A Phase 4 interventional study of RiaStAP and Saline in Hypofibrinogenemia, Afibrinogenemia and Bleeding Disorders, sponsored by Nicklaus Children's Hospital f/k/a Miami Children's Hospital. Completed at 2 sites in United States. Open to participants aged 1 Day to 1 Year. Per ClinicalTrials.gov, last updated 2021-09-16.
Sponsored by Nicklaus Children's Hospital f/k/a Miami Children's Hospital · Phase 4, Interventional, and Prevention
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.
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.
503 studies on the registry are indexed under Hemostatic Disorders; 71 are open to participants now.
This study's enrollment of 30 is below the median of 51 across 253 interventional studies indexed under Hemostatic Disorders.
Browse Hemostatic Disorders studies →Nicklaus Children's Hospital f/k/a Miami Children's Hospital is the lead sponsor of 12 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Group 1 will receive an infusion of RiaSTAP after termination of CPB at a dose of 70 mg/kg after randomization to this group.
Drug: RiaStAP
Group 2 will receive a placebo consisting of Normal Saline 0.9% (NS) after randomization to this group.
Drug: Saline
To decrease post-operative bleeding volume.
Also known as: Fibrinogen Concentrate Human
Placebo consisting of normal saline 0.9%
Also known as: Normal Saline 0.9%
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
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
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
Post-operative 2 hr Hematocrit (HCT) Measure
Post-operative 2 hr Hematocrit (HCT) between the treatment and placebo group.
Time frame: 2 hour
Post-operative 24 hr Hematocrit (HCT) Measure
Post-operative 24 hr Hematocrit (HCT) between the treatment and placebo group
Time frame: 24 hour
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
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
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
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
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
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
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
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
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
Post-operative 24 hr Fibrinogen mg/dL
Post-operative 24 hr Fibrinogen between the treatment and placebo group
Time frame: 24 hour
Post-Operative Respiratory Failure Adverse Events
Patients who suffered from respiratory failure post operatively.
Time frame: 24 hours after surgery
Post-operative Thrombus Adverse Events
Patient who suffered from Thrombus events post-operatively.
Time frame: within 24 hours of surgery
| Milestone | RiaSTAP | Saline |
|---|---|---|
| Started | 15 | 15 |
| Completed | 15 | 15 |
| Not completed | 0 | 0 |
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.
| cc/kg | RiaSTAP | Saline |
|---|---|---|
| Postoperative Blood Loss After Surgery (Estimated Blood Loss (EBL)) | 35 (21 to 61) | 33 (26 to 48) |
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.
| mg/dL | RiaSTAP | Saline |
|---|---|---|
| Post-operative 2 hr Hemoglobin (Hg) mg/dL Measure | 13.6 (11.0 to 15.2) | 12.5 (11.7 to 13.3) |
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.
| mg/dL | RiaSTAP | Saline |
|---|---|---|
| Post-operative 24-hr Hemoglobin (Hg) mg/dL | 13.8 (11.7 to 15.8) | 12.4 (11.0 to 14.7) |
Post-operative 2 hr Hematocrit (HCT) between the treatment and placebo group.
| percent of hematocrit | RiaSTAP | Saline |
|---|---|---|
| Post-operative 2 hr Hematocrit (HCT) Measure | 40.9 (32.7 to 43.5) | 35.9 (35.4 to 38.8) |
Post-operative 24 hr Hematocrit (HCT) between the treatment and placebo group
| percent | RiaSTAP | Saline |
|---|---|---|
| Post-operative 24 hr Hematocrit (HCT) Measure | 38.9 (34.1 to 45.3) | 35.4 (32.9 to 42.8) |
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
| 10x10^3 platelets/uL | RiaSTAP | Saline |
|---|---|---|
| Post-operative 2 hr Platelets Count Test (PLT) 10K/uL | 282.0 (234.0 to 309.0) | 224.0 (192.0 to 311.0) |
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
| 10x10^3 platelets/uL | RiaSTAP | Saline |
|---|---|---|
| Post-operative 24 hr Platelets Count Test (PLT) 10K/uL | 249.0 (197.0 to 297.0) | 247.0 (189.0 to 300.0) |
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.
