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| ID | Type | Description | Link |
|---|---|---|---|
| BI3023_2002 | Other Identifier | CSL Behring | |
| 2007-004612-31 | EudraCT Number |
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The primary purpose is to show that administration of Haemocomplettan® P significantly reduces the amount of blood products needed during aortic surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Haemocomplettan® P | Active Comparator | Intravenous infusion during aortic surgery |
|
| Saline solution | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Haemocomplettan® P | Biological | Single intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Combined number of units of allogeneic blood products (platelets + FFP + RBCs) administered to subjects. | From administration of Haemocomplettan® P until 24 hours later |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects that receive no allogeneic blood products (neither platelets, FFP, nor RBCs) | From administration of Haemocomplettan® P until 24 hours later | |
| Duration of stay in ICU | Last suture of initial surgery to end of ICU stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Niels Rahe-Meyer, Dr. Dr. | Abteilung Anästhesiologie, Carl-Neuberg-Strasse 1 / K5, 30177 Hannover | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical School Hannover (MHH) | Hanover | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23249928 | Result | Rahe-Meyer N, Solomon C, Hanke A, Schmidt DS, Knoerzer D, Hochleitner G, Sorensen B, Hagl C, Pichlmaier M. Effects of fibrinogen concentrate as first-line therapy during major aortic replacement surgery: a randomized, placebo-controlled trial. Anesthesiology. 2013 Jan;118(1):40-50. doi: 10.1097/ALN.0b013e3182715d4d. | |
| 23410777 | Derived |
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| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| ID | Term |
|---|---|
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
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| ID | Term |
|---|---|
| D005340 | Fibrinogen |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000209 | Acute-Phase Proteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Saline solution | Biological | Single intravenous infusion |
|
| Duration of hospital stay | Last suture of initial surgery to end of hospital stay |
| Mortality | 45 days post surgery |
| Rahe-Meyer N, Hanke A, Schmidt DS, Hagl C, Pichlmaier M. Fibrinogen concentrate reduces intraoperative bleeding when used as first-line hemostatic therapy during major aortic replacement surgery: results from a randomized, placebo-controlled trial. J Thorac Cardiovasc Surg. 2013 Mar;145(3 Suppl):S178-85. doi: 10.1016/j.jtcvs.2012.12.083. |
| 20624109 | Derived | Schochl H, Posch A, Hanke A, Voelckel W, Solomon C. High-dose fibrinogen concentrate for haemostatic therapy of a major trauma patient with recent clopidogrel and aspirin intake. Scand J Clin Lab Invest. 2010 Oct;70(6):453-7. doi: 10.3109/00365513.2010.500396. |
| D001779 |
| Blood Coagulation Factors |
| D011498 | Protein Precursors |
| D001685 | Biological Factors |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |