Fibrinogen Concentrate vs Cryoprecipitate
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 9/27/2018 |
| Start Date: | March 2016 |
| End Date: | April 2018 |
Repurposing of Fibrinogen Concentrate as a Cost-Effective and Safe Hemostatic Agent in Infants Undergoing Cardiac Surgery on Cardiopulmonary Bypass
One of the most common hemostatic derangements in pediatric open- heart surgery is an acute
acquired hypofibrinogenemia. This compromises fibrin clot generation and platelet
aggregation, resulting in increased bleeding and allogenic blood transfusions.
Currently, fresh frozen plasma and cryoprecipitate are used to supplement fibrinogen in
pediatric cardiac patients. We propose that replacing cryoprecipitate with fibrinogen
concentrate will be as effective in treating post-CPB bleeding and will decrease total blood
product exposure when used as part of a blood transfusion algorithm.
We plan to include all patients undergoing cardiac surgery on CPB less than 12 months and a
fibrinogen level <250mg/dL while on bypass.
We hope to demonstrate that fibrinogen concentrate is at least as effective as the standard
of care in the management of peri- operative bleeding in neonatal patients undergoing
cardiopulmonary bypass. If we are able to demonstrate that fibrinogen is at least as
effective as the standard of care, then we would plan a multi-center trial to demonstrate the
safety and efficacy of this medication. If we are able to demonstrate that fibrinogen
concentrate is effective, fibrinogen concentrate could replace allogenic products and
potentially decrease transfusion related morbidity in mortality in this population.
acquired hypofibrinogenemia. This compromises fibrin clot generation and platelet
aggregation, resulting in increased bleeding and allogenic blood transfusions.
Currently, fresh frozen plasma and cryoprecipitate are used to supplement fibrinogen in
pediatric cardiac patients. We propose that replacing cryoprecipitate with fibrinogen
concentrate will be as effective in treating post-CPB bleeding and will decrease total blood
product exposure when used as part of a blood transfusion algorithm.
We plan to include all patients undergoing cardiac surgery on CPB less than 12 months and a
fibrinogen level <250mg/dL while on bypass.
We hope to demonstrate that fibrinogen concentrate is at least as effective as the standard
of care in the management of peri- operative bleeding in neonatal patients undergoing
cardiopulmonary bypass. If we are able to demonstrate that fibrinogen is at least as
effective as the standard of care, then we would plan a multi-center trial to demonstrate the
safety and efficacy of this medication. If we are able to demonstrate that fibrinogen
concentrate is effective, fibrinogen concentrate could replace allogenic products and
potentially decrease transfusion related morbidity in mortality in this population.
Patients under 12 months of age requiring cardiopulmonary bypass surgery will be approached
for the study. Patients with a pre- existing coagulopathy, including unexplained bleeding or
history of clotting, will be excluded. Prior to the study beginning, patients will be
randomized to our standard transfusion algorithm with cryoprecipitate or fibrinogen
concentrate. As is standard of care, laboratory tests will be sent at standard times points
1. after the induction of anesthesia,
2. after initiation of bypass,
3. after separation from bypass and administration of protamine,
4. on arrival to the ICU. These laboratory tests include hematocrit, arterial blood gas,
chemistry, thromboelastogram (TEG) and fibrinogen. Additional laboratory tests will be
sent as indicated by the clinical scenario to determine transfusion requirements. For
patients enrolled in the study, we will standardize the anesthetic management,
cardiopulmonary bypass protocol, and transfusion thresholds in the operating room and
ICU. We will collect demographic data, intraop and post-op laboratory values, bypass
times, intraop and post op transfusion data, chest tube output, adverse events, and
length of ventilation, ICU stay and hospital stay.
For patients randomized to the study arm (fibrinogen concentrate), the fibrinogen level
measured on bypass will be used to calculate the appropriate dose of fibrinogen concentrate
to achieve a level of 300mg/dL after separation from bypass. Fibrinogen concentrate will
replace cryoprecipitate in our post-operative transfusion algorithm. If the patient has
continued bleeding based on laboratory values and clinical situation, the patient will be
given cryoprecipitate as a rescue measure. Patients not on the study protocol will receive
our normal transfusion algorithm.
for the study. Patients with a pre- existing coagulopathy, including unexplained bleeding or
history of clotting, will be excluded. Prior to the study beginning, patients will be
randomized to our standard transfusion algorithm with cryoprecipitate or fibrinogen
concentrate. As is standard of care, laboratory tests will be sent at standard times points
1. after the induction of anesthesia,
2. after initiation of bypass,
3. after separation from bypass and administration of protamine,
4. on arrival to the ICU. These laboratory tests include hematocrit, arterial blood gas,
chemistry, thromboelastogram (TEG) and fibrinogen. Additional laboratory tests will be
sent as indicated by the clinical scenario to determine transfusion requirements. For
patients enrolled in the study, we will standardize the anesthetic management,
cardiopulmonary bypass protocol, and transfusion thresholds in the operating room and
ICU. We will collect demographic data, intraop and post-op laboratory values, bypass
times, intraop and post op transfusion data, chest tube output, adverse events, and
length of ventilation, ICU stay and hospital stay.
For patients randomized to the study arm (fibrinogen concentrate), the fibrinogen level
measured on bypass will be used to calculate the appropriate dose of fibrinogen concentrate
to achieve a level of 300mg/dL after separation from bypass. Fibrinogen concentrate will
replace cryoprecipitate in our post-operative transfusion algorithm. If the patient has
continued bleeding based on laboratory values and clinical situation, the patient will be
given cryoprecipitate as a rescue measure. Patients not on the study protocol will receive
our normal transfusion algorithm.
Inclusion Criteria:
- Neonates of at least 32 weeks of gestational age and infants up to 12 months of age
with the diagnosis of congenital heart disease, requiring open heart surgery with
cardiopulmonary bypass
Exclusion Criteria:
- Pre-existing coagulopathy, including unexplained bleeding or history of clotting
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