Clinical trial NCT00684047: Safety and Efficacy Study of Fibrin Sealant Grifols Evaluated as an Adjunct to Hemostasis
Official title: A Prospective, Single-blind, Randomized, Phase II/III Study to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) as an Adjunct to Hemostasis During Peripheral Vascular Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Target Bleeding Site During Peripheral Vascular Surgery
Keywords: Fibrin Sealant
Hemostasis
Peripheral Vascular Surgery
Lead sponsor: Grifols Biologicals, LLC
Sponsor class: INDUSTRY
First posted: 2008-05-26
Enrollment: 239
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and hemostasis effectiveness of human plasma-derived fibrin sealant Grifols (FS Grifols) in peripheral vascular surgery.

Detailed description: The trial consisted of 2 parts: a Preliminary Part (I) and a Primary Part (II). All subjects enrolled in Preliminary Part (I) were treated with FS Grifols. Subjects in Primary Part (II) were randomly allocated in a 2:1 ratio to treatment with FS Grifols or manual compression. The objectives of the study were to evaluate the hemostasis effectiveness of FS Grifols in peripheral vascular surgery and to assess clinical safety, viral safety, and immunogenicity.

Eligibility criteria: Inclusion Criteria:

* Are male or female
* Must be at least 3 years of age with no upper age limit (must be at least 18 years of age in Spain and United Kingdom)
* Require an elective (non-emergency), open (non-laparoscopic; non-endovascular) peripheral vascular surgical procedure
* Have hemoglobin ≥ 9.0 g/dL
* Have platelet count \> 70 x 10\^3/mm\^3
* Required one peripheral vascular procedure involving either an arterial patch angioplasty or an arterial anastomosis utilizing polytetrafluoroethylene or Dacron grafts, according to the Investigator's (the surgeon's) selection:

  1. Carotid endarterectomy requiring patch angioplasty
  2. Carotid-subclavian bypass grafting
  3. Axillo-femoral bypass grafting
  4. Abdominal aortic aneurysm resection and graft replacement
  5. Aorto-mesenteric bypass grafting
  6. Aorto-celiac bypass grafting
  7. Aorto-uni-iliac bypass grafting
  8. Aorto-bi-iliac bypass grafting
  9. Aorto-uni-femoral bypass grafting
  10. Aorto-bi-femoral bypass grafting
  11. Iliac aneurysm resection and graft replacement
  12. Femoral aneurysm resection and graft replacement
  13. Femoral-femoral bypass grafting
  14. Femoral-popliteal bypass grafting
  15. Renal arterial revascularization (bypass grafting)
  16. Renal arterial revascularization (endarterectomy with patch angioplasty)
  17. Popliteal artery revascularization (bypass grafting)
  18. Popliteal artery revascularization (endarterectomy with patch angioplasty)
  19. Femoral endarterectomy with patch angioplasty
  20. Ilio-femoral bypass grafting
* Intra-operative inclusion criterion:

  * A Target bleeding site (TBS)can be identified according to the Investigator's judgment, and the TBS has a mild or moderate arterial bleeding according to the Investigator's judgment

Exclusion Criteria:

* Weighed \< 20 kg
* Have a pre-operative (at Baseline Assessments) international normalized ratio ≥ 2.0
* Have a pre-operative (at Baseline Assessments) activated partial thromboplastin time ratio ≥ 1.5
* Have a pre-operative (at Baseline Assessments) serum creatinine \> 2 times the upper limit of the normal range
* Were undergoing a re-operative procedure on same arterial patch angioplasty or arterial anastomosis
* Have an infection in the anatomical surgical area
* Have a history of severe (e.g., anaphylactic) reactions to blood or any blood derived product
* Unwilling to receive blood products
* Have positive bleeding history
* Female who was pregnant or nursing
* Are known to abuse alcohol, opiates, psychotropic agents or other chemicals or drugs, or have done so within 12 months to the screening visit.
* Are currently participating in another investigational drug or device clinical study, or have participated within 3 months to the screening visit.
* Were previously included in this clinical trial (protocol number IG402)

Primary outcomes:
measure: The Primary Efficacy Endpoint is Time to Hemostasis.
timeFrame: The start of treatment application at the target bleeding site (TBS) to the achievement of hemostasis at that site or to the end of the 10-minute observational period when the hemostasis has not yet been achieved.
Secondary outcomes:
measure: Proportions of Subjects Achieving Hemostasis
timeFrame: 10 minutes from the start of treatment application at the target bleeding site
measure: Prevalence of Treatment Failures
timeFrame: 10 minutes from the start of treatment application at the target bleeding site
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: St. Boniface General Hospital
state: Manitoba
city: London
country: Canada
facility: Schulich School of Medicine, London Health Sciences Center
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital
state: Ontario
city: Montreal
country: Canada
facility: Royal Victoria Hospital
state: Quebec
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Getafe
country: Spain
facility: Hospital Universitario de Getafe
state: Madrid
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial
city: Barcelona
country: Spain
facility: Hospital de Sabadell
city: Palma de Mallorca
country: Spain
facility: Hospital Son Espases
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
city: Edgbaston
country: United Kingdom
facility: Queen Elizabeth Hospital Birmingham
state: Birmingham
city: Frimley
country: United Kingdom
facility: Frimley Park Hospital
state: Surrey
city: Doncaster
country: United Kingdom
facility: Doncaster Royal Infirmary Hospital
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
city: Hull
country: United Kingdom
facility: Hull Royal Infirmary
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
city: Newcastle upon Tyne
country: United Kingdom
facility: Freeman Hospital
city: Tooting
country: United Kingdom
facility: St. George's Hospital
Study officials:
affiliation: Independent
name: Louis Kozloff, MD
role: STUDY_DIRECTOR
References: