Hypofibrinogenemia, Afibrinogenemia, Bleeding Disorders
Conditions
Keywords
CBP, congenital heart defects, cardiopulmonary bypass
Brief summary
The goal of the study is to determine whether the use of Human Fibrinogen Concentrate (RiaSTAP) will decrease blood loss and the need for component blood therapy in neonates and infants undergoing cardiopulmonary bypass.
Detailed description
The goal of the study is to determine whether the use of Human Fibrinogen Concentrate (RiaSTAP) will decrease blood loss and the need for component blood therapy in neonates and infants undergoing cardiopulmonary bypass. RiaSTAP will be administered after termination of Cardiopulmonary Bypass (CPB) at a dose of 70 mg/kg, in a prospective, randomized, controlled study. We hypothesize that the administration of RiaSTAP in this manner will reduce peri-operative bleeding and transfusion requirements.
Interventions
DRUGRiaStAP
To decrease post-operative bleeding volume.
DRUGSaline
Placebo consisting of normal saline 0.9%
Sponsors
Nicklaus Children's Hospital f/k/a Miami Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Days to 1 Years
Healthy volunteers
No
Inclusion criteria
* Neonatal and infant cardiac patients presenting for open-heart surgery at Nicklaus Children's Hospital will be eligible for enrollment in the study.
Exclusion criteria
* Patients who fall outside of the age range for the study will be excluded. Patients known to have had an anaphylactic or severe reaction to the drug or its components will not be enrolled. At the time of the rewarming ROTEM, any patient with a FIBTEM MCF \> 15mm, will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative 24 hr Fibrinogen mg/dL | 24 hour | Post-operative 24 hr Fibrinogen between the treatment and placebo group |
| Post-operative 24 hr Partial Thromboplastin Time (PTT) Seconds | 24 hour | Post-operative 24 hr Partial Thromboplastin Time (PTT) between the treatment and placebo group. A transfusion algorithm was developed based on three previous studies, modified for pediatrics. Clinically significant bleeding requiring treatment was defined as a rate \>10 cc kg-1 hr-1 calculated every 15 minutes while in the OR, measured by blood in the suction canister. In cases of continued bleeding following randomization to HFC or placebo, cryoprecipitate was considered for fibrinogen \<200 mg/dL or FIBTEM MCF \<7 mm. Once the patient left the OR, ROTEM was performed at least every 60 minutes for the first 6 hours or until clinically significant bleeding had stopped. Blood products transfused after CPB separation were based on a pre-defined protocol. Recommended volumes of each therapy were based on pre-defined formulae and a ROTEM analys |
| Post-operative 2 hr Fibrinogen mg/dL | 2 hour | Post-operative 2 hr Fibrinogen between the treatment and placebo group. A transfusion algorithm was developed based on three previous studies, modified for pediatrics. Clinically significant bleeding requiring treatment was defined as a rate \>10 cc kg-1 hr-1 calculated every 15 minutes while in the OR, measured by blood in the suction canister. In cases of continued bleeding following randomization to HFC or placebo, cryoprecipitate was considered for fibrinogen \<200 mg/dL or FIBTEM MCF \<7 mm. Thereafter, as per routine care, ROTEM analysis was performed at least every 30 minutes while in the OR, or sooner, at the discretion of the OR team. Once the patient left the OR, ROTEM was performed at least every 60 minutes for the first 6 hours or until clinically significant bleeding had stopped. Blood products transfused after CPB separation were based on a pre-defined protocol. Recommended volumes of each therapy were based on pre-defined formulae and a ROTEM analysis algorithm. |
| Postoperative Blood Loss After Surgery (Estimated Blood Loss (EBL)) | Within 24 hours of surgery | Primary outcome efficacy: Estimated blood loss (EBL); median; A transfusion algorithm was developed based on three previous studies, modified for pediatrics. Clinically significant bleeding requiring treatment was defined as a rate \>10 cc kg-1 hr-1 calculated every 15 minutes while in the OR, measured by blood in the suction canister. In cases of continued bleeding following randomization to HFC or placebo, cryoprecipitate was considered for fibrinogen \<200 mg/dL or FIBTEM MCF \<7 mm. Thereafter, as per routine care, ROTEM analysis was performed at least every 30 minutes while in the OR, or sooner, at the discretion of the OR team. Once the patient left the OR, ROTEM was performed at least every 60 minutes for the first 6 hours or until clinically significant bleeding had stopped. Blood products transfused after CPB separation were based on a pre-defined protocol. Recommended volumes of each therapy were based on pre-defined formulae and a ROTEM analysis algorithm. |
