Study to evaluate the safety and efficacy of Fibrin Sealant Grifols (FS Grifols) in Soft Tissue Surgery
- Conditions
- Treatment of haemorrhage resulting from soft tissue surgical procedureTherapeutic area: Body processes [G] - Physical Phenomena [G01]
- Registration Number
- EUCTR2013-005159-34-HU
- Lead Sponsor
- Instituto Grifols, S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 736
1.Sign the written informed consent form (ICF). For pediatric patients, a parent or legal guardian must sign ICF.
2.Are male or female.
3.No lower or upper age limit.
4.Must have hemoglobin (Hgb) = 8.0 g/dL at Baseline.
5.Require an elective (non-emergency), open (non-laparoscopic) surgical procedure involving soft (non-parenchymous) tissue:
-Where Target Bleeding Site (TBS) is identified on soft tissue during following urologic, gynecologic or general surgery procedures:
i.Simple or radical nephrectomies.
ii.Total adrenalectomies.
iii.Radical prostatectomies.
iv.Pyeloplasties.
v.Radical cystectomies.
vi.Simple or radical hysterectomies.
vii.Lymphadenectomies (in the retroperitoneal or pelvic region only).
viii.Retroperitoneal tumor resections.
ix.Mastopexies.
x.Abdominoplasties.
6.Intra-operative inclusion criterion: a TBS can be identified according to the investigator’s judgment, and
-The TBS has moderate bleeding according to the investigator’s judgment.
Are the trial subjects under 18? yes
Number of subjects for this age range: 90
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 322
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 324
1.Require thoracic, abdominal, retroperitoneal or pelvic surgery due to trauma.
2.Have an infection in the anatomic surgical area.
3.Have a history of severe (e.g. anaphylactic) reactions to blood or to any blood-derived (human or animal) product.
4.Have previous known sensitivity to any FS Grifols component or any Surgicel® component.
5.(This exclusion criterion is removed).
6.Are unlikely to adhere to the protocol requirements, or to be cooperative during the study conduct.
7.Are females who are pregnant or nursing a child at Baseline.
8.Are receiving an organ transplant during the same surgical procedure.
9.Are currently participating or have participated in another clinical study in the context of which have received an investigational drug or device within 3 months from the screening visit, or are scheduled to participate during the course of this study.
10.Have undergone a therapeutic surgical procedure within 30 days from the screening visit.
11.Were previously enrolled in clinical trials with FS Grifols.
12.Intra-operative exclusion criterion:
-A TBS cannot be identified according to the Investigator’s judgment.
-The TBS has a mild or severe bleeding according to the Investigator’s judgment.
-Occurrence of major intraoperative complications that require resuscitation or deviation from the planned surgical procedure.
-Application of any topical haemostatic material on the cut soft tissue surface identified as the TBS prior to application of the study treatment.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the safety and the hemostasis efficacy of human plasma-derived fibrin sealant Grifols (FS Grifols) in soft tissue surgery;Secondary Objective: Not applicable;Primary end point(s): Proportion of subjects achieving haemostasis at the TBS by four (4) minutes after the start of treatment application.;Timepoint(s) of evaluation of this end point: Four (4) minutes after the start of treatment application (T4).
- Secondary Outcome Measures
Name Time Method