Hemostasis
Conditions
Keywords
Fibrinogen Concentrate, FC, Cryoprecipitate, Transfusion, in vivo, Open-heart surgery, Cardiopulmonary Bypass, Fibrin Network Structure
Brief summary
This primary aim of this study is to compare the in vivo effects of fibrinogen concentrate and cryoprecipitate on the neonatal fibrin network after surgery with cardiopulmonary bypass to develop effective and safe strategies for managing coagulopathies in neonates.
Detailed description
This study is a prospective, randomized control trial comparing two different sources of fibrinogen on clot kinetics (degradation and structure) in post-CPB coagulopathy in neonates undergoing cardiac surgery. The two sources of fibrinogen include the blood product, cryoprecipitate, and a blood product alternative, fibrinogen concentrate. Cryoprecipitate is an allogenic blood product that requires cross-matching and thawing prior to administration and is associated with immunologic reactions and possible pathogen transmission. Fibrinogen concentrate, a blood product alternative, is a purified form of fibrinogen, which undergoes a pasteurization process to minimize the risk of immunologic and allergic reactions. The primary aim of this study is compare the in vivo effect of post-CPB administration of FC, a blood product alternative, to cryoprecipitate on neonatal clot properties and clinical outcomes.
Interventions
DRUGFibrinogen Concentrate (FC)
The dose of fibrinogen concentrate will be calculated to achieve a level of 300mg/dL after drug administration.
DRUGCryoprecipitate
The standard transfusion algorithm includes two units of cryoprecipitate, which result in a median post-operative fibrinogen level of 286mg/dL.
Sponsors
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 30 Days
Healthy volunteers
No
Inclusion criteria
1. Full term neonates (36-42 weeks gestational age) 2. Infants =\< 30 days of age at time of surgery 3. APGAR score of 6 or greater at 5 minutes after delivery 4. Neonates undergoing elective cardiac surgery requiring CPB at Children's Healthcare of Atlanta 5. Parents willing to participate and able to understand and sign the provided informed consent
Exclusion criteria
1. Preterm neonates (less than 36 weeks gestation) 2. Patients undergoing an emergent procedure or surgery not requiring CPB 3. Patients with personal or family history of a coagulation defect or coagulopathy 4. Parents unwilling to participate or unable to understand and sign the provided informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clot Degradation at 24 Hours Post-operatively | From induction of anesthesia to 24 hours postoperatively | Blood samples were obtained from an arterial line that was required for the planned surgical procedure. Samples were centrifuged to yield platelet poor plasma (PPP), stored at -80 degrees Celsius and utilized for the clot analysis. Clot degradation was determined by degradation kinetic study. Blood samples were collected at four time points:1) baseline sample within 24 hours of surgery and after induction of anesthesia prior to CPB; 2) after termination of CPB and transfusion of platelets and either cryoprecipitate or fibrinogen (within 1 hour of separation from bypass; 3) upon arrival to the ICU; 4) 24 hours post-operatively. The primary outcome is to examine differences in clot degradation between study arms at 24 hours post-surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Interoperative Transfusion Requirement | During surgery (up to 6 hours) | Blood product transfusion requirements were obtained from electronic medical records. An increased transfusion requirement indicates increased interoperative bleeding, thus, lower values are preferable. |
| Amount of Post-operative Bleeding | Up to 24 hours postoperatively | Post-operative bleeding was recorded by 24 hour chest tube output. Higher values indicate greater post-operative bleeding. |
| Mechanical Ventilation Time | Time of extubation (up to 2 weeks) | Mechanical ventilation time was obtained from medical records. Higher values indicate increased need for mechanical ventilation. |
| Length of ICU Stay | At discharge from ICU (typically up to 21 days) | Length of ICU stay was obtained from medical records. A shorter ICU stay indicates a favorable state of health. |
| Length of Hospital Stay | At discharge from hospital (up to 150 days) | Length of hospital stay was obtained from medical records. A shorter hospital stay indicates a favorable state of health. |
| Number of Adverse Events | Within seven days of surgery | Adverse events within seven days of surgery were obtained from medical records. |
| Clot Strength | From induction of anesthesia to 24 hours postoperatively | Blood samples will be obtained from an arterial line that is required for the planned surgical procedure. They will be centrifuged to yield platelet poor plasma (PPP), stored at -80 degrees Celsius and utilized for the clot analysis. Strength will be assessed by rheology and atomic force microscopy (AFM). |
| Clot Polymerization Kinetic | From induction of anesthesia to 24 hours postoperatively | Blood samples will be obtained from an arterial line that is required for the planned surgical procedure. They will be centrifuged to yield platelet poor plasma (PPP), stored at -80 degrees Celsius and utilized for the clot analysis. Polymerization will be determined by thrombin-initiated turbidity/absorbency curves. |
| Fibrin Fiber Alignment | From induction of anesthesia to 24 hours postoperatively | Clot structure is assessed by examination of images of clot fibrin fiber alignment. Quantification of clot fiber alignment was achieved through the application of an automated algorithm based on a fast Fourier transform that measures the alignment of the fibers, as well as visual inspection. A reference range has not been established for neonates, however, higher values indicate more dense clot structure. |
| Transfusion Requirements Within the First 24 Hours After Surgery | 24 hours postoperatively | Transfusion requirements within the first 24 hours of surgery were obtained from electronic medical records. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Thrombin Plasma Level | From induction of anesthesia to 24 hours postoperatively | Blood samples were obtained from an arterial line that was required for the planned surgical procedure. The samples were centrifuged to yield platelet poor plasma (PPP), stored at -80 degrees Celsius and utilized for the clot analysis. ELISA was used to measure coagulation factors at each time point. The reference range for thrombin plasma level is 0.000313 to 0.02 mcg/mL. |
| FXIII Plasma Level | From induction of anesthesia to 24 hours postoperatively | Blood samples were obtained from an arterial line that was required for the planned surgical procedure. The samples were centrifuged to yield platelet poor plasma (PPP), stored at -80 degrees Celsius and utilized for the clot analysis. ELISA was used to measure coagulation factors at each time point. The reference range for FXIII plasma level is 0.000469 to 0.03 mcg/mL. |
| Von Willebrand Factor Plasma Level | From induction of anesthesia to 24 hours postoperatively | Blood samples were obtained from an arterial line that was required for the planned surgical procedure. The samples were centrifuged to yield platelet poor plasma (PPP), stored at -80 degrees Celsius and utilized for the clot analysis. ELISA was used to measure coagulation factors at each time point. Lower values may indicate an increased risk of excessive bleeding. |
| Fibrinogen Plasma Level | From induction of anesthesia to 24 hours postoperatively | Blood samples were obtained from an arterial line that was required for the planned surgical procedure. The samples were centrifuged to yield platelet poor plasma (PPP), stored at -80 degrees Celsius and utilized for the clot analysis. ELISA was used to measure coagulation factors at each time point. Normal fibrinogen plasma values are between 0.5 to 15 mcg/mL. |
| Number of Events of Postoperative Thrombosis | Within the first 24 hours of surgery | The number of events of clinically significant postoperative thrombosis that required treatment were obtained from medical records. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from Children's Healthcare of Atlanta (CHOA) at Egleston in Atlanta, Georgia, USA. Participant enrollment began August 13, 2019 and all follow up was complete by November 16, 2021.
Participants by arm
| Arm | Count |
|---|---|
| Fibrinogen Concentrate (FC) Neonates undergoing elective cardiac surgery requiring cardiopulmonary bypass (CPB) who were randomized to receive platelets and fibrinogen concentrate after separation from bypass. | 18 |
| Cryoprecipitate Neonates undergoing elective cardiac surgery requiring cardiopulmonary bypass (CPB) who were randomized to receive platelets and cryoprecipitate after separation from bypass. | 18 |
| Total | 36 |
Baseline characteristics
| Characteristic | Fibrinogen Concentrate (FC) | Cryoprecipitate | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 18 Participants | 18 Participants | 36 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 16 Participants | 31 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 8 Participants | 13 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 12 Participants | 10 Participants | 22 Participants |
| Region of Enrollment United States | 18 Participants | 18 Participants | 36 Participants |
| Sex: Female, Male Female | 9 Participants | 4 Participants | 13 Participants |
| Sex: Female, Male Male | 9 Participants | 14 Participants | 23 Participants |
| Weight | 3.10 kilograms (kg) | 3.50 kilograms (kg) | 3.40 kilograms (kg) |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 18 | 1 / 18 |
| other Total, other adverse events | 4 / 18 | 6 / 18 |
| serious Total, serious adverse events | 2 / 18 | 9 / 18 |
Outcome results
Primary
Clot Degradation at 24 Hours Post-operatively
Blood samples were obtained from an arterial line that was required for the planned surgical procedure. Samples were centrifuged to yield platelet poor plasma (PPP), stored at -80 degrees Celsius and utilized for the clot analysis. Clot degradation was determined by degradation kinetic study. Blood samples were collected at four time points:1) baseline sample within 24 hours of surgery and after induction of anesthesia prior to CPB; 2) after termination of CPB and transfusion of platelets and either cryoprecipitate or fibrinogen (within 1 hour of separation from bypass; 3) upon arrival to the ICU; 4) 24 hours post-operatively. The primary outcome is to examine differences in clot degradation between study arms at 24 hours post-surgery.
Time frame: From induction of anesthesia to 24 hours postoperatively
Population: This analysis includes the Intent to Treat Population, which is comprised on all participants regardless of if they completed the study per protocol.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fibrinogen Concentrate (FC) | Clot Degradation at 24 Hours Post-operatively | After induction of anesthesia prior to CPB | 0.65 microns per hour |
| Fibrinogen Concentrate (FC) | Clot Degradation at 24 Hours Post-operatively | After termination of CPB and transfusion of platelets and either cryoprecipitate or fibrinogen | 0.78 microns per hour |
| Fibrinogen Concentrate (FC) | Clot Degradation at 24 Hours Post-operatively | Upon arrival to the ICU | 0.65 microns per hour |
| Fibrinogen Concentrate (FC) | Clot Degradation at 24 Hours Post-operatively | 24 hours post-operatively | 0.92 microns per hour |
| Cryoprecipitate | Clot Degradation at 24 Hours Post-operatively | 24 hours post-operatively | 0.76 microns per hour |
| Cryoprecipitate | Clot Degradation at 24 Hours Post-operatively | After induction of anesthesia prior to CPB | 0.88 microns per hour |
| Cryoprecipitate | Clot Degradation at 24 Hours Post-operatively | Upon arrival to the ICU | 0.55 microns per hour |
| Cryoprecipitate | Clot Degradation at 24 Hours Post-operatively | After termination of CPB and transfusion of platelets and either cryoprecipitate or fibrinogen | 0.46 microns per hour |
Secondary
Amount of Post-operative Bleeding
Post-operative bleeding was recorded by 24 hour chest tube output. Higher values indicate greater post-operative bleeding.
Time frame: Up to 24 hours postoperatively
Population: This analysis includes the Intent to Treat Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Fibrinogen Concentrate (FC) | Amount of Post-operative Bleeding | 38.5 ml/kg |
| Cryoprecipitate | Amount of Post-operative Bleeding | 45.5 ml/kg |
Secondary
Clot Polymerization Kinetic
Blood samples will be obtained from an arterial line that is required for the planned surgical procedure. They will be centrifuged to yield platelet poor plasma (PPP), stored at -80 degrees Celsius and utilized for the clot analysis. Polymerization will be determined by thrombin-initiated turbidity/absorbency curves.
Time frame: From induction of anesthesia to 24 hours postoperatively
Population: Due to the maximum allowable blood to be taken from a neonate, there was not enough remaining blood available to examine clot polymerization kinetics. In order to carry out the degradation assay on neonatal fibrinogen, the study team improved the assay they originally intended to use and no longer did polymerization assays as part of the degradation assay. Due to the change in the degradation assay, the team was not able to collect additional blood for the clot polymerization kinetics assay.
