Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT-nr:2007-007157-31 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study hypothesis is that prophylactic fibrinogen infusion reduces postoperative bleeding and transfusion requirements after coronary artery bypass surgery (CABG) in patients with endogenous fibrinogen levels in the lower normal range. 60 patients will be included in a prospective, randomized double-blind placebo-controlled single center study.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 100 ml infusion of saline is given during 15 minutes after anesthesia induction before start of surgery. |
|
| Study drug | Experimental | Fibrinogen 2g in 100 ml sterile water given during 15 minutes after anestesiainduction before surgery start |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fibrinogen | Drug | Fibrinogen 2 gr in 100 ml sterile water. The infusion is given during 15 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate safety of prophylactic fibrinogen infusion in patients with fibrinogen levels in the lower normal range undergoing cardiac surgery | 2 years | |
| Blood loss first 12 postoperative hours | 12h |
| Measure | Description | Time Frame |
|---|---|---|
| Transfusions | 7 days | |
| Biomarkers of coagulation, fibrinolysis and platelet function | 7 days | |
| Pharmcoeconomic analysis |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Anders Jeppsson, MD, PhD | Sahlgrenska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiothoracic Surgery unit, Sahlgrenska University Hospital | Gothenburg | Gothenburg | 41345 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26577034 | Derived | Jeppsson A, Walden K, Roman-Emanuel C, Thimour-Bergstrom L, Karlsson M. Preoperative supplementation with fibrinogen concentrate in cardiac surgery: A randomized controlled study. Br J Anaesth. 2016 Feb;116(2):208-14. doi: 10.1093/bja/aev367. Epub 2015 Nov 17. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D003324 | Coronary Artery Disease |
| D019106 | Postoperative Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
Not provided
Not provided
| ID | Term |
|---|---|
| D005340 | Fibrinogen |
| ID | Term |
|---|---|
| D000209 | Acute-Phase Proteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 2 years |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D011183 | Postoperative Complications |
| D001779 |
| Blood Coagulation Factors |
| D011498 | Protein Precursors |
| D001685 | Biological Factors |