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Alternative routes for tranexamic acid treatment in obstetric bleeding (WOMAN-PharmacoTXA trial): a randomised trial and pharmacological study in caesarean section births.
Shakur-Still, Haleema; Roberts, Ian; Grassin-Delyle, Stanislas; Chaudhri, Rizwana; Geer, Amber; Arribas, Monica; Lamy, Elodie; Mansukhani, Raoul; Lubeya, Mwansa Ketty; Javaid, Kiran; Kayani, Aasia; Israr, Naila; Mazhar, Syeda Batool; Urien, Saïk; Bouazza, Naïm; Foissac, Frantz; Prowse, Danielle; Carrington, Laura; Barrow, Collette; Onandia, Julio Gil; Balogun, Eni.
Afiliación
  • Shakur-Still H; Clinical Trials Unit - Global Health Clinical Trials Group, London School of Hygiene & Tropical Medicine, London, UK.
  • Roberts I; Clinical Trials Unit - Global Health Clinical Trials Group, London School of Hygiene & Tropical Medicine, London, UK.
  • Grassin-Delyle S; Département des Maladies des Voies Respiratoires, Hôpital Foch, Suresnes, France.
  • Chaudhri R; Infection et Inflammation, Département de Biotechnologie de la Santé, Université Paris-Saclay, UVSQ, INSERM, Montigny le Bretonneux, France.
  • Geer A; Global Institute of Human Development, Shifa Tameer-e-Millat University, Islamabad, Pakistan.
  • Arribas M; Clinical Trials Unit - Global Health Clinical Trials Group, London School of Hygiene & Tropical Medicine, London, UK.
  • Lamy E; Clinical Trials Unit - Global Health Clinical Trials Group, London School of Hygiene & Tropical Medicine, London, UK.
  • Mansukhani R; Infection et Inflammation, Département de Biotechnologie de la Santé, Université Paris-Saclay, UVSQ, INSERM, Montigny le Bretonneux, France.
  • Lubeya MK; Clinical Trials Unit - Global Health Clinical Trials Group, London School of Hygiene & Tropical Medicine, London, UK.
  • Javaid K; Women and Newborn Hospital, University Teaching Hospital, Lusaka, Zambia.
  • Kayani A; Department of Obstetrics and Gynaecology, The University of Zambia School of Medicine, Lusaka, Zambia.
  • Israr N; Global Institute of Human Development, Shifa Tameer-e-Millat University, Islamabad, Pakistan.
  • Mazhar SB; Global Institute of Human Development, Shifa Tameer-e-Millat University, Islamabad, Pakistan.
  • Urien S; Department of Obstetrics and Gynaecology, Federal Government Polyclinic Hospital, Islamabad, Pakistan.
  • Bouazza N; Mother and Child Health Centre, Pakistan Institute of Medical Sciences, Shaheed Zulfikar Ali Bhutto Medical University, Islamabad, Pakistan.
  • Foissac F; Paediatric and Perinatal Drug Evaluation and Pharmacology, Université Paris Cité, Paris, France.
  • Prowse D; Paediatric and Perinatal Drug Evaluation and Pharmacology, Université Paris Cité, Paris, France.
  • Carrington L; Paediatric and Perinatal Drug Evaluation and Pharmacology, Université Paris Cité, Paris, France.
  • Barrow C; Clinical Trials Unit - Global Health Clinical Trials Group, London School of Hygiene & Tropical Medicine, London, UK.
  • Onandia JG; Clinical Trials Unit - Global Health Clinical Trials Group, London School of Hygiene & Tropical Medicine, London, UK.
  • Balogun E; Clinical Trials Unit - Global Health Clinical Trials Group, London School of Hygiene & Tropical Medicine, London, UK.
BJOG ; 130(10): 1177-1186, 2023 09.
Article en En | MEDLINE | ID: mdl-37019443
OBJECTIVE: To examine the safety, efficacy and pharmacology of intravenous (IV), intramuscular (IM) and oral tranexamic acid (TXA) use in pregnant women. DESIGN: Randomised, open-label trial. SETTING: Hospitals in Pakistan and Zambia. POPULATION: Women giving birth by caesarean section. METHODS: Women were randomised to receive 1 g IV, 1 g IM, 4 g oral TXA or no TXA. Adverse events in women and neonates were recorded. TXA concentration in whole blood was measured and the concentrations over time were examined with population pharmacokinetics. The relationship between drug exposure and D-dimer was explored. The trial registration is NCT04274335. MAIN OUTCOME MEASURES: Concentration of TXA in maternal blood. RESULTS: Of the 120 women included in the randomised safety study, there were no serious maternal or neonatal adverse events. TXA concentrations in 755 maternal blood and 87 cord blood samples were described by a two-compartment model with one effect compartment linked by rate transfer constants. Maximum maternal concentrations were 46.9, 21.6 and 18.1 mg/L for IV, IM and oral administration, respectively, and 9.5, 7.9 and 9.1 mg/L in the neonates. The TXA response was modelled as an inhibitory effect on the D-dimer production rate. The half-maximal inhibitory concentration (IC50 ) was 7.5 mg/L and was achieved after 2.6, 6.4 and 47 minutes with IV, IM and oral administration of TXA, respectively. CONCLUSIONS: Both IM and oral TXA are well tolerated. Oral TXA took about 1 hour to reach minimum therapeutic concentrations and would not be suitable for emergency treatment. Intramuscular TXA inhibits fibrinolysis within 10 minutes and may be a suitable alternative to IV.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Ácido Tranexámico / Antifibrinolíticos Tipo de estudio: Clinical_trials Límite: Female / Humans / Newborn / Pregnancy Idioma: En Revista: BJOG Asunto de la revista: GINECOLOGIA / OBSTETRICIA Año: 2023 Tipo del documento: Article Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Ácido Tranexámico / Antifibrinolíticos Tipo de estudio: Clinical_trials Límite: Female / Humans / Newborn / Pregnancy Idioma: En Revista: BJOG Asunto de la revista: GINECOLOGIA / OBSTETRICIA Año: 2023 Tipo del documento: Article Pais de publicación: Reino Unido