Table of contents
- Trial overview
- Who is being studied
- What is being measured
- Trial phase and design
- Safety focus
- Trial status and size
Trial overview
The available study is an interventional clinical trial, which means researchers give a treatment and then observe what happens.[1] It is studying UNFRACTIONATED HEPARIN, PORCINE, CONJUGATED WITH HUMAN SERUM ALBUMIN in the setting of antithrombotic treatment for limb-threatening poor blood flow.[1]
The trial title describes an APAC antiplatelet and anticoagulant treatment study for limb-threatening impairment of blood flow, also called the HEALING-study.[1]
Who is being studied
The target population includes people with peripheral arterial occlusive disease (PAOD) and chronic limb-threatening ischemia (CLTI).[1] These conditions involve reduced blood flow to the limbs, and CLTI is the more severe form that can threaten the limb.[1]
The study also includes patients undergoing endovascular revascularization, which is a procedure done inside the blood vessels to improve blood flow.[1] This tells us the trial is focused on people who need a vascular procedure and are at risk from poor circulation.[1]
What is being measured
The main outcome is the occurrence and severity of treatment-emergent adverse events (TEAEs), meaning medical problems that start or worsen after treatment begins.[1] These events are measured from baseline to day 29 in Part A1 and to day 90 in Part A2 after the first dose of APAC.[1]
In Part B, TEAEs are also measured from baseline to day 90 after the first dose of APAC.[1] The study also tracks physical examination findings, vital signs, clinical laboratory data, and bleeding events using the ISTH bleeding score.[1]
For Part B, the researchers also record surgical adverse events, and they classify them using the Clavien-Dindo classification, which is a standard way to grade how serious surgical complications are.[1]
Trial phase and design
This is a Phase 2 study.[1] Phase 2 trials usually help researchers learn more about safety and tolerability in a defined patient group.[1]
The brief summary shows two parts of the study.[1] Part A evaluates the safety and tolerability of intravenous APAC as a single infusion and as weekly dosing, while Part B looks at the safety of selected doses and dosing frequency given around the procedure and weekly by intravenous route.[1]
Safety focus
The study is centered on safety and tolerability rather than on proving long-term benefit.[1] Researchers are paying close attention to bleeding, laboratory results, vital signs, and physical examination findings because these are important ways to monitor whether the treatment is being tolerated.[1]
Bleeding is especially important in this type of study because the treatment is being used in patients with serious blood flow problems who are also having a vascular procedure.[1]
Trial status and size
The trial status is Authorised, which means it has official approval to proceed.[1] The planned enrollment is 42 participants, so the study is relatively small and focused.[1]
Because the study is small and in Phase 2, its main goal is to build early information about safety in the specific patient group being treated.[1]