| seconds | RiaSTAP | Saline |
|---|---|---|
| Post-operative 2 hr Prothrombin (PT) Seconds | 17.0 (16.7 to 18.5) | 16.5 (15.8 to 17.2) |
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.
| seconds | RiaSTAP | Saline |
|---|---|---|
| Post-operative 24 hr Prothrombin (PT) Seconds | 16.0 (15.4 to 18.2) | 16.1 (14.9 to 17.1) |
Post-operative 2 hr International Normalize Ratio (INR) between the treatment and placebo group
| ratio | RiaSTAP | Saline |
|---|---|---|
| Post-operative 2 hr International Normalize Ratio (INR) | 1.4 (1.3 to 1.5) | 1.4 (1.2 to 1.4) |
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
| ratio | RiaSTAP | Saline |
|---|---|---|
| Post-operative 24 hr International Normalize Ratio (INR) | 1.3 (1.2 to 1.5) | 1.3 (1.2 to 1.4) |
Post-operative 2 hr Partial Thromboplastin Time (PTT) between the treatment and placebo group
| seconds | RiaSTAP | Saline |
|---|---|---|
| Post-operative 2 hr Partial Thromboplastin Time (PTT) Seconds | 36.7 (33.7 to 41.1) | 35.2 (32.1 to 36.6) |
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
| seconds | RiaSTAP | Saline |
|---|---|---|
| Post-operative 24 hr Partial Thromboplastin Time (PTT) Seconds | 35.5 (34.1 to 38.6) | 31.5 (30.3 to 35.5) |
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.
| mg/dL | RiaSTAP | Saline |
|---|---|---|
| Post-operative 2 hr Fibrinogen mg/dL | 258.0 (238.0 to 338.0) | 330.0 (281.0 to 385.0) |
Post-operative 24 hr Fibrinogen between the treatment and placebo group
| mg/dL | RiaSTAP | Saline |
|---|---|---|
| Post-operative 24 hr Fibrinogen mg/dL | 416.5 (318.5 to 512.0) | 403.0 (324.0 to 465.0) |
Patients who suffered from respiratory failure post operatively.
| participants | RiaSTAP | Saline |
|---|---|---|
| Post-Operative Respiratory Failure Adverse Events | 3 | 3 |
Patient who suffered from Thrombus events post-operatively.
| participants | RiaSTAP | Saline |
|---|---|---|
| Post-operative Thrombus Adverse Events | 4 | 2 |
Collected over 24 hours after surgery;. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| RiaStap | 0/15 (0%) | 7/15 (46.7%) | — |
| Placebo | 0/15 (0%) | 5/15 (33.3%) | — |
| Event | RiaStap | Placebo |
|---|---|---|
| ThrombusCardiac disorders | 4/15 | 2/15 |
| Acute Respiratory FailureRespiratory, thoracic and mediastinal disorders | 3/15 | 3/15 |
Baseline is 15 in RiaSTAP and 15 in Saline solution.
| Age, Categorical(Participants) | RiaSTAP | Saline | Total |
|---|---|---|---|
| <=18 years | 15 | 15 | 30 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | RiaSTAP | Saline | Total |
|---|---|---|---|
| Female | 6 | 7 | 13 |
| Male | 9 | 8 | 17 |
| Race/Ethnicity, Customized(Participants) | RiaSTAP | Saline | Total |
|---|---|---|---|
| Race — Mixed Race | 2 | 0 | 2 |
| Race — Black/African American | 3 | 2 | 5 |
| Race — White | 10 | 13 | 23 |
| Region of Enrollment(participants) | RiaSTAP | Saline | Total |
|---|---|---|---|
| United States | 15 | 15 | 30 |
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Nicklaus Children's Hospital f/k/a Miami Children's Hospital