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Orthopaedic Trauma and Anemia: Conservative versus Liberal Transfusion Strategy: A Prospective Randomized Study
Mullis, B. H., Mullis, L. S., Kempton, L. B., Virkus, W., Slaven, J. E., Bruggers, J.
Journal of orthopaedic trauma. 2024;38(1):18-24
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Editor's Choice
Abstract
OBJECTIVES To determine whether it is safe to use a conservative packed red blood cell transfusion hemoglobin (Hgb) threshold (5.5 g/dL) compared with a liberal transfusion threshold (7.0 g/dL) for asymptomatic musculoskeletal injured trauma patients who are no longer in the initial resuscitative period. METHODS Design: Prospective, randomized, multicenter trial. SETTING Three level 1 trauma centers. PATIENT SELECTION CRITERIA Patients aged 18-50 with an associated musculoskeletal injury with Hgb less than 9 g/dL or expected drop below 9 g/dL with planned surgery who were stable and no longer being actively resuscitated were randomized once their Hgb dropped below 7 g/dL to a conservative transfusion threshold of 5.5 g/dL versus a liberal threshold of 7.0 g/dL. OUTCOME MEASURES AND COMPARISONS Postoperative infection, other post-operative complications and Musculoskeletal Functional Assessment scores obtained at baseline, 6 months, and 1 year were compared for liberal and conservative transfusion thresholds. RESULTS Sixty-five patients completed 1 year follow-up. There was a significant association between a liberal transfusion strategy and higher rate of infection (P = 0.01), with no difference in functional outcomes at 6 months or 1 year. This study was adequately powered at 92% to detect a difference in superficial infection (7% for liberal group, 0% for conservative, P < 0.01) but underpowered to detect a difference for deep infection (14% for liberal group, 6% for conservative group, P = 0.2). CONCLUSIONS A conservative transfusion threshold of 5.5 g/dL in an asymptomatic young trauma patient with associated musculoskeletal injuries leads to a lower infection rate without an increase in adverse outcomes and no difference in functional outcomes at 6 months or 1 year. LEVEL OF EVIDENCE Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.
PICO Summary
Population
Musculoskeletal trauma patients with planned surgery (n= 99).
Intervention
Liberal transfusion threshold of 7.0 g/dL (n= 49).
Comparison
Conservative transfusion threshold of 5.5 g/dL (n= 50).
Outcome
Overall, 46/49 (93.9%) of the liberal group had a transfusion versus 23/50 (46.0%) of the conservative group had a transfusion after resuscitation and after enrollment in this study. Following resuscitation and enrollment in the study, patients in the liberal group received a median of 1 unit of blood transfused (range 0–12) and patients in the conservative group received a median of 0 units of blood (range 0–14). Sixty-five patients completed 1- year follow-up. There was a significant association between a liberal transfusion strategy and higher rate of infection, with no difference in functional outcomes at 6 months or 1 year.
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Effectiveness of a polycaprolactone scaffold combined with platelet-rich fibrin as guided tissue regeneration materials for preserving an implant-supported overdenture
Mohamed Abdel-Aziz, L., Abdallah, S. A., Mohammed Bakr, N., Bahaa, S. M., Zainalabdeen, E. H., Alsharif, M., Elsayed, S. A.
The Saudi dental journal. 2024;36(1):151-157
Abstract
OBJECTIVES This study aimed to assess the effectiveness of ridge preservation using a polycaprolactone (PCL) scaffold combined with platelet-rich fibrin (PRF) to promote bone regeneration before implantation. MATERIALS AND METHODS This prospective study was conducted at Al-Azhar University in Egypt. It included 30 participants requiring the extraction of their last mandibular premolar before constructing an implant-supported overdenture. The participants were divided into three groups: Group A was treated with a PCL scaffold and PRF as ridge preservative materials, Group B was treated with PRF alone, and Group C (control) was treated with no preservative material. Bone samples were collected for histomorphometric analysis at implant placement. RESULTS The participants' mean age was 65.3 ± 4.27 years, and 18 (60%) were male. Postoperative alveolar bone lengths differed significantly between Groups A and B (P = 0.001). However, alveolar bone width changes did not differ significantly among groups. In contrast, the postoperative bone density and loss differed significantly among groups (P = 0.001). CONCLUSION Combining two ridge preservation techniques (PCL and PRF) enhanced participants' alveolar bone remodelling by decreasing its resorption and maintaining its width.
