Last reviewed · How we verify
TachoSil (THROMBIN)
TachoSil works by activating the coagulation cascade to form a blood clot.
At a glance
| Generic name | THROMBIN |
|---|---|
| Sponsor | Corza Medical GmbH |
| Drug class | Human Blood Coagulation Factor [EPC] |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
Mechanism of action
The mechanism of action of TachoSil is based on the interaction between the active biological substances (human fibrinogen and human thrombin) and the physiology of the fibrin clot formation (Fig. 3A) . Upon contact with a bleeding wound surface, the active substances coated onto the equine collagen patch become dissolved and partly diffuse into the wound surface. The subsequent fibrinogen-thrombin reaction initiates the last step in the cascade of biochemical reactions-conversion of fibrinogen into fibrin monomers that further polymerize to form the fibrin clot. Hemostasis is achieved when the formed fibrin clot adheres the collagen patch to the wound surface, thus providing a physical barrier to bleeding (Fig 3B) . TachoSil exhibits flexibility to accommodate for the physiological movements of tissues and organs and can withstand pressures up to 61.4 hPa (46.1 mmHg). Figure 3: Scanning Electron Microscopy Photos of TachoSil A . The side view of the TachoSil p
Approved indications
- cardiovascular surgery
- hepatic surgery
- bleeding in cardiovascular surgery
- bleeding in hepatic surgery
Common side effects
- Atrial fibrillation
- Pleural effusion
- Nausea
- Anemia
- Diarrhea
- Hypertension
- Increased transaminases
- Pyrexia
- Post-operative bile leakage
- Foreign body trauma
- Post-procedural pulmonary embolism
- Thrombosis
Key clinical trials
- Goal-Directed Hemostatic Resuscitation Trial in ACLF Induced Coagulopathy (NA)
- Monitoring of Anti-TFPI in Hemophilia
- An Observational Study of Participants With Type 3 Von Willebrand Disease on Prophylactic Standard-of-Care Treatment
- Autologous Whole Blood Management for Transfusion Reduction in Adult Cardiac Surgery Patients (NA)
- Efficacy and Safety of 4F-PCC (4-Factor Prothrombin Complex Concentrate) in Adult Patients Undergoing Complex Cardiovascular Surgery With Cardiopulmonary Bypass (CPB) (PHASE3)
- Efficacy of Platelet-rich-Fibrin Gel in Patients With Chronic Leg Ulcers (EARLY_PHASE1)
- A Trial of Intraoperative Fibrin Sealant on Postoperative Recovery After Total Knee Replacement (PHASE4)
- Testing a New Treatment Strategy to Improve Secondary Stroke Prevention for Older Adults: The STROKE75+ Trial (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |