Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) During Parenchymous Tissue Open Surgeries

A Prospective, Single-blind, Randomized, Phase III Study to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) as an Adjunct to Hemostasis During Parenchymous Tissue Open Surgeries

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01754480

Enrollment

325

Registered

2012-12-21

Start date

2013-03-31

Completion date

2015-12-31

Last updated

2017-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parenchymous Tissue Surgical Bleeding

Keywords

Fibrin Sealant, Parenchymous tissue open surgery, Hepatic Resection, Oxidized cellulose pads

Brief summary

This study is designed to assess the safety and efficacy of Fibrin Sealant Grifols in patients undergoing open surgical procedures where bleeding may be present on parenchymous tissue (e.g., solid abdominal organs such as the liver). The purpose of this study is to demonstrate that Fibrin Sealant Grifols is not inferior to commercially-available oxidized cellulose pads (Surgicel®) in providing benefit in the time to hemostasis (i.e, the stoppage of bleeding). This study has a Preliminary Part (I) for study teams to become familiar with the application of Fibrin Sealant Grifols and to assess safety and a Primary Part (II) to assess the safety and efficacy of Fibrin Sealant Grifols. In both parts of the study, patients will be randomized in a 1:1 ratio to either Fibrin Sealant Grifols or Surgicel.

Interventions

BIOLOGICALFibrin Sealant Grifols

Combination of 3 mL fibrinogen and 3 mL thrombin, in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to the target bleeding site.

DEVICESurgicel®

Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Hemoglobin (Hgb) ≥ 8.0 g/dL at Baseline (within 24 hours prior to surgical procedure). * Require elective (non-emergency), open (non-laparoscopic), hepatic resection (anatomic or non-anatomic resections of at least one anatomical hepatic segment, or equivalent tissue volume). * A target bleeding site can be identified. * Target bleeding site is identified on the cut raw liver surface (resection area). * Target bleeding site has moderate bleeding according to the Investigator's judgment.

Exclusion criteria

* Require hepatic resection due to trauma. * Infection in the anatomic surgical area. * History of severe (e.g. anaphylactic) reactions to blood or to any blood-derived product. * Previous known sensitivity to any Fibrin Sealant Grifols component or any Surgicel® component. * Females who are pregnant or nursing a child at Baseline (within 24 hours prior to surgical procedure). * Receiving an organ transplant during the same surgical procedure. * Undergone a therapeutic surgical procedure within 30 days from the screening visit. * A target bleeding site cannot be identified. * The target bleeding site has a mild or severe bleeding. * Occurrence of major intraoperative complications that require resuscitation or deviation from the planned surgical procedure. * Application of any topical haemostatic material on the resection surface of the liver prior to application of study treatment.

Design outcomes

Primary

Measure	Time frame	Description
Proportion of Subjects Achieving Hemostasis by Four Minutes After Treatment Start	From start of treatment until 4 minutes after treatment start	Subjects achieving hemostasis at the target bleeding site by 4 minutes following the start of treatment without the occurrence of re-bleeding until the completion of surgical closure.

Secondary

Measure	Time frame	Description
Proportion of Subjects Achieving Hemostasis by Three Minutes After Treatment Start	From start of treatment until 3 minutes after treatment start	Subjects achieving hemostasis at the target bleeding site by 3 minutes following the start of treatment without the occurrence of re-bleeding until the completion of surgical closure.
Time to Hemostasis	From start of treatment until 10 minutes after treatment start	Time in minutes for achievement of hemostasis at the target bleeding site measured from the start of treatment until 10 minutes after treatment start.
Cumulative Proportion of Subjects Having Achieved Hemostasis at the Target Bleeding Site by Specified Time Points	From start of treatment until 10 minutes after treatment start	Cumulative proportion of subjects having achieved hemostasis by each of the following time points: * At 2 minutes following start of study treatment * At 5 minutes following start of study treatment * At 7 minutes following start of study treatment * At 10 minutes following start of study treatment
Prevalence of Treatment Failures	From start of treatment until 10 minutes after treatment start	Protocol-defined bleeding at the target bleeding site after the start of treatment or the use of alternative hemostatic treatments (with exception of reversal of heparin) or maneuvers at the target bleeding site after the start of treatment.

Countries

Hungary, Russia, Serbia, United States

Participant flow

Participants by arm

Arm	Count
Fibrin Sealant Grifols Fibrin Sealant Grifols: Combination of 3 mL fibrinogen and 3 mL thrombin, in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to the target bleeding site.	163
Surgicel® Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.	162
Total	325

Baseline characteristics

Characteristic	Surgicel®	Fibrin Sealant Grifols	Total
Age, Continuous	57.04 years STANDARD_DEVIATION 15.194	58.82 years STANDARD_DEVIATION 13.753	57.93 years STANDARD_DEVIATION 14.494
Age, Customized <=11 years	1 participants	2 participants	3 participants
Age, Customized >=65 years	58 participants	61 participants	119 participants
Age, Customized Between 12 and 17 years	2 participants	0 participants	2 participants
Age, Customized Between 18 and 64 years	101 participants	100 participants	201 participants
Gender Female	77 Participants	78 Participants	155 Participants
Gender Male	85 Participants	85 Participants	170 Participants
Region of Enrollment Hungary	19 participants	19 participants	38 participants
Region of Enrollment Russian Federation	2 participants	3 participants	5 participants
Region of Enrollment Serbia	50 participants	53 participants	103 participants
Region of Enrollment United States	91 participants	88 participants	179 participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	131 / 163	136 / 162
serious Total, serious adverse events	30 / 163	23 / 162

Outcome results

Primary

Proportion of Subjects Achieving Hemostasis by Four Minutes After Treatment Start

Subjects achieving hemostasis at the target bleeding site by 4 minutes following the start of treatment without the occurrence of re-bleeding until the completion of surgical closure.

Time frame: From start of treatment until 4 minutes after treatment start