02.04. Área de Salud IV Noroeste

Efficacy and safety of recombinant activated factor VII for secondary prophylaxis in patients with Glanzmann thrombasthenia

2026-09-18T05:51:08Z

Efficacy and safety of recombinant activated factor VII for secondary prophylaxis in patients with Glanzmann thrombasthenia García-Jaen, Pablo; Ferandez-Mosteirin, Nuria; Serrano, María-Luisa; Riesco, Susana; Aguilar, Carlos; Gabaldon, David; Kanaan-Leis, Sara; González-Prieto, Almudena; Portugal, Raquel; Mendoza, María-del-Carmen; Gilabert, Carmen; Hortal, Ana; Díaz-Ajenjo, Lorena; Lama-Villanueva, Ana; González-Galan, Alba-Mei; Sánchez-Fuentes, Ana; Benito, Rocío; Rivera, José; González-Porras, José-Ramon; Bastida, José-María BACKGROUND: Glanzmann thrombasthenia (GT) is a rare inherited platelet disorder associated with recurrent and sometimes life-threatening bleeding. Recombinant activated factor VII (rFVIIa) is approved for treatment of bleeding episodes or surgical prophylaxis in patients with GT who are refractory or alloimmunized to platelet transfusions. However, evidence for its use as secondary prophylaxis remains scarce. OBJECTIVES: This study described the efficacy and safety of rFVIIa secondary prophylaxis in patients with GT and recurrent and uncontrolled bleeding despite standard therapy. METHODS: A multicenter, retrospective study of patients with GT included in the Spanish Registry of Patients with Inherited Platelet Disorders (RETPLAC) was performed. We evaluated bleeding severity using the International Society on Thrombosis and Haemostasis (ISTH) bleeding assessment tool (BAT) and calculated the annualized bleeding rate (ABR) before and during rFVIIa prophylaxis. RESULTS: Of the 37 patients with GT included in RETPLAC, 4 patients received regular rFVIIa prophylaxis due to recurrent severe bleeding. Median baseline ISTH-BAT score was 13.5 (IQR, 9.5-18), and median preprophylaxis ABR was 3 (IQR, 3-5.25). All patients received rFVIIa of 90 ?g/kg, 3 twice weekly and 1 monthly. The median prophylaxis duration was 7.5 months (IQR, 6.75-12). Prophylaxis led to a 57.1% overall reduction in ABR, with resolution of severe bleeding in 2 patients and reduction in frequency in the remaining 2. Three patients achieved transfusion independence. All patients showed improvement in hemoglobin and iron profile. No thrombotic or adverse events occurred. CONCLUSION: Secondary prophylaxis with rFVIIa may be an effective option in patients with GT and recurrent severe bleeding unresponsive to standard therapy. Prospective studies are necessary to optimize dosing schedules and define its role in secondary prophylaxis.

Dosing Strategies for High-Alert Medications in Obese Pediatric Patients: A Systematic Review