| Post-operative 2 hr Hemoglobin (Hg) mg/dL Measure | 2 hour | Post-operative 2 hr hemoglobin (Hg) between the treatment and placebo group. A transfusion algorithm was developed based on three previous studies, modified for pediatrics. Clinically significant bleeding requiring treatment was defined as a rate \>10 cc kg-1 hr-1 calculated every 15 minutes while in the OR, measured by blood in the suction canister. In cases of continued bleeding following randomization to HFC or placebo, cryoprecipitate was considered for fibrinogen \<200 mg/dL or FIBTEM MCF \<7 mm. Thereafter, as per routine care, ROTEM analysis was performed at least every 30 minutes while in the OR, or sooner, at the discretion of the OR team. Once the patient left the OR, ROTEM was performed at least every 60 minutes for the first 6 hours or until clinically significant bleeding had stopped. Blood products transfused after CPB separation were based on a pre-defined protocol. Recommended volumes of each therapy were based on pre-defined formulae and a ROTEM analysis algorithm. |
| Post-operative 24-hr Hemoglobin (Hg) mg/dL | 24 hr | Post-operative 24-hr hemoglobin (Hg) between treatment and placebo. A transfusion algorithm was developed based on three previous studies, modified for pediatrics. Clinically significant bleeding requiring treatment was defined as a rate \>10 cc kg-1 hr-1 calculated every 15 minutes while in the OR, measured by blood in the suction canister. In cases of continued bleeding following randomization to HFC or placebo, cryoprecipitate was considered for fibrinogen \<200 mg/dL or FIBTEM MCF \<7 mm. Thereafter, as per routine care, ROTEM analysis was performed at least every 30 minutes while in the OR, or sooner, at the discretion of the OR team. Once the patient left the OR, ROTEM was performed at least every 60 minutes for the first 6 hours or until clinically significant bleeding had stopped. Blood products transfused after CPB separation were based on a pre-defined protocol. Recommended volumes of each therapy were based on pre-defined formulae and a ROTEM analysis algorithm. |
| Post-operative 2 hr Hematocrit (HCT) Measure | 2 hour | Post-operative 2 hr Hematocrit (HCT) between the treatment and placebo group. |
| Post-operative 24 hr Hematocrit (HCT) Measure | 24 hour | Post-operative 24 hr Hematocrit (HCT) between the treatment and placebo group |
| Post-operative 2 hr Platelets Count Test (PLT) 10K/uL | 2 hour | Post-operative 2 hr Platelets Count Test (PLT) between the treatment and placebo group. A transfusion algorithm was developed based on three previous studies, modified for pediatrics. Clinically significant bleeding requiring treatment was defined as a rate \>10 cc kg-1 hr-1 calculated every 15 minutes while in the OR, measured by blood in the suction canister. In cases of continued bleeding following randomization to HFC or placebo, cryoprecipitate was considered for fibrinogen \<200 mg/dL or FIBTEM MCF \<7 mm. Once the patient left the OR, ROTEM was performed at least every 60 minutes for the first 6 hours or until clinically significant bleeding had stopped. Blood products transfused after CPB separation were based on a pre-defined protocol. Recommended volumes of each therapy were based on pre-defined formulae and a ROTEM analysis algor |
| Post-operative 24 hr Platelets Count Test (PLT) 10K/uL | 24 hour | Post-operative 24 hr Platelets Count Test (PLT) between the treatment and placebo group. A transfusion algorithm was developed based on three previous studies, modified for pediatrics. Clinically significant bleeding requiring treatment was defined as a rate \>10 cc kg-1 hr-1 calculated every 15 minutes while in the OR, measured by blood in the suction canister. In cases of continued bleeding following randomization to HFC or placebo, cryoprecipitate was considered for fibrinogen \<200 mg/dL or FIBTEM MCF \<7 mm. Once the patient left the OR, ROTEM was performed at least every 60 minutes for the first 6 hours or until clinically significant bleeding had stopped. Blood products transfused after CPB separation were based on a pre-defined protocol. Recommended volumes of each therapy were based on pre-defined formulae and a ROTEM analysis algo |
