Safety of rFXIII in Patients Following First Time Myocardial Revascularization Requiring Cardiopulmonary Bypass
| Status: | Completed |
|---|---|
| Conditions: | Hematology |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 35 - 70 |
| Updated: | 1/12/2017 |
| Start Date: | October 2005 |
| End Date: | January 2008 |
A Multi-Centre, Randomised, Double-Blind, Placebo Controlled, Dose Escalation Trial on Safety and Pharmacokinetics of Recombinant Factor XIII (rFXIII) in Patients Following First Time Myocardial Revascularization Requiring Cardiopulmonary Bypass
This trial is conducted in Europe and the United States of America (USA). The aim of this
trial is to evaluate the safety of escalating single doses of rFXIII (recombinant factor
XIII, catridecacog) administered following first time myocardial revascularization requiring
cardiopulmonary bypass (CPB).
trial is to evaluate the safety of escalating single doses of rFXIII (recombinant factor
XIII, catridecacog) administered following first time myocardial revascularization requiring
cardiopulmonary bypass (CPB).
Inclusion Criteria:
- Subject is undergoing his/her first myocardial revascularization
Exclusion Criteria:
- Previous participation (randomisation and dosing) in this trial
- Subject has a history of cerebrovascular event (including thrombotic or haemorrhagic
stroke or transient ischaemic attack (TIA)) and/or extra-myocardial thromboembolic
events, e.g., deep vein thrombosis (DVT) or pulmonary embolus (PE)
- Subject required a pre-operative (within 30 days) transfusion of any blood and/or
blood product
- Subject has a current atrial fibrillation or history of atrial fibrillation
We found this trial at
14
sites
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