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Coagulation Factor

Fibrinogen for Bleeding

Q: Has a study like this ever been conducted before?

At present, 8 studies for Fibrinogen are occurring across 12 cities and 10 nations. The first experiment of its kind began in 2018, sponsored by PRA Health Sciences; it had 200 individuals involved and achieved Phase 3 approval status. Since then, 82 more research initiatives have been launched into action.

Q: How many test subjects are taking part in this trial?

Affirmative. Clinicaltrials.gov data shows that this trial, originally posted on October 26th 2021, is currently recruiting participants. The study aims to enrol 30 individuals from a single site.

Q: Are any new enrollees being accepted for this research project?

Affirmative. Data hosted on clinicaltrials.gov demonstrates that this medical investigation, initially posted on October 26th 2021, is presently enrolling volunteers. 30 participants must be recruited from a single trial site.

Q: What are the potential adverse effects of utilizing Fibrinogen as a treatment?

Our assessment of Fibrinogen's safety is rated 3, due to the Phase 4 classification of this medication which denotes an approved status.

Q: How is Fibrinogen commonly employed to assist patients?

Fibrinogen is a useful intervention in various medical contexts, from controlling hemostasis to treating acute bleeding episodes and hemorrhage.

Phase 4

Waitlist Available

Led By Jacob Raphael, MD

Research Sponsored by University of Virginia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from admission to the icu postoperatively until postoperative day 90 or discharge from the hospital (whichever occurs earlier)

Awards & highlights

Study Summary

This trial will compare the use of fibrinogen concentrate to cryoprecipitate for the treatment of cardiopulmonary bypass-associated bleeding in pediatric cardiac patients.

Eligible Conditions

Bleeding
Huntington's Disease

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from admission to the icu postoperatively until postoperative day 90 or discharge from the hospital (whichever occurs earlier)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from admission to the icu postoperatively until postoperative day 90 or discharge from the hospital (whichever occurs earlier)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from admission to the icu postoperatively until postoperative day 90 or discharge from the hospital (whichever occurs earlier) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

A composite of the number of any allogeneic blood products (RBCs, plasma, platelets, cryoprecipitate) transfused from administration of the study medication until 48 hours after surgery

Secondary outcome measures

Comparison of additional number cryoprecipitate units transfused immediately after administration of the study medication and until postoperative day 7

Comparison of post CPB bleeding (in ml) between the study groups

Comparison of the number RBC units transfused immediately after administration of the study medication and until postoperative day 7

+12 more

Other outcome measures

Percent of patients requiring postoperative Extra Corporeal Membrane Oxygenation (ECMO) support

Side effects data

From 2019 Phase 3 trial • 62 Patients • NCT01623531

Postoperative Delirium

Death

Re-Operation

Incisional wound infection

Stroke

100%

80%

60%

40%

20%

Study treatment Arm

RiaSTAP

Intravenous Saline

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Fibrinogen ConcentrateExperimental Treatment1 Intervention

Fibrinogen Concentrate (dose: 70 mg/kg; intervention group). in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF < 10 mm on the FIBTEM assay of ROTEM).

Group II: CryoprecipitateActive Control1 Intervention

. Cryoprecipitate (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF < 10 mm on the FIBTEM assay of ROTEM).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fibrinogen human

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor

753 Previous Clinical Trials

1,245,001 Total Patients Enrolled

1 Trials studying Bleeding

1,182 Patients Enrolled for Bleeding

OctapharmaIndustry Sponsor

84 Previous Clinical Trials

7,828 Total Patients Enrolled

1 Trials studying Bleeding

200 Patients Enrolled for Bleeding

Jacob Raphael, MDPrincipal InvestigatorUVA Anesthesiology

2 Previous Clinical Trials

143 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has a study like this ever been conducted before?

"At present, 8 studies for Fibrinogen are occurring across 12 cities and 10 nations. The first experiment of its kind began in 2018, sponsored by PRA Health Sciences; it had 200 individuals involved and achieved Phase 3 approval status. Since then, 82 more research initiatives have been launched into action."

Answered by AI

How many test subjects are taking part in this trial?

"Affirmative. Clinicaltrials.gov data shows that this trial, originally posted on October 26th 2021, is currently recruiting participants. The study aims to enrol 30 individuals from a single site."

Answered by AI

Are any new enrollees being accepted for this research project?

"Affirmative. Data hosted on clinicaltrials.gov demonstrates that this medical investigation, initially posted on October 26th 2021, is presently enrolling volunteers. 30 participants must be recruited from a single trial site."

Answered by AI