| Post-operative 2 hr Prothrombin (PT) Seconds | 2 hour | Post-operative 2 hr Prothrombin (PT) between the treatment and placebo group. A transfusion algorithm was developed based on three previous studies, modified for pediatrics. Clinically significant bleeding requiring treatment was defined as a rate \>10 cc kg-1 hr-1 calculated every 15 minutes while in the OR, measured by blood in the suction canister. In cases of continued bleeding following randomization to HFC or placebo, cryoprecipitate was considered for fibrinogen \<200 mg/dL or FIBTEM MCF \<7 mm. Thereafter, as per routine care, ROTEM analysis was performed at least every 30 minutes while in the OR, or sooner, at the discretion of the OR team. Once the patient left the OR, ROTEM was performed at least every 60 minutes for the first 6 hours or until clinically significant bleeding had stopped. Blood products transfused after CPB separation were based on a pre-defined protocol. Recommended volumes of each therapy were based on pre-defined formulae and a ROTEM analysis algorithm. |
| Post-operative 24 hr Prothrombin (PT) Seconds | 24 hour | Post-operative 24 hr Prothrombin (PT) between the treatment and placebo group. A transfusion algorithm was developed based on three previous studies, modified for pediatrics. Clinically significant bleeding requiring treatment was defined as a rate \>10 cc kg-1 hr-1 calculated every 15 minutes while in the OR, measured by blood in the suction canister. In cases of continued bleeding following randomization to HFC or placebo, cryoprecipitate was considered for fibrinogen \<200 mg/dL or FIBTEM MCF \<7 mm. Thereafter, as per routine care, ROTEM analysis was performed at least every 30 minutes while in the OR, or sooner, at the discretion of the OR team. Once the patient left the OR, ROTEM was performed at least every 60 minutes for the first 6 hours or until clinically significant bleeding had stopped. Blood products transfused after CPB separation were based on a pre-defined protocol. Recommended volumes of each therapy were based on pre-defined formulae and a ROTEM analysis algorithm. |
| Post-operative 2 hr International Normalize Ratio (INR) | 2 hour | Post-operative 2 hr International Normalize Ratio (INR) between the treatment and placebo group |
| Post-operative 24 hr International Normalize Ratio (INR) | 24 hour | Post-operative 24 hr International Normalize Ratio (INR) between the treatment and placebo group. A transfusion algorithm was developed based on three previous studies, modified for pediatrics. Clinically significant bleeding requiring treatment was defined as a rate \>10 cc kg-1 hr-1 calculated every 15 minutes while in the OR, measured by blood in the suction canister. In cases of continued bleeding following randomization to HFC or placebo, cryoprecipitate was considered for fibrinogen \<200 mg/dL or FIBTEM MCF \<7 mm. Once the patient left the OR, ROTEM was performed at least every 60 minutes for the first 6 hours or until clinically significant bleeding had stopped. Blood products transfused after CPB separation were based on a pre-defined protocol. Recommended volumes of each therapy were based on pre-defined formulae and a ROTEM ana |
| Post-operative 2 hr Partial Thromboplastin Time (PTT) Seconds | 2 hour | Post-operative 2 hr Partial Thromboplastin Time (PTT) between the treatment and placebo group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Thrombus Adverse Events | within 24 hours of surgery | Patient who suffered from Thrombus events post-operatively. |
| Post-Operative Respiratory Failure Adverse Events | 24 hours after surgery | Patients who suffered from respiratory failure post operatively. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| RiaSTAP Group 1 will receive an infusion of RiaSTAP after termination of CPB at a dose of 70 mg/kg after randomization to this group.
