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Completed

NCT Number: NCT02822599

Human Fibrinogen Concentrate in Pediatric Cardiac Surgery

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.

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Key information

Conditions

Hypofibrinogenemia Abnormalities, Multiple Afibrinogenemia Bleeding Disorders Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Bone Diseases Bone Diseases, Developmental Cardiovascular Abnormalities Cardiovascular Diseases Chromosome Disorders Coagulation Protein Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Dysostoses Genetic Diseases, Inborn Heart Defects, Congenital Heart Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Intellectual Disability Musculoskeletal Abnormalities Musculoskeletal Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Rubinstein-Taybi Syndrome Vascular Diseases

Age range

1 day–1 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Nickalus Children's Hospital f/k/a Miami Children's Hospital, Miami, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RiaSTAP

Drug

To decrease post-operative bleeding volume.

Other names: Fibrinogen Concentrate Human

Saline

Drug

Placebo consisting of normal saline 0.9%

Other names: Normal Saline 0.9%

Primary outcomes

  1. Postoperative Blood Loss After Surgery (Estimated Blood Loss (EBL))

    Time frame: 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.

  2. Post-operative 2 hr Hemoglobin (Hg) mg/dL Measure

    Time frame: 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.

  3. Post-operative 24-hr Hemoglobin (Hg) mg/dL

    Time frame: 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.

  4. Post-operative 2 hr Hematocrit (HCT) Measure

    Time frame: 2 hour

    Post-operative 2 hr Hematocrit (HCT) between the treatment and placebo group.

  5. Post-operative 24 hr Hematocrit (HCT) Measure

    Time frame: 24 hour

    Post-operative 24 hr Hematocrit (HCT) between the treatment and placebo group

  6. Post-operative 2 hr Platelets Count Test (PLT) 10K/uL

    Time frame: 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

  7. Post-operative 24 hr Platelets Count Test (PLT) 10K/uL

    Time frame: 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

  8. Post-operative 2 hr Prothrombin (PT) Seconds

    Time frame: 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.

  9. Post-operative 24 hr Prothrombin (PT) Seconds

    Time frame: 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.

  10. Post-operative 2 hr International Normalize Ratio (INR)

    Time frame: 2 hour

    Post-operative 2 hr International Normalize Ratio (INR) between the treatment and placebo group

  11. Post-operative 24 hr International Normalize Ratio (INR)

    Time frame: 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

  12. Post-operative 2 hr Partial Thromboplastin Time (PTT) Seconds

    Time frame: 2 hour

    Post-operative 2 hr Partial Thromboplastin Time (PTT) between the treatment and placebo group

  13. Post-operative 24 hr Partial Thromboplastin Time (PTT) Seconds

    Time frame: 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

  14. Post-operative 2 hr Fibrinogen mg/dL

    Time frame: 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.

  15. Post-operative 24 hr Fibrinogen mg/dL

    Time frame: 24 hour

    Post-operative 24 hr Fibrinogen between the treatment and placebo group

Secondary outcomes

  1. Post-Operative Respiratory Failure Adverse Events

    Time frame: 24 hours after surgery

    Patients who suffered from respiratory failure post operatively.

  2. Post-operative Thrombus Adverse Events

    Time frame: within 24 hours of surgery

    Patient who suffered from Thrombus events post-operatively.

Sponsors and collaborators

Lead sponsor

Nicklaus Children's Hospital f/k/a Miami Children's Hospital

Other

Registry information

Official study title

The Role of Human Fibrinogen Concentrate (RiaSTAP) in Decreasing Blood Loss and the Need for Component Blood Therapy in Infants Undergoing Cardiopulmonary Bypass.

Acronym: RiaSTAP

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Jul 4, 2016
Registry last updated
Sep 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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