In short
Clinical trials are investigating Heparin Sodium in different patient groups, including people with acute blood clots, lung transplantation, ECMO support, knee osteoarthritis procedures, peripheral artery disease, and stem cell collection. These studies look at safety, bleeding, clot prevention, and how well treatment works in specific clinical settings.
Key points
- Clinical trials of Heparin Sodium are being done in several different patient groups, including people with acute venous thromboembolism, lung transplantation, ECMO support, heart procedures, knee osteoarthritis, peripheral artery disease, and stem cell collection. Most studies are Phase 2 or Phase 3, with a smaller number of Phase 1 studies in healthy volunteers. The main goals are to compare safety, bleeding risk, clot prevention, and procedure-related outcomes. Some trials also measure pain, surgical events, or the success of stem cell collection. The studies use Heparin Sodium in specific clinical settings rather than as a general treatment for all patients.
Clinical trial overview
The clinical trials in this set study Heparin Sodium in many different medical settings, not as one single disease treatment. The studies are mainly looking at safety, bleeding, clot prevention, and how well treatment works during procedures or intensive care.
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. 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.
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. The study compares full-dose anticoagulant therapy alone with full-dose anticoagulant therapy plus antiplatelet treatment.
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. 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.
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. Its main outcomes were arterial or venous thromboembolic events and circuit-related thrombosis, meaning clotting in the machine circuit.
The CASUAL ECMO study, NCT06442267, is a Phase 3 trial in people with respiratory insufficiency, respiratory failure, circulatory failure, or acute respiratory distress syndrome. 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.
Procedure-related anticoagulation studies
NCT05305612, the STOP CLOT Trial, studies patients undergoing transseptal procedures such as TEER and LAAC surgery. The trial is looking at the best timing for starting anticoagulation during these procedures and compares physiological saline with HEPARINUM WZF.
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. This makes the trial important for understanding both heart and brain safety after the procedure.
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. It evaluates the safety and tolerability of APAC dosing, with Heparin LEO used as part of the study treatment plan. Safety measures include treatment-emergent adverse events, physical exams, vital signs, lab data, bleeding events, and surgical adverse events.
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. 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.
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. 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.
Healthy volunteer studies
Two Phase 1 studies include healthy adult volunteers rather than patients with a disease. 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.
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. Their main endpoints are AUC and Cmax, which are measures of how much drug enters the blood and how high the blood level gets.
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.
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.
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.