A S Ducloy-Bouthors1, A Duhamel2, E Kipnis1, A Tournoys3, A Prado-Dupont4, A Elkalioubie5, E Jeanpierre3, G Debize6, E Peynaud-Debayle7, D DeProst8, C Huissoud9, A Rauch3, S Susen10. 1. Pole d'Anesthésie-Réanimation, CHU Lille, France. 2. Pole de Santé Publique, CHU Lille, Lille, France EA2694, Université of Lille Nord de France, France. 3. Hématologie Transfusion, Pôle de Biologie Pathologie Génétique, CHU Lille, France Inserm U1011, Laboratoire de Recherche J&K, Institut Pasteur de Lille, Faculté de Médecine - Pôle recherche, University of Lille Nord de France, EGID, Lille, France. 4. Inserm U1011, Laboratoire de Recherche J&K, Institut Pasteur de Lille, Faculté de Médecine - Pôle recherche, University of Lille Nord de France, EGID, Lille, France Pole d'hématologie, Maternité Monaco, Centre hospitalier, Valenciennes, France. 5. Inserm U1011, Laboratoire de Recherche J&K, Institut Pasteur de Lille, Faculté de Médecine - Pôle recherche, University of Lille Nord de France, EGID, Lille, France. 6. Pole d'hématologie, Hôpital de la Croix Rousse, Hôpitaux civils Lyon, Lyon, France. 7. APHP, Hôpital Louis Mourier, Service d'Hématologie Biologique, F-92701 Colombes, France. 8. APHP, Hôpital Louis Mourier, Service d'Hématologie Biologique, F-92701 Colombes, France University Paris Diderot, Sorbonne Paris Cité, F-75018 Paris, France. 9. Pole d'obstétrique, Hôpital de la Croix Rousse, Hôpitaux Civils Lyon, Lyon, France. 10. Hématologie Transfusion, Pôle de Biologie Pathologie Génétique, CHU Lille, France Inserm U1011, Laboratoire de Recherche J&K, Institut Pasteur de Lille, Faculté de Médecine - Pôle recherche, University of Lille Nord de France, EGID, Lille, France sophie.susen@inserm.fr.
Abstract
BACKGROUND: Beneficial effects of tranexamic acid (TA) have been established in surgery and trauma. In ongoing postpartum haemorrhage (PPH), a moderate reduction of blood loss was observed in a previously published randomized controlled trial. Analysis of haemostasis parameters obtained from samples collected as part of this study are presented. METHODS:Women with PPH >800 ml after vaginal delivery were assigned to receive either TA (4 g over 1 h, then 1 g per h over six h) (TA) or not (H). A non-haemorrhagic group (NH), <800 ml blood loss, was included as postpartum reference. At four time-points (enrolment, +30 min, +2 h, +6 h), haemostasis was assessed. Haemostasis assays were performed blinded to group allocation. Data were expressed as median [interquartiles] and compared with non-parametric tests. RESULTS: In H compared with NH group, D-dimers increase (3730 ng ml(-1) [2468-8493] vs 2649 [2667-4375]; P=0.0001) and fibrinogen and factor II decrease were observed at enrolment and became maximal 2 h later. When comparing TA to H patients, the increase in Plasmin-Antiplasmin-complexes at +30 min (486 ng ml(-1) [340-1116] vs 674 [548-1640]; P=0.03) and D-dimers at +2 h (3888 ng ml(-1) [2688-6172] vs 7495 [4400-15772]; P=0.0001) was blunted. TA had no effect on fibrinogen decrease. CONCLUSIONS: This study provides biological evidence of an early increase in D-dimers and plasmin-antiplasmin complexes associated with active post-partum haemorrhage and its attenuation by the early use of a clinically effective high dose of TA, opening the perspective of dose ranging studies to determinate the optimal dose and timing in this setting. CLINICAL TRIAL REGISTRATION: ISRCTN09968140.
RCT Entities:
BACKGROUND: Beneficial effects of tranexamic acid (TA) have been established in surgery and trauma. In ongoing postpartum haemorrhage (PPH), a moderate reduction of blood loss was observed in a previously published randomized controlled trial. Analysis of haemostasis parameters obtained from samples collected as part of this study are presented. METHODS:Women with PPH >800 ml after vaginal delivery were assigned to receive either TA (4 g over 1 h, then 1 g per h over six h) (TA) or not (H). A non-haemorrhagic group (NH), <800 ml blood loss, was included as postpartum reference. At four time-points (enrolment, +30 min, +2 h, +6 h), haemostasis was assessed. Haemostasis assays were performed blinded to group allocation. Data were expressed as median [interquartiles] and compared with non-parametric tests. RESULTS: In H compared with NH group, D-dimers increase (3730 ng ml(-1) [2468-8493] vs 2649 [2667-4375]; P=0.0001) and fibrinogen and factor II decrease were observed at enrolment and became maximal 2 h later. When comparing TA to H patients, the increase in Plasmin-Antiplasmin-complexes at +30 min (486 ng ml(-1) [340-1116] vs 674 [548-1640]; P=0.03) and D-dimers at +2 h (3888 ng ml(-1) [2688-6172] vs 7495 [4400-15772]; P=0.0001) was blunted. TA had no effect on fibrinogen decrease. CONCLUSIONS: This study provides biological evidence of an early increase in D-dimers and plasmin-antiplasmin complexes associated with active post-partum haemorrhage and its attenuation by the early use of a clinically effective high dose of TA, opening the perspective of dose ranging studies to determinate the optimal dose and timing in this setting. CLINICAL TRIAL REGISTRATION: ISRCTN09968140.
Authors: Homa K Ahmadzia; Naomi L C Luban; Shuhui Li; Dong Guo; Adam Miszta; Jogarao V S Gobburu; Jeffrey S Berger; Andra H James; Alisa S Wolberg; John van den Anker Journal: Am J Obstet Gynecol Date: 2020-11-26 Impact factor: 10.693