Table of contents
Trial overview
The source data include one interventional study that listed Aminocaproic Acid among the drugs used in the trial record.[1] The study was designed to learn whether the treatment approach could help with bleeding control in people who needed urgent surgery or a procedure and had a major risk of bleeding.[1]
The trial title says it studied whether andexanet alfa is safe and works to limit bleeding in people who take factor 10a inhibitors and urgently need surgery.[1] The brief summary says the goal was to assess whether andexanet could achieve effective intraoperative hemostasis compared with usual care.[1]
Who was studied
The trial focused on people taking a factor Xa inhibitor, which is a type of blood thinner.[1] The specific medicines named in the source were apixaban, rivaroxaban, and edoxaban.[1]
These participants needed urgent surgery or another procedure and had a major risk of bleeding.[1] This means the study population was made up of patients in a high-risk situation where bleeding control was especially important.[1]
What was measured
The main endpoint was effective intraoperative hemostasis.[1] Hemostasis means stopping bleeding, and intraoperative means during surgery.[1]
The brief summary also shows that the study aimed to compare the treatment approach with usual care.[1] In simple terms, the researchers wanted to see whether the study treatment worked better than standard treatment used in everyday care.[1]
Trial phase and status
The study was a Phase 3 trial.[1] Phase 3 trials usually involve many people and are used to test how well a treatment works in a larger group.[1]
The trial status was completed, and the enrollment was 1,021 participants.[1] This shows that the study was finished and included a large number of patients.[1]
Key patient terms
Urgent surgery means surgery that cannot wait for a long time.[1] A procedure is another medical treatment or test that may require careful bleeding control.[1]
Major risk of bleeding means the chance of heavy bleeding is high, so the medical team needs to watch closely.[1] Usual care means the standard treatment or routine approach used outside the study.[1]