Secondary
Clot Strength
Blood samples will be obtained from an arterial line that is required for the planned surgical procedure. They will be centrifuged to yield platelet poor plasma (PPP), stored at -80 degrees Celsius and utilized for the clot analysis. Strength will be assessed by rheology and atomic force microscopy (AFM).
Time frame: From induction of anesthesia to 24 hours postoperatively
Population: Unfortunately, due to the required amount of blood necessary for triplicates of the primary outcome, there was not enough blood to examine clot strength. Due to the small amount of blood collected from neonates the samples were used for the outcome measures with the highest priority and the amount of remaining blood was not sufficient to assess clot strength.
Secondary
Fibrin Fiber Alignment
Clot structure is assessed by examination of images of clot fibrin fiber alignment. Quantification of clot fiber alignment was achieved through the application of an automated algorithm based on a fast Fourier transform that measures the alignment of the fibers, as well as visual inspection. A reference range has not been established for neonates, however, higher values indicate more dense clot structure.
Time frame: From induction of anesthesia to 24 hours postoperatively
Population: This analysis includes the Intent to Treat Population.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fibrinogen Concentrate (FC) | Fibrin Fiber Alignment | After induction of anesthesia prior to CPB | 0.46 black/white pixels |
| Fibrinogen Concentrate (FC) | Fibrin Fiber Alignment | After termination of CPB and transfusion of platelets and either cryoprecipitate or fibrinogen | 0.52 black/white pixels |
| Fibrinogen Concentrate (FC) | Fibrin Fiber Alignment | Upon arrival to the ICU | 0.41 black/white pixels |
| Fibrinogen Concentrate (FC) | Fibrin Fiber Alignment | 24 hours post-operatively | 0.37 black/white pixels |
| Cryoprecipitate | Fibrin Fiber Alignment | 24 hours post-operatively | 0.38 black/white pixels |
| Cryoprecipitate | Fibrin Fiber Alignment | After induction of anesthesia prior to CPB | 0.54 black/white pixels |
| Cryoprecipitate | Fibrin Fiber Alignment | Upon arrival to the ICU | 0.44 black/white pixels |
| Cryoprecipitate | Fibrin Fiber Alignment | After termination of CPB and transfusion of platelets and either cryoprecipitate or fibrinogen | 0.54 black/white pixels |
Secondary
Interoperative Transfusion Requirement
Blood product transfusion requirements were obtained from electronic medical records. An increased transfusion requirement indicates increased interoperative bleeding, thus, lower values are preferable.
Time frame: During surgery (up to 6 hours)
Population: This analysis includes the Intent to Treat Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Fibrinogen Concentrate (FC) | Interoperative Transfusion Requirement | 27.2 ml/kg |
| Cryoprecipitate | Interoperative Transfusion Requirement | 41.6 ml/kg |
Secondary
Length of Hospital Stay
Length of hospital stay was obtained from medical records. A shorter hospital stay indicates a favorable state of health.
Time frame: At discharge from hospital (up to 150 days)
Population: This analysis includes the Intent to Treat Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Fibrinogen Concentrate (FC) | Length of Hospital Stay | 16.0 days |
| Cryoprecipitate | Length of Hospital Stay | 14.5 days |
Secondary
Length of ICU Stay
Length of ICU stay was obtained from medical records. A shorter ICU stay indicates a favorable state of health.
Time frame: At discharge from ICU (typically up to 21 days)
Population: This analysis includes the Intent to Treat Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Fibrinogen Concentrate (FC) | Length of ICU Stay | 7.0 days |
| Cryoprecipitate | Length of ICU Stay | 8.5 days |
Secondary
Mechanical Ventilation Time
Mechanical ventilation time was obtained from medical records. Higher values indicate increased need for mechanical ventilation.
Time frame: Time of extubation (up to 2 weeks)
Population: This analysis includes the Intent to Treat Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Fibrinogen Concentrate (FC) | Mechanical Ventilation Time | 63.3 hours |
| Cryoprecipitate | Mechanical Ventilation Time | 117.2 hours |
Secondary
Number of Adverse Events
Adverse events within seven days of surgery were obtained from medical records.
