Completed

NCT Number: NCT01754480

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

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.

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Key information

Conditions

Parenchymous Tissue Surgical Bleeding

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

602, Budapest, Hungary

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fibrin Sealant Grifols

Biological

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.

Surgicel®

Device

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

Other names: Fibrillar absorbable hemostat, Oxidized regenerated cellulose hemostat

Primary outcomes

Proportion of Subjects Achieving Hemostasis by Four Minutes After Treatment Start

Time frame: 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 outcomes

Proportion of Subjects Achieving Hemostasis by Three Minutes After Treatment Start

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Instituto Grifols, S.A.

Industry

Registry information

Official study title

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

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2015
First posted: Dec 21, 2012
Registry last updated: Feb 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.