RiaStAP: To decrease post-operative bleeding volume. | 15 |
| Saline Group 2 will receive a placebo consisting of Normal Saline 0.9% (NS) after randomization to this group.
Saline: Placebo consisting of normal saline 0.9% | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | RiaSTAP | Saline | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 15 Participants | 15 Participants | 30 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Black/African American | 3 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized Race Mixed Race | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Race White | 10 Participants | 13 Participants | 23 Participants |
| Region of Enrollment United States | 15 participants | 15 participants | 30 participants |
| Sex: Female, Male Female | 6 Participants | 7 Participants | 13 Participants |
| Sex: Female, Male Male | 9 Participants | 8 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 7 / 15 | 5 / 15 |
Outcome results
Primary
Post-operative 24 hr Fibrinogen mg/dL
Post-operative 24 hr Fibrinogen between the treatment and placebo group
Time frame: 24 hour
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RiaSTAP | Post-operative 24 hr Fibrinogen mg/dL | 416.5 mg/dL |
| Saline | Post-operative 24 hr Fibrinogen mg/dL | 403.0 mg/dL |
Primary
Post-operative 24 hr Hematocrit (HCT) Measure
Post-operative 24 hr Hematocrit (HCT) between the treatment and placebo group
Time frame: 24 hour
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RiaSTAP | Post-operative 24 hr Hematocrit (HCT) Measure | 38.9 percent |
| Saline | Post-operative 24 hr Hematocrit (HCT) Measure | 35.4 percent |
Primary
Post-operative 24-hr Hemoglobin (Hg) mg/dL
Post-operative 24-hr hemoglobin (Hg) between treatment and placebo. A transfusion algorithm was developed based on three previous studies, modified for pediatrics. Clinically significant bleeding requiring treatment was defined as a rate \>10 cc kg-1 hr-1 calculated every 15 minutes while in the OR, measured by blood in the suction canister. In cases of continued bleeding following randomization to HFC or placebo, cryoprecipitate was considered for fibrinogen \<200 mg/dL or FIBTEM MCF \<7 mm. Thereafter, as per routine care, ROTEM analysis was performed at least every 30 minutes while in the OR, or sooner, at the discretion of the OR team. Once the patient left the OR, ROTEM was performed at least every 60 minutes for the first 6 hours or until clinically significant bleeding had stopped. Blood products transfused after CPB separation were based on a pre-defined protocol. Recommended volumes of each therapy were based on pre-defined formulae and a ROTEM analysis algorithm.