Time frame: Within seven days of surgery
Population: This analysis includes the Intent to Treat Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fibrinogen Concentrate (FC) | Number of Adverse Events | 6 adverse events |
| Cryoprecipitate | Number of Adverse Events | 11 adverse events |
Secondary
Transfusion Requirements Within the First 24 Hours After Surgery
Transfusion requirements within the first 24 hours of surgery were obtained from electronic medical records.
Time frame: 24 hours postoperatively
Population: The recording of transfusions in the intensive care unit (ICU) changed in the middle of this study and therefore transfusions were not consistently documented by the clinical staff, thus, the study investigators decided to not collect information about transfusions up to 24 hours after surgery from medical records as data could not be reliably analyzed.
Other Pre-specified
Fibrinogen Plasma Level
Blood samples were obtained from an arterial line that was required for the planned surgical procedure. The samples were centrifuged to yield platelet poor plasma (PPP), stored at -80 degrees Celsius and utilized for the clot analysis. ELISA was used to measure coagulation factors at each time point. Normal fibrinogen plasma values are between 0.5 to 15 mcg/mL.
Time frame: From induction of anesthesia to 24 hours postoperatively
Population: This analysis includes the Intent to Treat Population.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fibrinogen Concentrate (FC) | Fibrinogen Plasma Level | Within 2 hours of induction of anesthesia prior to CPB | 1.39 mcg/mL |
| Fibrinogen Concentrate (FC) | Fibrinogen Plasma Level | After termination of CPB and transfusion of platelets and either cryoprecipitate or fibrinogen | 1.26 mcg/mL |
| Fibrinogen Concentrate (FC) | Fibrinogen Plasma Level | Upon arrival to the ICU | 1.42 mcg/mL |
| Fibrinogen Concentrate (FC) | Fibrinogen Plasma Level | 24 hours post-operatively | 1.76 mcg/mL |
| Cryoprecipitate | Fibrinogen Plasma Level | 24 hours post-operatively | 1.87 mcg/mL |
| Cryoprecipitate | Fibrinogen Plasma Level | Within 2 hours of induction of anesthesia prior to CPB | 1.09 mcg/mL |
| Cryoprecipitate | Fibrinogen Plasma Level | Upon arrival to the ICU | 1.28 mcg/mL |
| Cryoprecipitate | Fibrinogen Plasma Level | After termination of CPB and transfusion of platelets and either cryoprecipitate or fibrinogen | 1.97 mcg/mL |
Other Pre-specified
FXIII Plasma Level
Blood samples were obtained from an arterial line that was required for the planned surgical procedure. The samples were centrifuged to yield platelet poor plasma (PPP), stored at -80 degrees Celsius and utilized for the clot analysis. ELISA was used to measure coagulation factors at each time point. The reference range for FXIII plasma level is 0.000469 to 0.03 mcg/mL.
Time frame: From induction of anesthesia to 24 hours postoperatively
Population: This analysis includes the Intent to Treat Population.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fibrinogen Concentrate (FC) | FXIII Plasma Level | Within 2 hours of induction of anesthesia prior to CPB | 0.03 mcg/mL |
| Fibrinogen Concentrate (FC) | FXIII Plasma Level | After termination of CPB and transfusion of platelets and either cryoprecipitate or fibrinogen | 0.04 mcg/mL |
| Fibrinogen Concentrate (FC) | FXIII Plasma Level | Upon arrival to the ICU | 0.04 mcg/mL |
| Fibrinogen Concentrate (FC) | FXIII Plasma Level | 24 hours post-operatively | 0.03 mcg/mL |
| Cryoprecipitate | FXIII Plasma Level | 24 hours post-operatively | 0.04 mcg/mL |
| Cryoprecipitate | FXIII Plasma Level | Within 2 hours of induction of anesthesia prior to CPB | 0.03 mcg/mL |
| Cryoprecipitate | FXIII Plasma Level | Upon arrival to the ICU | 0.05 mcg/mL |
| Cryoprecipitate | FXIII Plasma Level | After termination of CPB and transfusion of platelets and either cryoprecipitate or fibrinogen | 0.04 mcg/mL |
Other Pre-specified
Number of Events of Postoperative Thrombosis
The number of events of clinically significant postoperative thrombosis that required treatment were obtained from medical records.
