Purpose

This is a prospective, randomized, active-controlled, single-blind, parallel group clinical trial to evaluate the safety and efficacy of FS Grifols as an adjunct to hemostasis during surgery in pediatric subjects. Pediatric subjects (<18 years of age) requiring an elective (non-emergent), open (non-laparoscopic), pelvic, abdominal, or thoracic (non-cardiac) surgical procedure, wherein a target bleeding site (TBS) is identified, and a topical hemostatic agent is indicated, will be eligible to participate in the clinical trial. The study treatments will be applied on the cut parenchymous surface of a solid organ (ie, liver) and in soft tissue (ie, fat, muscle, or connective tissue).

Condition

Eligibility

Eligible Ages
Under 17 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

Pre-operative:

1. Less than 18 years of age.

2. Requires an elective (non-emergent), open (non-laparoscopic), pelvic, abdominal, or thoracic (non-cardiac) surgical procedure.

3. Subject and/or subject's legal guardian is willing to give permission for the subject to participate in the clinical trial and provide written informed consent for the subject. In addition, assent must be obtained from pediatric subjects who possess the intellectual and emotional ability to comprehend the concepts involved in the clinical trial.

Intra-operative:

4. Presence of an appropriate (as defined in inclusion criterion 5) parenchymous or soft tissue TBS identified intra-operatively by the investigator (the surgeon).

5. TBS has Grade 1 (mild) or Grade 2 (moderate) bleeding intensity according to the investigator's (the surgeon's) judgment. The intensity of the bleeding at the TBS will be rated by the investigator using the 5-point validated bleeding severity scale.

Exclusion Criteria

Pre-operative:

1. Admitted for trauma surgery.

2. Unwilling to receive blood products.

3. Known history of severe (eg, anaphylactic) reaction to blood products.

4. Known history of intolerance to any of the components of the investigational product (IP).

5. Female subjects who are pregnant, breastfeeding or, if of child-bearing potential (ie, adolescent), unwilling to practice a highly effective method of contraception.

6. Previously enrolled in a clinical trial with FS Grifols.

7. Currently participating, or during the study is planned to participate, in any other investigational device or medicinal product study without prior and explicit approval from the sponsor.

Intra-operative:

8. An appropriate parenchymous or soft tissue TBS (as defined in exclusion criteria 9 and 10) cannot be identified intra-operatively by the investigator (the surgeon).

9. TBS has Grade 3 (severe) bleeding according to the investigator's (the surgeon's) judgment that cannot be controlled with conventional surgical techniques to Grade 1 or Grade 2 bleeding. The intensity of the bleeding at the TBS will be rated by the investigator using the 5-point validated bleeding severity scale.

10. TBS is in an actively infected surgical field.

11. Occurrence of major intra-operative complications that require resuscitation or deviation from the planned surgical procedure.

12. Application of any topical hemostatic agent on the resection surface of parenchyma or soft tissue prior to application of the IP.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Fibrin Sealant Grifols
human fibrinogen (component 1: 80 mg/mL solution) and human thrombin (component 2: 500 IU/mL solution)
  • Biological: Fibrin Sealant Grifols
    human fibrinogen (component 1: 80 mg/mL solution) and human thrombin (component 2: 500 IU/mL solution) solutions filled in syringes and assembled on a syringe holder
    Other names:
    • FS Grifols
Active Comparator
EVICEL
human fibrinogen (55-85 mg/mL) and human thrombin (800-1200 IU/mL)
  • Biological: EVICEL
    1 vial of Biological Active Component 2, a frozen, sterile solution consisting of a concentrate of human fibrinogen (55-85 mg/mL) and 1 vial of thrombin (800-1200 IU/mL)

Recruiting Locations

Memorial Hermann Memorial City
Houston, Texas 77024

More Details

Status
Recruiting
Sponsor
Grifols Therapeutics LLC

Study Contact

Jordi Navarro Puerto
+34 93 571 2200
Jordi.Navarro@grifols.com

Detailed Description

This is a prospective, randomized, active-controlled, single-blind, parallel group clinical trial to evaluate the safety and efficacy of FS Grifols as an adjunct to hemostasis during surgery. Approximately 172 pediatric subjects will be enrolled and will be randomly allocated in a 1:1 ratio into 1 of 2 treatment groups: FS Grifols or EVICEL. Enrollment will be monitored by surgery type to ensure at least 50% of the surgical procedures are hepatic.

A specific bleeding site will be defined as the TBS when it is determined by the investigator (the surgeon) that control of bleeding by conventional surgical techniques (including suture, ligature, and cautery) is ineffective or impractical and requires an adjunct treatment to achieve hemostasis.

When the TBS is identified, the investigator will record the precise anatomical location of the TBS, rate the intensity of the bleeding at the TBS (Grade 1-4 according to a 5-point validated bleeding severity scale), and record the size of the approximate bleeding surface, (small, medium, and large). For soft tissue surgery only, the investigator will also record the type of soft tissue (ie, fat, muscle, or connective tissue). In this clinical trial, only subjects with a TBS with bleeding of Grade 1 (mild) or Grade 2 (moderate) intensity will be enrolled.

This study includes a Screening Visit to determine subject eligibility, a Baseline Visit, the Surgical Procedure (Day 1), and Post-operative assessments at Days 1, 4, and 30. The total duration of a subject's participation in this study is expected to be no longer than 2 months from the Screening Visit to the Post-operative Day 30 Visit.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.