Time frame: 24 hr
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RiaSTAP | Post-operative 24-hr Hemoglobin (Hg) mg/dL | 13.8 mg/dL |
| Saline | Post-operative 24-hr Hemoglobin (Hg) mg/dL | 12.4 mg/dL |
Primary
Post-operative 24 hr International Normalize Ratio (INR)
Post-operative 24 hr International Normalize Ratio (INR) between the treatment and placebo group. A transfusion algorithm was developed based on three previous studies, modified for pediatrics. Clinically significant bleeding requiring treatment was defined as a rate \>10 cc kg-1 hr-1 calculated every 15 minutes while in the OR, measured by blood in the suction canister. In cases of continued bleeding following randomization to HFC or placebo, cryoprecipitate was considered for fibrinogen \<200 mg/dL or FIBTEM MCF \<7 mm. Once the patient left the OR, ROTEM was performed at least every 60 minutes for the first 6 hours or until clinically significant bleeding had stopped. Blood products transfused after CPB separation were based on a pre-defined protocol. Recommended volumes of each therapy were based on pre-defined formulae and a ROTEM ana
Time frame: 24 hour
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RiaSTAP | Post-operative 24 hr International Normalize Ratio (INR) | 1.3 ratio |
| Saline | Post-operative 24 hr International Normalize Ratio (INR) | 1.3 ratio |
Primary
Post-operative 24 hr Partial Thromboplastin Time (PTT) Seconds
Post-operative 24 hr Partial Thromboplastin Time (PTT) between the treatment and placebo group. A transfusion algorithm was developed based on three previous studies, modified for pediatrics. Clinically significant bleeding requiring treatment was defined as a rate \>10 cc kg-1 hr-1 calculated every 15 minutes while in the OR, measured by blood in the suction canister. In cases of continued bleeding following randomization to HFC or placebo, cryoprecipitate was considered for fibrinogen \<200 mg/dL or FIBTEM MCF \<7 mm. Once the patient left the OR, ROTEM was performed at least every 60 minutes for the first 6 hours or until clinically significant bleeding had stopped. Blood products transfused after CPB separation were based on a pre-defined protocol. Recommended volumes of each therapy were based on pre-defined formulae and a ROTEM analys
Time frame: 24 hour
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RiaSTAP | Post-operative 24 hr Partial Thromboplastin Time (PTT) Seconds | 35.5 seconds |
| Saline | Post-operative 24 hr Partial Thromboplastin Time (PTT) Seconds | 31.5 seconds |
Primary
Post-operative 24 hr Platelets Count Test (PLT) 10K/uL
Post-operative 24 hr Platelets Count Test (PLT) between the treatment and placebo group. A transfusion algorithm was developed based on three previous studies, modified for pediatrics. Clinically significant bleeding requiring treatment was defined as a rate \>10 cc kg-1 hr-1 calculated every 15 minutes while in the OR, measured by blood in the suction canister. In cases of continued bleeding following randomization to HFC or placebo, cryoprecipitate was considered for fibrinogen \<200 mg/dL or FIBTEM MCF \<7 mm. Once the patient left the OR, ROTEM was performed at least every 60 minutes for the first 6 hours or until clinically significant bleeding had stopped. Blood products transfused after CPB separation were based on a pre-defined protocol. Recommended volumes of each therapy were based on pre-defined formulae and a ROTEM analysis algo
Time frame: 24 hour
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RiaSTAP | Post-operative 24 hr Platelets Count Test (PLT) 10K/uL | 249.0 10x10^3 platelets/uL |
| Saline | Post-operative 24 hr Platelets Count Test (PLT) 10K/uL | 247.0 10x10^3 platelets/uL |
Primary
Post-operative 24 hr Prothrombin (PT) Seconds
Post-operative 24 hr Prothrombin (PT) between the treatment and placebo group. A transfusion algorithm was developed based on three previous studies, modified for pediatrics. Clinically significant bleeding requiring treatment was defined as a rate \>10 cc kg-1 hr-1 calculated every 15 minutes while in the OR, measured by blood in the suction canister. In cases of continued bleeding following randomization to HFC or placebo, cryoprecipitate was considered for fibrinogen \<200 mg/dL or FIBTEM MCF \<7 mm. Thereafter, as per routine care, ROTEM analysis was performed at least every 30 minutes while in the OR, or sooner, at the discretion of the OR team. Once the patient left the OR, ROTEM was performed at least every 60 minutes for the first 6 hours or until clinically significant bleeding had stopped. Blood products transfused after CPB separation were based on a pre-defined protocol. Recommended volumes of each therapy were based on pre-defined formulae and a ROTEM analysis algorithm.