2026-09-18T05:52:37Z

Dosing Strategies for High-Alert Medications in Obese Pediatric Patients: A Systematic Review Hernández-Gago, Yolanda; Alcala-Minagorre, Pedro-J; Sánchez-Hernández, José-German; Rodríguez-Marrodan, Belén; Hernández-Sabater, Laura; Rodríguez-Negrín, Ana-Cristina; Rodríguez-Suárez, Claudio-Alberto Background/Objective: Childhood obesity induces physiological changes that alter drug distribution and clearance; however, these patients are often excluded from clinical trials, creating a critical safety gap for high-alert medications (HAM). The Objective was to evaluate HAM dosing strategies and pharmacokinetic (PK) alterations in overweight and obese pediatric patients. Methods: A systematic review was conducted and registered in PROSPERO (CRD42023452126). A search of MEDLINE, EMBASE, Web of Science, and Cochrane CENTRAL (1990-March 2026) identified studies reporting dosing strategies or PK of HAM in obese or overweight pediatric patients. Studies were included if they reported dosing recommendations or PK parameters. Eligible designs comprised prospective and retrospective, randomized and non-randomized, observational (cohort, case-control, and cross-sectional), case series, case reports, and narrative and systematic reviews. Study selection, data extraction, and quality assessment were conducted independently by two reviewers. Methodological quality was assessed using validated tools, and results were synthesized qualitatively. Results: Of 5801 records, 91 studies were included, providing evidence for only 27% of the evaluated HAM. Total body weight (TBW) appeared to be appropriate for insulin and vancomycin, although close monitoring was required. TBW-based dosing was associated with approximately 20% overexposure for enoxaparin, supporting the use of fat-free mass (FFM) or reduced dosing strategies. Increased clearance may justify higher doses for amlodipine and consideration of adult-equivalent dosing for metformin in adolescents. For gentamicin, FFM appeared to be the most appropriate descriptor, while adjusted body weight was used for valproic acid. In anesthetics and sedatives, reduced TBW-based dosing may be considered for propofol, whereas ideal body weight (IBW) or FFM were generally preferred for ketamine and dexmedetomidine. Analgesics such as fentanyl and morphine may require IBW- or FFM-based dosing, and maintenance dosing of paracetamol may require adjustment. Conclusions: Evidence remains limited and heterogeneous, with no standardized dosing approach. Model-informed strategies-such as population PK (PopPK) and physiologically based PK model (PBPK) approaches-may be useful for hypothesis generation and exploring PK variability; however, their clinical applicability is constrained by the limited and heterogeneous evidence base, and they should be considered exploratory.

The use of immersive technologies in learning about postpartum hemorrhage: Protocol for a systematic review and meta-analysis

2026-08-03T10:48:57Z

The use of immersive technologies in learning about postpartum hemorrhage: Protocol for a systematic review and meta-analysis Montiel-Bravo, María-José; Ferrandini-Price, Mariana; Pardo-Ríos, Manuel; Sánchez-Gómez, Marina; Piuvezam, Grasiela; Silva-de-Medeiros, Gidyenne-Christine-Bandeira; López-López, Carmen-Amalia Postpartum hemorrhage is one of the leading causes of maternal morbidity and mortality worldwide, and its proper management requires both technical and non-technical skills. This study describes the protocol for a systematic review evaluating the effectiveness of immersive technologies in training healthcare professionals in the management of this obstetric emergency. This protocol was registered in the International Prospective Register of Systematic Reviews (PROSPERO) database (CRD420250614446). The search will be performed in the following databases: PubMed, Embase, Scopus, ScienceDirect, Web of Science, Cochrane Library, LILACS, Enfispo and CUIDEN. Intervention studies (clinical trials - randomized or non-randomized) and quasi-experimental studies will be included. The risk of bias will be assessed using appropriate tools according to study design: the Risk of Bias 2 (ROB 2) tool for randomized controlled trials and the Risk Of Bias In Non-randomized Studies of Interventions (ROBINS-I) tool for non-randomized and quasi-experimental studies. Two independent researchers will conduct all assessments, and any disagreements will be consulted with a third reviewer. The data analysis and synthesis will be performed using Review Manager software version 5.4. We will conduct the study in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P) guidelines. The review will summarize the current evidence on the use of virtual reality, augmented reality, and mixed reality in education and training for postpartum hemorrhage management. The planned systematic review will identify and synthesize the available evidence on how immersive technologies may improve learning about postpartum hemorrhage.

Nationwide Implementation of Double Reflex Testing for Hepatitis Delta in Spain: Results From the Retrospective Phase of the Spain-DDR Study

