Cardiac Complication During Procedure Clinical Trial
Official title:
The Use of Fibrinogen Concentrate in High-Risk Cardiac Surgery. A Prospective, Double-blinded, Randomized, Controlled Study
| Verified date | May 2020 |
| Source | Nova Scotia Health Authority |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The aim of the study is to show that first line treatment with concentrated fibrinogen has superiority over the conventional therapy with fresh frozen plasma (FFP), platelets, and cryoprecipitate in perioperative management of bleeding after complex cardiac surgery.
| Status | Completed |
| Enrollment | 62 |
| Est. completion date | June 30, 2019 |
| Est. primary completion date | March 31, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: All patients who are scheduled for elective complex cardiac surgical procedures including - double procedures (aortic valve replacement (AVR)+CABG, mitral valve repair/replacement (MVR)+CABG, AVR+MVR) - Redo-sternotomies - Aortic root repair +/- AVR Exclusion Criteria: - Any known congenital or pre-existing bleeding disorder - pre-existing clinically significant abnormal fibrinogen level (normal: 2.5-4.79g/l) - severe liver disease (alanine aminotransferase or aspartate aminotransferase > 150 U/l) - inability to provide informed consent - emergency surgery - pregnancy or nursing - age under 18 years - intake of anti-platelet drugs within2- 5 days preoperatively (low dose ASA is allowed) - allergy to concentrated fibrinogen or other components in the product - anemia (Hgb < 110) - diagnosed deep vein thrombosis (DVT) - pulmonary embolism - acute stroke - acute myocardial infarction |
| Country | Name | City | State |
|---|---|---|---|
| Canada | CapitalDHACanada | Halifax | Nova Scotia |
| Lead Sponsor | Collaborator |
|---|---|
| Nova Scotia Health Authority |
Canada,
Kwapisz MM, Kent B, DiQuinzio C, LeGare JF, Garnett S, Swyer W, Whynot S, Mingo H, Scheffler M. The prophylactic use of fibrinogen concentrate in high-risk cardiac surgery. Acta Anaesthesiol Scand. 2020 May;64(5):602-612. doi: 10.1111/aas.13540. Epub 2020 Jan 17. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Overall Numbers of Patients Receiving Blood Products | Including Packed Red Cells, Fresh Frozen Plasma, Platelets, Cryoprecipitate and coagulation factor concentrates. The study was not sufficiently powered to test differences between this outcome. | 24 hours after administration of study drug | |
| Primary | Cumulative Transfusion Units | Including packed red cells, frozen plasma, platelets, cryoprecipitates | 24 hours after administration of study drug | |
| Secondary | Fibrinogen Plasma Concentration (g/L) | 24h after infusion of study drug | ||
| Secondary | Hematocrit (%) | 24h after infusion of study drug | ||
| Secondary | Hemoglobin Concentration (g/L) | 24h after infusion of study drug | ||
| Secondary | Platelet Count (10^3/µL) | 24h after infusion of study drug | ||
| Secondary | Partial Thromboplastin Time (s) | 24h after infusion of study drug | ||
| Secondary | International Normalized Ratio | International normalized ratio (INR) is calculated based on the prothrombin time (PT) test results.The PT is usually measured in seconds and is compared to a normal range that reflects PT values in healthy individuals. Because the reagents used to perform the PT test vary from one laboratory to another and even within the same laboratory over time, the normal ranges also will fluctuate. To standardize results across different laboratories in the world, a World Health Organization (WHO) committee developed and recommended the use of the Internationalized Normalized Ratio (INR). The INR is calculated with the ratio of the patient's prothrombin time (PT test) to a normal prothrombin time (control) sample (PT normal): INR=PT test:PT normal. The normal range is from 0.9 to 1.2. The higher the value the more is the patient anticoagulated. This means the patient's blood is thinner with a lower concentration of coagulation factors. | 24h after infusion of study drug | |
| Secondary | Prothrombin Time (s) | The prothrombin time (PT) test evaluates how well all of the coagulation factors in the extrinsic and common pathways of the coagulation cascade work together. Included are: factors I (Fibrinogen), II (Prothrombin), V, VII and X. | 24h after infusion of study drug | |
| Secondary | EXTEM Clotting Time (s) | EXTEM = rotational thrombelastometry (measurement of extrinsic coagulation pathway); clotting time: time from start of the measurement until initiation of clotting (thrombin formation, start of clot polymerisation). | 24h after infusion of study drug | |
| Secondary | EXTEM Maximum Clot Firmness (mm) | EXTEM = rotational thrombelastometry (measurement of extrinsic coagulation pathway); maximum clot firmness: increasing stabilisation of the clot by the polymerised fibrin, platelets as well as factor XIII. | 24h after infusion of study drug | |
| Secondary | INTEM Clotting Time (s) | INTEM = rotational thrombelastometry (measurement of intrinsic coagulation pathway); clotting time: time from start of the measurement until initiation of clotting (thrombin formation, start of clot polymerisation). | 24h after infusion of study drug | |
| Secondary | INTEM Maximum Clot Firmness (mm) | INTEM = rotational thrombelastometry (measurement of intrinsic coagulation pathway); maximum clot firmness: increasing stabilisation of the clot by the polymerised fibrin, platelets as well as factor XIII. | 24h after infusion of study drug | |
| Secondary | FIBTEM Clotting Time (s) | FIBTEM = rotational thrombelastometry (measurement of functional fibrinogen); clotting time: time from start of the measurement until initiation of clotting (thrombin formation, start of clot polymerisation). | 24h after infusion of study drug | |
| Secondary | FIBTEM MCF (Maximum Clot Firmness) | Rotational thrombelastometry (measurement of functional fibrinogen). Rotational thrombelastometry (ROTEM) is a point-of-care viscoelastic coagulation test. The device provides four channels for simultaneous assays. With the so called "FIBTEM" assay coagulation is activated by a small amount of tissue thromboplastin (tissue factor) and platelets are blocked with cytochalasin D. The resulting clot is therefore only depending on fibrin formation and fibrin polymerisation. The maximum clot firmness (MCF) is the amplitude in mm on the result graph representing the increasing stabilisation of the clot. | 24 hours after study drug administration | |
| Secondary | HEPTEM Clotting Time (s) | HEPTEM = rotational thrombelastometry (measurement of INTEM with heparinase);clotting time: time from start of the measurement until initiation of clotting (thrombin formation, start of clot polymerisation). | 24h after infusion of study drug | |
| Secondary | HEPTEM Maximum Clot Firmness (mm) | HEPTEM = rotational thrombelastometry (measurement of INTEM with heparinase); maximum clot firmness: increasing stabilisation of the clot by the polymerised fibrin, platelets as well as factor XIII. | 24h after infusion of study drug | |
| Secondary | Total Avoidance of Transfusions | Total avoidance of any transfusion after cardiopulmonary bypass (CPB) 24h after administration of study drug or placebo. | 24h after infusion of study drug |