Time frame: 24 hour
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RiaSTAP | Post-operative 24 hr Prothrombin (PT) Seconds | 16.0 seconds |
| Saline | Post-operative 24 hr Prothrombin (PT) Seconds | 16.1 seconds |
Primary
Post-operative 2 hr Fibrinogen mg/dL
Post-operative 2 hr Fibrinogen between the treatment and placebo group. A transfusion algorithm was developed based on three previous studies, modified for pediatrics. Clinically significant bleeding requiring treatment was defined as a rate \>10 cc kg-1 hr-1 calculated every 15 minutes while in the OR, measured by blood in the suction canister. In cases of continued bleeding following randomization to HFC or placebo, cryoprecipitate was considered for fibrinogen \<200 mg/dL or FIBTEM MCF \<7 mm. Thereafter, as per routine care, ROTEM analysis was performed at least every 30 minutes while in the OR, or sooner, at the discretion of the OR team. Once the patient left the OR, ROTEM was performed at least every 60 minutes for the first 6 hours or until clinically significant bleeding had stopped. Blood products transfused after CPB separation were based on a pre-defined protocol. Recommended volumes of each therapy were based on pre-defined formulae and a ROTEM analysis algorithm.
Time frame: 2 hour
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RiaSTAP | Post-operative 2 hr Fibrinogen mg/dL | 258.0 mg/dL |
| Saline | Post-operative 2 hr Fibrinogen mg/dL | 330.0 mg/dL |
Primary
Post-operative 2 hr Hematocrit (HCT) Measure
Post-operative 2 hr Hematocrit (HCT) between the treatment and placebo group.
Time frame: 2 hour
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RiaSTAP | Post-operative 2 hr Hematocrit (HCT) Measure | 40.9 percent of hematocrit |
| Saline | Post-operative 2 hr Hematocrit (HCT) Measure | 35.9 percent of hematocrit |
Primary
Post-operative 2 hr Hemoglobin (Hg) mg/dL Measure
Post-operative 2 hr hemoglobin (Hg) between the treatment and placebo group. A transfusion algorithm was developed based on three previous studies, modified for pediatrics. Clinically significant bleeding requiring treatment was defined as a rate \>10 cc kg-1 hr-1 calculated every 15 minutes while in the OR, measured by blood in the suction canister. In cases of continued bleeding following randomization to HFC or placebo, cryoprecipitate was considered for fibrinogen \<200 mg/dL or FIBTEM MCF \<7 mm. Thereafter, as per routine care, ROTEM analysis was performed at least every 30 minutes while in the OR, or sooner, at the discretion of the OR team. Once the patient left the OR, ROTEM was performed at least every 60 minutes for the first 6 hours or until clinically significant bleeding had stopped. Blood products transfused after CPB separation were based on a pre-defined protocol. Recommended volumes of each therapy were based on pre-defined formulae and a ROTEM analysis algorithm.
Time frame: 2 hour
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RiaSTAP | Post-operative 2 hr Hemoglobin (Hg) mg/dL Measure | 13.6 mg/dL |
| Saline | Post-operative 2 hr Hemoglobin (Hg) mg/dL Measure | 12.5 mg/dL |
Primary
Post-operative 2 hr International Normalize Ratio (INR)
Post-operative 2 hr International Normalize Ratio (INR) between the treatment and placebo group
Time frame: 2 hour
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RiaSTAP | Post-operative 2 hr International Normalize Ratio (INR) | 1.4 ratio |
| Saline | Post-operative 2 hr International Normalize Ratio (INR) | 1.4 ratio |
Primary
Post-operative 2 hr Partial Thromboplastin Time (PTT) Seconds
Post-operative 2 hr Partial Thromboplastin Time (PTT) between the treatment and placebo group
Time frame: 2 hour
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RiaSTAP | Post-operative 2 hr Partial Thromboplastin Time (PTT) Seconds | 36.7 seconds |
| Saline | Post-operative 2 hr Partial Thromboplastin Time (PTT) Seconds | 35.2 seconds |
Primary
Post-operative 2 hr Platelets Count Test (PLT) 10K/uL