Time frame: Within the first 24 hours of surgery
Population: This analysis includes the Intent to Treat Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fibrinogen Concentrate (FC) | Number of Events of Postoperative Thrombosis | 2 events |
| Cryoprecipitate | Number of Events of Postoperative Thrombosis | 2 events |
Other Pre-specified
Thrombin Plasma Level
Blood samples were obtained from an arterial line that was required for the planned surgical procedure. The samples were centrifuged to yield platelet poor plasma (PPP), stored at -80 degrees Celsius and utilized for the clot analysis. ELISA was used to measure coagulation factors at each time point. The reference range for thrombin plasma level is 0.000313 to 0.02 mcg/mL.
Time frame: From induction of anesthesia to 24 hours postoperatively
Population: This analysis includes the Intent to Treat Population.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fibrinogen Concentrate (FC) | Thrombin Plasma Level | Within 2 hours of induction of anesthesia prior to CPB | 0.02 mcg/mL |
| Fibrinogen Concentrate (FC) | Thrombin Plasma Level | After termination of CPB and transfusion of platelets and either cryoprecipitate or fibrinogen | 0.02 mcg/mL |
| Fibrinogen Concentrate (FC) | Thrombin Plasma Level | Upon arrival to the ICU | 0.03 mcg/mL |
| Fibrinogen Concentrate (FC) | Thrombin Plasma Level | 24 hours post-operatively | 0.02 mcg/mL |
| Cryoprecipitate | Thrombin Plasma Level | 24 hours post-operatively | 0.06 mcg/mL |
| Cryoprecipitate | Thrombin Plasma Level | Within 2 hours of induction of anesthesia prior to CPB | 0.07 mcg/mL |
| Cryoprecipitate | Thrombin Plasma Level | Upon arrival to the ICU | 0.05 mcg/mL |
| Cryoprecipitate | Thrombin Plasma Level | After termination of CPB and transfusion of platelets and either cryoprecipitate or fibrinogen | 0.05 mcg/mL |
Other Pre-specified
Von Willebrand Factor Plasma Level
Blood samples were obtained from an arterial line that was required for the planned surgical procedure. The samples were centrifuged to yield platelet poor plasma (PPP), stored at -80 degrees Celsius and utilized for the clot analysis. ELISA was used to measure coagulation factors at each time point. Lower values may indicate an increased risk of excessive bleeding.
Time frame: From induction of anesthesia to 24 hours postoperatively
Population: This analysis includes the Intent to Treat Population.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fibrinogen Concentrate (FC) | Von Willebrand Factor Plasma Level | Within 2 hours of induction of anesthesia prior to CPB | 2.98 IU/mL |
| Fibrinogen Concentrate (FC) | Von Willebrand Factor Plasma Level | After termination of CPB and transfusion of platelets and either cryoprecipitate or fibrinogen | 4.43 IU/mL |
| Fibrinogen Concentrate (FC) | Von Willebrand Factor Plasma Level | Upon arrival to the ICU | 5.06 IU/mL |
| Fibrinogen Concentrate (FC) | Von Willebrand Factor Plasma Level | 24 hours post-operatively | 3.95 IU/mL |
| Cryoprecipitate | Von Willebrand Factor Plasma Level | 24 hours post-operatively | 7.00 IU/mL |
| Cryoprecipitate | Von Willebrand Factor Plasma Level | Within 2 hours of induction of anesthesia prior to CPB | 4.68 IU/mL |
| Cryoprecipitate | Von Willebrand Factor Plasma Level | Upon arrival to the ICU | 6.15 IU/mL |
| Cryoprecipitate | Von Willebrand Factor Plasma Level | After termination of CPB and transfusion of platelets and either cryoprecipitate or fibrinogen | 6.11 IU/mL |