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Red cell transfusion thresholds in outpatients with myelodysplastic syndromes: Results of a pilot randomized trial RBC-ENHANCE
Buckstein, R., Callum, J., Prica, A., Bowen, D., Wells, R. A., Leber, B., Heddle, N., Chodirker, L., Cheung, M., Mozessohn, L., et al
Transfusion. 2024
Abstract
BACKGROUND The optimal hemoglobin (Hb) threshold for red blood cell transfusions in adult patients with myelodysplastic syndromes (MDS) has not been defined. STUDY DESIGN AND METHODS We conducted a pilot randomized multi-center study of two transfusion algorithms (liberal, to maintain Hb 110-120 g/L, transfuse 2 units if Hb < 105 g/L and 1 unit if Hb 105-110 g/L vs. restrictive, 85-105 g/L, transfuse 2 units when Hgb < 85 g/L). Primary objectives were 70% compliance in maintaining the q2 week hemoglobin within the targeted range and the achievement of a 15 g/L difference in pre-transfusion Hb. Secondary outcomes included measures of quality of life (QOL), iron studies and safety. RESULTS Twenty-eight patients were randomized between February 2015-2020, 13 to the restrictive arm and 15 to the liberal arm in three tertiary care centers. The compliance was 66% and 45% and the mean pre-transfusion Hb thresholds were 86 (standard deviation [SD] 8) and 98 g/L (SD 10) in the restrictive and liberal arms, (mean difference 11.8 g/L, p < .0001), respectively. Patients in the liberal arm experienced a mean of 3.4 (SD 2.6) more transfusion visits and received a mean of 5.3 (SD 5.5) more units of blood during the 12-week study. Ferritin increased by 1043 (SD 1516) IU/L and 148 (SD 1319) IU/L in the liberal and restrictive arms, respectively. Selected QOL scores were superior pre-transfusion and more patients achieved clinically important improvements in the liberal arm compared with the restrictive arm for selected symptoms and function domains. CONCLUSION The results establish that policies for transfusion support can be delivered in practice at multiple hospitals, but further research is required to understand the full clinical effects and safety of liberal transfusion policies in MDS outpatients.
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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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Evaluation of advanced platelet-rich fibrin compared to subepithelial connective tissue graft in the surgical management of interdental papilla recession: a randomized controlled trial
Barakat, S. O., Tawfik, O. K., Kholy, S. E., ElNahass, H.
Clinical oral investigations. 2024;28(1):87
Abstract
OBJECTIVES The current study aims to compare advanced-platelet-rich fibrin membrane (A-PRF) to connective tissue graft (CTG) using Han and Takei's approach. MATERIALS AND METHODS The defective papilla was randomly allocated to either the control group (CTG) or to the experimental group (A-PRF). Papilla height (PH) and percent change in the gingival black triangle (GBT) area were recorded at 1, 3, 6, 9, and 12 months. RESULTS Thirty-two deficient IDPs with an initial papilla presence index (PPI) of 2 or 3 were included. At 12 months, the papilla-fill significantly increased in both groups (p < 0.001) without a significant difference between the study groups (p = 0.637). A mean gain in IDP height of 2.25 mm (± 0.97) in the CTG group and 1.86 mm (± 0.7) in the A-PRF group were recorded with a nonsignificant difference. Gingival black triangle fill showed a 57.98% fill in the CTG and 54.65% fill in the A-PRF group, with no statistically significant difference between the groups (0.956). Regarding postoperative pain patients, the CTG group consumed significantly more analgesics than the A-PRF group (11.75 ± 3.51 and 8 ± 3.08, respectively, with p = 0.003). CONCLUSION Both CTG and A-PRF were found to be equally effective in increasing deficient IDP height with Han and Takei's surgical technique, with no significant difference. Within the current study's limitations, A-PRF seems to be a viable alternative to CTG in the treatment of GBTs. CLINICAL RELEVANCE Multilayered A-PRF membrane can be used as a choice in the augmentation of receded papillae, using Han and Takei's technique.
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Outcomes of Patients Enrolled in a Prospective and Randomized Trial on Basis of Gestalt Assessment or ABC Score
Baird, E. W., Lammers, D. T., Abraham, P., Hashmi, Z. G., Griffin, R. L., Stephens, S. W., Jansen, J. O., Holcomb, J. B.
The journal of trauma and acute care surgery. 2024
Abstract
INTRODUCTION The Pragmatic Randomized Optimal Platelet and Plasma Ratios (PROPPR) trial rapidly enrolled patients based on an ABC ≥ 2 score, or Physician Gestalt (PG) when ABC score was <2. The objective of this study was to describe what patients were enrolled by the two methods and whether patient outcomes differed based these enrollments. We hypothesized that there would be no differences in outcomes based on whether patients were enrolled via ABC score or PG. METHODS Patients were enrolled with an ABC ≥ 2 or by PG when ABC was <2 by the attending trauma surgeon. We compared 1-, 3-, 6-, 12-, 18- and 24-hour mortality, 30-day mortality, time to hemostasis, emergent surgical or interventional radiology procedure and the proportion of patients who required either >10 units of blood in 24 hours or > 3 units in one hour. RESULTS Of 680 patients, 438 (64%) were enrolled on the basis of an ABC score ≥ 2 and 242 (36% by PG when the ABC score was <2. Patients enrolled by PG were older (median 44, IQR 28-59, p < 0.001), more likely to be white (70.3% vs 60.3%, p = 0.014), and more likely to have been injured by blunt mechanisms (77.3% vs 37.2%, p < 0.001). They were also less hypotensive and less tachycardic than patients enrolled by ABC score (both p < 0.001). The groups had similar Injury Severity Scores in the ABC ≥ 2 and PG groups (26 and 27 respectively) and were equally represented (49.1% and 50.8% respectively) in the 1:1:1 treatment arm. There were no significant differences between the ABC score and PG groups for mortality at any point. Time to hemostasis (108 for patients enrolled on basis of Gestalt, vs. 100 mins for patients enrolled on basis of ABC score), and the proportion of patients requiring a massive transfusion (>10 units/24 h) (44.2% vs. 47.3%), or meeting the critical administration threshold (>3 unit/1 hr) (84.7% vs. 89.5%) were similar (p = 0.071). CONCLUSION Early identification of trauma patients likely to require a massive transfusion is important for clinical care, resource use, and selection of patients for clinical trials. Patients enrolled in the PROPPR trial based on PG when the ABC score was <2 represented 36% of the patients and had identical outcomes to those enrolled on the basis of an ABC score of ≥2. LEVEL OF EVIDENCE Level III, Prognostic.
