Table of contents
- Trial overview
- Bleeding control and anticoagulation reversal
- Clot prevention after surgery
- Study after Roux-en-Y gastric bypass
- Main outcomes measured
- Who these trials are for
- Study phases and status
Trial overview
The provided trial data include four interventional Phase 3 studies that involve products linked to Human Coagulation Factor Vii in different clinical settings.[1][2][3][4] These studies are not all for the same condition, but they share a common goal: to see how well the studied treatment works in real patient situations.[1][2][3][4]
The trials cover emergency bleeding care, reversal of blood-thinner effect, prevention of blood clots after major orthopedic surgery, and changes in drug handling after gastric bypass surgery.[1][2][3][4] One study is marked Completed, while the others are Authorised.[1][2][3][4]
Bleeding control and anticoagulation reversal
NCT04867837 studied patients with acute major bleeding who were receiving direct oral anticoagulant (DOAC) therapy with a factor Xa inhibitor.[1] The study compared OCTAPLEX dosing strategies and aimed to show better hemostatic effectiveness, which means better control of bleeding.[1]
The main outcome in this trial was the proportion of patients in whom OCTAPLEX was rated as effective, based on an “excellent” or “good” result versus a “poor” or “none” result in the management of major bleeding events.[1] This makes the study focused on a practical question: how many patients achieve good bleeding control in an emergency setting.[1]
Another Phase 3 study, 2022-503012-16-00, looked at patients taking a factor Xa inhibitor who needed an urgent intervention with a high risk of bleeding.[2] It compared TAK-330 with standard of care 4F-PCC, which is a four-factor prothrombin complex concentrate used here as the usual treatment approach in the study.[2]
The main outcome in that trial was intraoperative effective hemostasis, meaning how well bleeding was controlled during surgery or another invasive procedure.[2] The assessment was made at the end of the procedure by the investigator, surgeon, or another qualified team member using a four-point scale.[2]
Clot prevention after surgery
NCT06581965 studied thrombosis prophylaxis, which means treatment to prevent blood clots, in patients undergoing total hip or total knee replacement.[3] The trial had a very large enrollment target and used a national, multicenter, randomized, multi-arm, open-label design.[3]
This study included different patient groups based on venous thromboembolism risk: low risk, intermediate risk, and high risk.[3] The brief summary says the study aimed to test whether in-hospital prophylaxis only is enough in low-risk patients, to measure the rate of symptomatic VTE in intermediate-risk patients, and to see whether intensified prophylaxis is more effective and equally safe in high-risk patients.[3]
The main outcomes were the number of VTEs and the number of major bleeds in the first 3 months after surgery.[3] This means the study looked at both clot prevention and bleeding safety, which are both important after major joint replacement.[3]
Study after Roux-en-Y gastric bypass
2024-519737-30-00 is a prospective study in patients after Roux-en-Y gastric bypass.[4] The brief summary says the goal is to assess the difference in the pharmacokinetics of apixaban before and after surgery.[4]
In simple terms, pharmacokinetics means how the body absorbs and handles a medicine over time.[4] The main outcome is the area under the curve (AUC) of anti-Xa levels at several time points, including before surgery and after surgery up to 60 days and around 3 months.[4]
This study is small compared with the others, with an enrollment of 30 participants, and it is also a Phase 3 interventional trial.[4] It focuses on whether surgery changes drug exposure, which may matter for patients who need anticoagulation after gastric bypass.[4]
Main outcomes measured
The trials use different primary outcomes, depending on the clinical question being studied.[1][2][3][4] In the bleeding studies, the main outcomes are hemostatic effectiveness and intraoperative hemostasis.[1][2]
In the joint replacement study, the outcomes are the number of venous thromboembolisms and the number of major bleeds during the first 3 months after surgery.[3] In the gastric bypass study, the main outcome is the AUC of anti-Xa levels across several time points.[4]
These outcomes are patient-centered because they measure real events, such as bleeding, clots, or drug levels, rather than only laboratory results.[1][2][3][4]
Who these trials are for
The target populations are different across the studies, but all are based on specific clinical needs.[1][2][3][4] Some trials include patients with life-threatening or major bleeding while on factor Xa inhibitor treatment.[1][2]
Other trials include people having hip or knee replacement surgery, where the study asks how best to prevent clots after the operation.[3] The last study includes patients after Roux-en-Y gastric bypass, where the researchers want to understand how surgery changes apixaban levels in the body.[4]
Study phases and status
All four studies are listed as Phase 3, which is an advanced stage of clinical research with larger patient groups.[1][2][3][4] One study, NCT04867837, is completed, while the others are authorised.[1][2][3][4]
The authorised studies are still part of the research pipeline, meaning they have been approved and are ready to move forward or continue according to the trial record.[2][3][4] The completed study already finished collecting its planned results.[1]
