Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Efficacy of Fibrin Sealant Grifols as an Adjunct to Haemostasis During Surgery in Paediatric Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03461406
Recruitment Status : Recruiting
First Posted : March 12, 2018
Last Update Posted : June 2, 2020
Sponsor:
Collaborator:
Instituto Grifols, S.A.
Information provided by (Responsible Party):
Grifols Therapeutics LLC

Brief Summary:

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 or disease Intervention/treatment Phase
Excessive Bleeding During Surgery Biological: Fibrin Sealant Grifols Biological: EVICEL Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Active-Controlled, Single-blind, Parallel Group Clinical Trial to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) as an Adjunct to Haemostasis During Surgery in Paediatric Subjects
Actual Study Start Date : December 5, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
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 Name: 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)




Primary Outcome Measures :
  1. Percentage of Subjects Achieving Hemostasis Within 4 Minutes After Treatment Start (T4) [ Time Frame: From start of treatment until 4 minutes after treatment start ]
    Subjects achieving hemostasis at the target bleeding site within 4 minutes following the start of treatment without the occurrence of re-bleeding or reapplication of study treatment after T4 and until the completion of surgical closure.


Secondary Outcome Measures :
  1. Cumulative Proportion of Subjects Achieving Hemostasis at the Target Bleeding Site by 7 Minutes After Treatment Start (T7). [ Time Frame: From start of treatment to 7 minutes after start of treatment. ]
  2. Cumulative Proportion of Subjects Achieving Hemostasis at the Target Bleeding Site by 10 Minutes After Treatment Start (T10). [ Time Frame: From start of treatment to 10 minutes after start of treatment. ]
  3. Prevalence of Treatment Failures [ Time Frame: From start of treatment up to 10 minutes after start of treatment and until the time of completion of surgical closure. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03461406


Contacts
Layout table for location contacts
Contact: Jordi Navarro Puerto +34 93 571 2200 Jordi.Navarro@grifols.com

Locations
Show Show 33 study locations
Sponsors and Collaborators
Grifols Therapeutics LLC
Instituto Grifols, S.A.
Layout table for additonal information
Responsible Party: Grifols Therapeutics LLC
ClinicalTrials.gov Identifier: NCT03461406    
Other Study ID Numbers: IG1405
First Posted: March 12, 2018    Key Record Dates
Last Update Posted: June 2, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Hemorrhage
Pathologic Processes
Fibrin Tissue Adhesive
Hemostatics
Coagulants