TATRA

The goal of this clinical trial is to learn if the administration of tranexamic acid canreduce the necessity of blood transfusions in adult patients undergoing major abdominalsurgery. It will also inform about safety of tranexamic acid in this setting.The main question it aims to answer is: Does tranexamic acid lower the probability ofreceiving at least one blood transfusion during or after surgery?Participants will compare tranexamic acid o a placebo (a look-alike substance thatcontains no drug) to see if tranexamic acid works to reduce the necessity of a bloodtransfusion.

{ "short_title": "TATRA", "data_mode": "900", "data_mode_number": "000002381", "official_title": "Tranexamic Acid for Reduction of Intra- and Postoperative Transfusion Requirements in Elective Abdominal Surgery: Randomized Controlled Trial", "accrual_state": "running", "therapeutic_value": "therapeutic", "therapieansatz_value": "not_applicable", "therapieintervention_value": "not_applicable", "therapielinie_value": "not_applicable", "ctgov_number": "NCT06414031", "eudract_number": "2023-509970-43", "general_contact_email": "studienzentrum-vtg@ukdd.de", "general_contact_phone": null, "hauptpruefer_dd_name": "Dr. med. Olga Radulova-Mauersberge", "description_laie_de": "Ziel dieser Studie ist es, herauszufinden, ob die Verabreichung von Tranexams\u00e4ure die Notwendigkeit von Bluttransfusionen bei erwachsenen Patienten, die sich einer gr\u00f6\u00dferen abdominalen Operation unterziehen, verringern kann. Au\u00dferdem soll die Studie Aufschluss \u00fcber die Sicherheit von Tranexams\u00e4ure in diesem Zusammenhang geben, wobei die Hauptfrage lautet: Verringert Tranexams\u00e4ure die Wahrscheinlichkeit, w\u00e4hrend oder nach einer Operation mindestens eine Bluttransfusion zu erhalten? Die Teilnehmer erhalten verblindet Tranexams\u00e4ure oder ein Placebo (einer wirkstoff\u00e4hnlichen Substanz, die kein Medikament enth\u00e4lt).", "description_laie_en": null, "description_expert_de": null, "description_expert_en": "The goal of this clinical trial is to learn if the administration of tranexamic acid canreduce the necessity of blood transfusions in adult patients undergoing major abdominalsurgery. It will also inform about safety of tranexamic acid in this setting.The main question it aims to answer is: Does tranexamic acid lower the probability ofreceiving at least one blood transfusion during or after surgery?Participants will compare tranexamic acid o a placebo (a look-alike substance thatcontains no drug) to see if tranexamic acid works to reduce the necessity of a bloodtransfusion.", "rechtsgrundlage_value": "AMG", "phase_amg_value": "III", "main_cat_id": 2, "sub_cat_id": 6 }