2026-05-13T11:02:52Z

Nationwide Implementation of Double Reflex Testing for Hepatitis Delta in Spain: Results From the Retrospective Phase of the Spain-DDR Study Alberola, Ana; De-Salazar, Adolfo; Fuentes, Ana; Carracedo, Raquel; Illescas-lopez, Marta; Rodríguez-Baños, María-del-Carmen; Freyre, Carolina; Becerril, Berta; Viciana, Isabel; López-rodriguez, Inmaculada; Montiel, Natalia; Domínguez-Castaño, Ana-María; Luzón-García, María-Pilar; Ramírez-Arellano, Encarnación; Liébana-martos, Carmen; Franco-Álvarez-de-Luna, Francisco; Lozano, María-del-Carmen; Palop, Begona; Sampedro, Antonio; Pérez, Ana-Belén; Algarate, Sonia; Rojo-Alba, Susana; Fraile, Pablo; Ocete, Dolores; Alcaraz, María-Jesús; Rodríguez, Juan-Carlos; Hernández-Felices, Francisco-Javier; Martínez, Olalla; Domínguez, Victoria; Orta, Nieves; Gómez, Dolores; Cortell, Carmen; Camacho, Jorge; Sabater, Susana; Iglesias-Sánchez, Luis-Ángel; Martin, Yasmina; Vallejo, Aldara; Molina, Lourdes; Aroca, María; Castro, Beatriz; Lara, Magdalena; Pena, María-José; Rodríguez-fernández, Ana; González-Praetorius, Alejandro; Blas, José-Joaquín; Beteta, Alicia; Gómez, Cesar; Rodríguez, María-José; Illescas, Soledad; Abreu, Melanie; García-Díez, Julio; Beltran, Inocencio; Sandoval-Torrientes, Marta; Sáez, Ruth; Martín, Teresa; Tajada-Alegre, Pilar; Lorenzo, Belén; García-Valero, María-Teresa; Jiménez-Sansegundo, Isabel; García-de-Cruz, Susana; Garcinuno, Sonsoles; Saiz, Miguel-Ángel; Muñoz, Santiago; Fernández, Isabel; Lorenzo-Juanes, Helena-Miriam; Vidal-Acuña, María-Reyes; Moldes, Luz-María; Calvo, Noelia; Trigo, Matilde; Gude, María-José; Ordonez, Patricia; Cortizo, Sandra; Blasco, Miriam; Sigcha, Mayra; Falcés, Iker; Galan, Juan-Carlos; Arribi, Ana; Alonso, Roberto; Iborra-Bendicho, María-Asunción; del-Amor-Espín, María-Jesús; Cascales-Alcolea, Eva; Pérez-Pardo, Cayetano; Fernández, Pablo; Navarro-Martínez, María-Dolores; Núñez-Trigueros, María-Luz; Galán-Ros, Jorge; Gil-gallardo, Luis-Javier; Miqueleiz, Ana; Reina, Gabriel; Elorduy, Luis; Macho, Mikele; Gómez, Carmen; Liendo, Paloma; Salicio, Yolanda; Aguilera, Antonio; García, Federico BACKGROUND: Hepatitis delta virus accelerates liver disease progression in chronic hepatitis B, yet remains underdiagnosed. Guidelines recommend double reflex diagnostic testing with antibody testing followed by viral load testing, but uptake remains inconsistent. AIMS: To evaluate double reflex diagnostic implementation in Spain during the retrospective phase of the Spain Double Reflex Diagnostic study. METHODS: Nationwide, multicenter retrospective analysis of individuals positive for hepatitis B surface antigen (2022-2024) from 80 centers. Laboratory data included hepatitis B surface antigen, hepatitis delta virus antibody and hepatitis delta virus viral load. Uptake rates, hepatitis delta virus antibody positivity, viral load confirmation and viral load-confirmed prevalence were calculated with 95% confidence intervals. RESULTS: Among 65,763 individuals positive for hepatitis B surface antigen, hepatitis delta virus antibody testing uptake increased from 55.1% (54.4-55.8) in 2022 (n = 18,986) to 72.5% (71.9-73.1) in 2023 (n = 22,463) and 85.8% (85.1-86.4) in 2024 (n = 24,314; p < 0.0001). Antibody positivity remained stable (5.6%, 4.9%, 5.3%). Viral load confirmation among antibody-positive patients improved from 72.6% in 2022 to 90.8% in 2023 and 91.0% in 2024. Viral load-confirmed prevalence among antibody-positive individuals was 40.3% in 2022, 31.6% in 2023, and 30.1% in 2024. Regional heterogeneity was marked, with several autonomous communities achieving near-universal uptake (> 95%). CONCLUSION: Between 2022 and 2024, double reflex diagnostic implementation expanded rapidly, demonstrating national feasibility and describing hepatitis D virus seroprevalence. However, regional inequities persist. Sustained uptake will require standardised reflex protocols, harmonization of viral load assays and continuous training to reduce underdiagnosis and improve care of coinfected patients.