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The effects of injectable platelet-rich fibrin application on wound healing following gingivectomy and gingivoplasty operations: single-blind, randomized controlled, prospective clinical study
Bahar, ŞÇ, Karakan, N. C., Vurmaz, A.
Clinical oral investigations. 2024;28(1):85
Abstract
OBJECTIVES The aim of this study was to evaluate the effects of wound healing using injectable platelet-rich fibrin (IPRF) after gingivectomy and gingivoplasty. MATERIALS AND METHODS In this clinical study, 46 systemically healthy patients with chronic inflammatory gingival enlargement were randomly treated with gingivectomy-gingivoplasty + I-PRF (n=23) or gingivectomy-gingivoplasty alone (n=23). The primary outcome was to evaluate the effect of I-PRF on wound healing over a 3-week follow-up period. Samples collected from gingival crevicular fluid (GCF) were processed using enzyme-linked immunosorbent assay (ELİSA) to measure VEGF and FGF-10 biomarkers. The surgical areas were stained with Mira-2 tone and evaluated in ImageJ. Wound healing was evaluated with Modified Manchester Scar (MMS) scale and Landry, Turnbull, and Howley (LTH) index. RESULTS VEGF values of the control group at baseline, week 2, and week 3 were significantly higher than the test group. In weeks 2 and 3, FGF-10 values were found to be significantly higher in the control group than the test group. The amount of staining was found to be significantly higher in the control group than in the test group on days 3, 7, and 14. LTH values of the control group were significantly lower than the test group and MMS values were significantly higher than those of the test group. CONCLUSIONS I-PRF applications revealed positive effects on epithelial wound healing after gingivectomy and gingivoplasty operations. CLINICAL RELEVANCE Platelet concentrates such as I-PRF accelerate wound healing and contribute to the patient's comfort and quality of life. I-PRF application may have positive effects on wound healing after gingivectomy and gingivoplasty operations.
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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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Effectiveness of Advanced Platelet-Rich Fibrin on Postoperative Sequelae for Impacted Mandibular Third Molar Surgery: A Prospective Study
Mathialagan Kalai Selvam, L., M, A., Lakshmanan, S., Kumar, S. P.
Cureus. 2024;16(1):e52297
Abstract
Introduction Impacted third molar extraction is frequently removed surgically by maxillofacial surgeons, which is mostly associated with postoperative sequelae like pain and swelling. It is essential to minimize the complications and enhance wound healing in the extracted socket of the third molar. Hence, this study aimed to assess the efficiency of advanced platelet-rich fibrin (A-PRF) in wound healing and reducing pain after surgical extraction of the impacted mandibular third molar (IMTM). Materials and methods Thirty healthy patients who have been diagnosed with Pell and Gregory class II IMTM were included in this study. In the study group, which comprises 15 patients, extraction sockets were filled with A-PRF extract. In the control group, no material was placed in the extraction sockets. The pain was assessed preoperative and on the third and seventh postoperative days using a visual analog scale (VAS). Wound healing was assessed on the third and seventh postoperative days using a modified laundry scale. SPSS for Windows was used for data analysis. Categorical data was compared between the groups using the Chi-square test. P-value less than 0.05 was considered as statistically significant. Results The study population's mean age was 25.67 ± 2.4 years. Nineteen patients were male, and 11 patients were female. Differences in mean pain scores between the groups were not statistically significant both on the third postoperative day (p=0.59) and the seventh postoperative day (p=0.33). During the seventh day postoperative day, the study group exhibited better wound healing compared to the control group and the results were statistically significant (p=0.01). Conclusion A-PRF is a simple and effective method of reducing postoperative sequela by promoting wound healing after surgical extraction of IMTM. It has the advantage of less chance of allergic and anaphylactic reactions, unlike their predecessor platelet concentrates.