Post-operative 2 hr Platelets Count Test (PLT) between the treatment and placebo group. A transfusion algorithm was developed based on three previous studies, modified for pediatrics. Clinically significant bleeding requiring treatment was defined as a rate \>10 cc kg-1 hr-1 calculated every 15 minutes while in the OR, measured by blood in the suction canister. In cases of continued bleeding following randomization to HFC or placebo, cryoprecipitate was considered for fibrinogen \<200 mg/dL or FIBTEM MCF \<7 mm. Once the patient left the OR, ROTEM was performed at least every 60 minutes for the first 6 hours or until clinically significant bleeding had stopped. Blood products transfused after CPB separation were based on a pre-defined protocol. Recommended volumes of each therapy were based on pre-defined formulae and a ROTEM analysis algor
Time frame: 2 hour
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RiaSTAP | Post-operative 2 hr Platelets Count Test (PLT) 10K/uL | 282.0 10x10^3 platelets/uL |
| Saline | Post-operative 2 hr Platelets Count Test (PLT) 10K/uL | 224.0 10x10^3 platelets/uL |
Primary
Post-operative 2 hr Prothrombin (PT) Seconds
Post-operative 2 hr Prothrombin (PT) between the treatment and placebo group. A transfusion algorithm was developed based on three previous studies, modified for pediatrics. Clinically significant bleeding requiring treatment was defined as a rate \>10 cc kg-1 hr-1 calculated every 15 minutes while in the OR, measured by blood in the suction canister. In cases of continued bleeding following randomization to HFC or placebo, cryoprecipitate was considered for fibrinogen \<200 mg/dL or FIBTEM MCF \<7 mm. Thereafter, as per routine care, ROTEM analysis was performed at least every 30 minutes while in the OR, or sooner, at the discretion of the OR team. Once the patient left the OR, ROTEM was performed at least every 60 minutes for the first 6 hours or until clinically significant bleeding had stopped. Blood products transfused after CPB separation were based on a pre-defined protocol. Recommended volumes of each therapy were based on pre-defined formulae and a ROTEM analysis algorithm.
Time frame: 2 hour
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RiaSTAP | Post-operative 2 hr Prothrombin (PT) Seconds | 17.0 seconds |
| Saline | Post-operative 2 hr Prothrombin (PT) Seconds | 16.5 seconds |
Primary
Postoperative Blood Loss After Surgery (Estimated Blood Loss (EBL))
Primary outcome efficacy: Estimated blood loss (EBL); median; A transfusion algorithm was developed based on three previous studies, modified for pediatrics. Clinically significant bleeding requiring treatment was defined as a rate \>10 cc kg-1 hr-1 calculated every 15 minutes while in the OR, measured by blood in the suction canister. In cases of continued bleeding following randomization to HFC or placebo, cryoprecipitate was considered for fibrinogen \<200 mg/dL or FIBTEM MCF \<7 mm. Thereafter, as per routine care, ROTEM analysis was performed at least every 30 minutes while in the OR, or sooner, at the discretion of the OR team. Once the patient left the OR, ROTEM was performed at least every 60 minutes for the first 6 hours or until clinically significant bleeding had stopped. Blood products transfused after CPB separation were based on a pre-defined protocol. Recommended volumes of each therapy were based on pre-defined formulae and a ROTEM analysis algorithm.
Time frame: Within 24 hours of surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RiaSTAP | Postoperative Blood Loss After Surgery (Estimated Blood Loss (EBL)) | 35 cc/kg |
| Saline | Postoperative Blood Loss After Surgery (Estimated Blood Loss (EBL)) | 33 cc/kg |
Secondary
Post-Operative Respiratory Failure Adverse Events
Patients who suffered from respiratory failure post operatively.
Time frame: 24 hours after surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RiaSTAP | Post-Operative Respiratory Failure Adverse Events | 3 participants |
| Saline | Post-Operative Respiratory Failure Adverse Events | 3 participants |
Secondary
Post-operative Thrombus Adverse Events
Patient who suffered from Thrombus events post-operatively.
Time frame: within 24 hours of surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RiaSTAP | Post-operative Thrombus Adverse Events | 4 participants |
| Saline | Post-operative Thrombus Adverse Events | 2 participants |