Adults 1 Day to 1, any sex, with Hypofibrinogenemia or Afibrinogenemia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Postoperative Blood Loss After Surgery (Estimated Blood Loss (EBL))Primary· 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
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
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 O
Post-operative 24 hr Hematocrit (HCT) between the treatment and placebo group
Group
Value
95% CI
RiaSTAP
38.9
34.1 – 45.3
Saline
35.4
32.9 – 42.8
Post-operative 2 hr Platelets Count Test (PLT) 10K/uLPrimary· 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 th
Group
Value
95% CI
RiaSTAP
282.0
234.0 – 309.0
Saline
224.0
192.0 – 311.0
Post-operative 24 hr Platelets Count Test (PLT) 10K/uLPrimary· 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 t
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 whil
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 whi
Group
Value
95% CI
RiaSTAP
16.0
15.4 – 18.2
Saline
16.1
14.9 – 17.1
Post-operative 2 hr International Normalize Ratio (INR)Primary· 2 hour
Post-operative 2 hr International Normalize Ratio (INR) between the treatment and placebo group
Group
Value
95% CI
RiaSTAP
1.4
1.3 – 1.5
Saline
1.4
1.2 – 1.4
Post-operative 24 hr International Normalize Ratio (INR)Primary· 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 minu
Group
Value
95% CI
RiaSTAP
1.3
1.2 – 1.5
Saline
1.3
1.2 – 1.4
Post-operative 2 hr Partial Thromboplastin Time (PTT) SecondsPrimary· 2 hour
Post-operative 2 hr Partial Thromboplastin Time (PTT) between the treatment and placebo group
Group
Value
95% CI
RiaSTAP
36.7
33.7 – 41.1
Saline
35.2
32.1 – 36.6
Adverse events — posted to ClinicalTrials.gov
Time frame: 24 hours after surgery;.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06434389 — A Point-of-care Electrochemical-based Device for Rapid Detection of Fibrinogen on Type A Aortic Dissection Surgery
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Nicklaus Children's Hospital f/k/a Miami Children's Hospital
Last refreshed: 16 September 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02822599.