CLINICAL TRIALS PROFILE FOR TACHOSIL
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All Clinical Trials for TACHOSIL
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00285623 ↗ | Observational Cohort Study of TachoSil (TC-018-IN) | Completed | Nycomed | 2005-12-01 | The purpose of this study is to collect information, after exposure to TachoSil ®, of all thromboembolic events, immunological events and drug interactions leading to thromboembolic events or major bleeding. In addition, pharmacoeconomic data will be collected. | |
| NCT00293514 ↗ | TachoSil Versus Standard Surgical Treatment for Air Leakage in Pulmonary Lobectomy (TC-021-IM) | Completed | Nycomed | Phase 3 | 2006-02-01 | The purpose of this study is to compare the sealing efficacy and safety of TachoSil® (hereafter referred to as TachoSil) versus standard surgical treatment as the secondary management of intra-operative pulmonary air leakage after a lobectomy in subjects with lung malignancies with or without metastases. |
| NCT00365248 ↗ | TachoSil Paediatric Liver Trial (TC-019-IN) | Completed | Nycomed | Phase 3 | 2005-10-01 | The overall objective is to assess the haemostatic efficacy and safety of TachoSil for control of local bleeding in paediatric patients undergoing surgical resection of the liver with our without segmental liver transplantation. |
| NCT00440401 ↗ | TachoSil® Versus Standard Haemostatic Treatment of Haemorrhage in Cardiovascular Surgery (TC-023-IM) | Completed | Nycomed | Phase 4 | 2007-02-01 | To demonstrate efficacy and safety of TachoSil® in cardiovascular surgery |
| NCT00546169 ↗ | Non-interventional Trial About Treatment of Haemorrhages in Cholecystectomy With TachoSil (TC-027-DE) | Completed | Nycomed | 2007-06-01 | - Effectiveness and reliability of TachoSil in cholecystectomy (elective and acute) - Evaluation of TachoSil in laparoscopic cholecystectomy - Risk profile of patient under anticoagulant therapy undergoing acute cholecystectomy - Pharmaco-economic evaluation - Recording of AE's/SAE's Considering the total number of cholecystectomies in Germany (170.000 cases/y), out of them about 75% laparoscopic and 10.000 conversions totally it seems urgent to record data about usage of TachoSil in such procedures. For the time being TachoSil is applied in about 2% of the gall bladder procedures. Aim is to evaluate a possible patient and procedure profile where TachoSil is most beneficial. | |
| NCT00713661 ↗ | Evaluation of TachoSil® Application on a Colorectal Anastomosis (TC-029-IM) | Completed | Nycomed | Phase 2 | 2008-06-01 | The primary objective is to evaluate if the application of TachoSil® on a colorectal anastomosis is feasible and safe. The secondary objective is to establish and describe optimal application methods to be used for educational purposes in future trials. |
| NCT00918619 ↗ | Efficacy and Safety of Sangustop® as Haemostatic Agent Versus a Carrier-Bound Fibrin Sealant During Liver Resection | Completed | Aesculap AG | Phase 4 | 2010-01-01 | This is a multi-centre, patient-blinded, intra-operatively randomised controlled trial. A total of 126 patients planned for an elective liver resection will be enrolled in 9 surgical centres. The primary objective of this study is to show that the collagen based haemostatic device Sangustop® is not inferior to a carrier-bound fibrin sealant (Tachosil®) in achieving haemostasis after hepatic resection. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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