 at the University Hospital of Liège, Belgium. PATIENTS Two hundred and twenty-eight patients, randomised in a 1 : 1 ratio from a computer-generated list, completed the trial. INTERVENTIONS Administration of 2 g of oral TXA 2 h before total hip arthroplasty and 4 h after incision (Group oral) was compared to the intravenous administration of 1 g of TXA 30 min before surgery and 4 h after incision (Group i.v.). MAIN OUTCOME MEASURES TBL (measured intra-operative and drainage blood loss up to 48 h after surgery, primary outcome), decrease in haemoglobin concentration, D-Dimer at day 1 and day 3, transfusion rate (secondary outcomes). RESULTS Analyses were performed on 108 out of 114 participants (Group i.v.) and 104 out of 114 participants (Group oral). Group oral was noninferior to Group i.v. with regard to TBL, with a difference between medians (95% CI) of 35 ml (-103.77 to 33.77) within the noninferiority margins. Median [IQR] of estimated TBL was 480 ml [350 to 565] and 445 ml [323 to 558], respectively. No significant interaction between group and time was observed regarding the evolution of TBL and haemoglobin over time. CONCLUSIONS TXA as an oral premedication before PLTHA is noninferior to its intravenous administration regarding peri-operative TBL. TRIAL REGISTRATION European Clinical Trial Register under EudraCT-number 2020-004167-29 (https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-004167-29/BE).
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Roxadustat and Oral Iron Absorption in Chinese Patients with Anemia of Chronic Kidney Disease: A Randomized, Open-Label, Phase 4 Study (ALTAI)
Wu, H., Cheng, H., Wang, C., Yao, L., Qin, S., Zuo, L., Hu, Z., Zhang, C., Wu, Y., Hofherr, A., et al
Advances in therapy. 2024
Abstract
INTRODUCTION Anemia of chronic kidney disease (CKD) has a high incidence and is associated with many disease conditions. Iron dysmetabolism is an important contributor to anemia in CKD patients. METHODS ALTAI, a randomized, active-controlled, phase 4 trial, investigated the efficacy of roxadustat versus recombinant human erythropoietin (rHuEPO) on gastrointestinal iron absorption in patients with anemia of CKD (stage 4/5). The primary endpoint was change from baseline to day 15 in gastrointestinal iron absorption (serum iron area under the concentration-time curve; AUC(0-3h)) following single-dose oral iron. RESULTS Twenty-five patients with a mean age of 55.1 years were randomized 1:1 to roxadustat (n = 13) or rHuEPO (n = 12). Baseline iron profiles were similar between treatment groups. Change from baseline to day 15 in serum iron AUC(0-3h) was not statistically significantly different between the roxadustat and rHuEPO groups. Mean (SD) change from baseline in serum iron AUC(0-3h) was 11.3 (28.2) g × 3 h/dl in the roxadustat group and - 0.3 (9.7) g × 3 h/dl in the rHuEPO group. Roxadustat treatment was associated with decreased hepcidin and also increased transferrin, soluble transferrin receptor, and total iron-binding capacity (TIBC), with nominal significance. The proportion of patients experiencing one or more adverse events was 38.5% when treated with roxadustat and 16.7% with rHuEPO. CONCLUSIONS The study showed no significant difference between roxadustat and rHuEPO in iron absorption but was underpowered because of recruitment challenges. TRIAL REGISTRATION ClinicalTrials.gov Identifier NCT04655027.