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Fibrin Sealant Grifols for Vascular Bleeding

Phase 3
Waitlist Available
Research Sponsored by Instituto Grifols, S.A.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start of treatment until 4 minutes after treatment start
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

The purpose of this study is to demonstrate that the application of Fibrin Sealant Grifols provides a measurable benefit when compared to hemostasis achieved through conventional surgical technique (suture) and by standard hemostatic action, such as mechanical pressure through manual compression. This study has a Preliminary Part (I) in which all subjects are treated with Fibrin Sealant Grifols and a Primary Part (II) in which subjects are randomized in a 2:1 ratio to either Fibrin Sealant Grifols or manual compression.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of treatment until 4 minutes after treatment start
This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of treatment until 4 minutes after treatment start for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of Subjects Achieving Hemostasis by Four Minutes After Treatment Start
Secondary study objectives
Cumulative Proportion of Subjects Having Achieved Hemostasis at the Target Bleeding Site by Specified Time Points
Prevalence of Treatment Failures
Hemostatic function

Side effects data

From 2022 Phase 3 trial • 186 Patients • NCT03461406
6%
Pyrexia
3%
Vomiting
3%
Anaemia
2%
Nausea
1%
Pulmonary hypertension
1%
Sepsis
1%
Acute Respiratory Failure
1%
Pancytopenia
1%
Respiratory syncytial virus infection
1%
Mechanical ventilation complication
1%
Acquired hydrocele
1%
Acidosis
1%
Ascites
1%
Constipation
1%
Pneumonia
1%
Postoperative abscess
1%
Ileus paralytic
1%
Respiratory tract infection
1%
Hypoalbuminaemia
1%
Hypokalaemia
1%
Post procedural haemorrhage
1%
Cardiac arrest
1%
Pulmonary embolism
1%
Haemoglobin decreased
1%
Bronchospasm
1%
Cough
1%
Generalised oedema
1%
Abdominal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
EVICEL
Fibrin Sealant Grifols

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Fibrin Sealant GrifolsExperimental Treatment1 Intervention
Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total).
Group II: Manual CompressionActive Control1 Intervention
Direct manual compression of target bleeding site with gauze/laparotomy pads.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fibrin
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Instituto Grifols, S.A.Lead Sponsor
29 Previous Clinical Trials
5,202 Total Patients Enrolled
~17 spots leftby Oct 2025
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