Table of Contents
- Clinical trial overview
- Acute venous thromboembolism and antiplatelet use
- Transplant and ECMO studies
- Procedure-related anticoagulation studies
- Vascular disease, pain, and stem cell collection
- Healthy volunteer studies
- Phases, outcomes, and who can join
Clinical trial overview
The clinical trials in this set study Heparin Sodium in many different medical settings, not as one single disease treatment.[1] The studies are mainly looking at safety, bleeding, clot prevention, and how well treatment works during procedures or intensive care.[1][2]
Most of the trials are in Phase 2 or Phase 3, which means they are testing treatment strategies in patients and comparing outcomes across groups.[1][2] Two studies are Phase 1 bioequivalence studies in healthy adults, where the main goal is to compare how products behave in the body under study conditions.[8][9]
Acute venous thromboembolism and antiplatelet use
NCT05627375, also called the BAT-VTE study, looks at patients with an acute venous thromboembolism event who are already taking antiplatelet treatment for secondary arterial prevention at the time the clot is found.[1] The study compares full-dose anticoagulant therapy alone with full-dose anticoagulant therapy plus antiplatelet treatment.[1]
The main endpoint is clinically relevant bleeding, which includes major bleeding and clinically relevant non-major bleeding, measured by the end of the full-dose treatment period or up to 12 months.[1] This trial is authorised and plans to enroll 1,400 people, so it is a large study focused on bleeding risk in real patients with clot disease.[1]
Transplant and ECMO studies
The completed lung transplantation study, 2024-519503-10-00, tested whether heparin free VA-ECMO support could be used during clinical lung transplantation and how this might affect outcomes and inflammation.[2] Its main outcomes were arterial or venous thromboembolic events and circuit-related thrombosis, meaning clotting in the machine circuit.[2]
The CASUAL ECMO study, NCT06442267, is a Phase 3 trial in people with respiratory insufficiency, respiratory failure, circulatory failure, or acute respiratory distress syndrome.[4] It compares anticoagulation strategies using unfractionated heparin, low-molecular-weight heparin, and argatroban, and the main outcome is the incidence of thromboembolic events during ECMO therapy.[4]
Procedure-related anticoagulation studies
NCT05305612, the STOP CLOT Trial, studies patients undergoing transseptal procedures such as TEER and LAAC surgery.[3] The trial is looking at the best timing for starting anticoagulation during these procedures and compares physiological saline with HEPARINUM WZF.[3]
The primary efficacy endpoint is a combined measure that includes major adverse cardiac and cerebrovascular events, new thrombus formation seen during the procedure, or new ischemic brain lesions on MRI after the procedure.[3] This makes the trial important for understanding both heart and brain safety after the procedure.[3]
Vascular disease, pain, and stem cell collection
The HEALING study, 2025-522390-11-00, is a Phase 2 trial in people with peripheral arterial occlusive disease and chronic limb-threatening ischemia.[5] It evaluates the safety and tolerability of APAC dosing, with Heparin LEO used as part of the study treatment plan.[5] Safety measures include treatment-emergent adverse events, physical exams, vital signs, lab data, bleeding events, and surgical adverse events.[5]
NCT06497140 is a Phase 3 trial in symptomatic knee osteoarthritis that compares a genicular artery embolization procedure with a sham procedure, and Heparine Choay is one of the listed study drugs.[6] The main outcome is the change in Visual Analogue Scale pain score from randomization to 3 months, using a 0 to 100 mm scale where higher scores mean worse pain.[6]
The HEMO trial, 2023-509534-18-01, is a Phase 2 study in patients with lymphoma or myeloma who are having peripheral hematopoietic cell collection.[7] It tests whether a single bolus of heparin before stem cell collection can improve the collection yield, which is the number of stem cells collected after the first day.[7]
Healthy volunteer studies
Two Phase 1 studies include healthy adult volunteers rather than patients with a disease.[8][9] In these studies, Heparin Léčiva Injekční roztok is listed as part of the study interventions, but the main purpose is to test pharmacokinetic or bioequivalence outcomes for other medicines.[8][9]
One study looks at celecoxib oral suspension versus Celebrex under fasting and fed conditions, while the other compares amoxicillin/clavulanic acid with Augmentin ES under fed conditions.[8][9] Their main endpoints are AUC and Cmax, which are measures of how much drug enters the blood and how high the blood level gets.[8][9]
Phases, outcomes, and who can join
Across the trial set, the main outcomes focus on bleeding, clotting, procedure safety, and treatment success in the target condition.[1][2][3][4][5][6][7]
People who may join these studies depend on the trial and include adults with acute blood clots, transplant patients, ECMO patients, people undergoing heart or vessel procedures, patients with limb-threatening circulation problems, people with knee osteoarthritis, and patients with lymphoma or myeloma.[1][2][3][4][5][6][7]
The studies also use different ways to measure results, such as imaging tests, MRI, ultrasound, bleeding scores, lab tests, pain scales, and collection yield after stem cell harvest.[1][3][4][5][6][7]
