Target Bleeding Site During Peripheral Vascular Surgery Clinical Trial
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
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.
| Status | Completed |
| Enrollment | 239 |
| Est. completion date | May 2014 |
| Est. primary completion date | March 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 3 Years and older |
| Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | Schulich School of Medicine, London Health Sciences Center | London | Ontario |
| Canada | Jewish General Hospital | Montreal | Quebec |
| Canada | Royal Victoria Hospital | Montreal | Quebec |
| Canada | Ottawa Hospital | Ottawa | Ontario |
| Canada | St. Boniface General Hospital | Winnipeg | Manitoba |
| Spain | Hospital Clinic i Provincial | Barcelona | |
| Spain | Hospital de Sabadell | Barcelona | |
| Spain | Hospital Universitario de Getafe | Getafe | Madrid |
| Spain | Hospital Son Espases | Palma de Mallorca | |
| Spain | Clinica Universitaria de Navarra | Pamplona | |
| Spain | Hospital Universitario Marques de Valdecilla | Santander | |
| United Kingdom | Doncaster Royal Infirmary Hospital | Doncaster | |
| United Kingdom | Queen Elizabeth Hospital Birmingham | Edgbaston | Birmingham |
| United Kingdom | Royal Infirmary of Edinburgh | Edinburgh | |
| United Kingdom | Frimley Park Hospital | Frimley | Surrey |
| United Kingdom | Hull Royal Infirmary | Hull | |
| United Kingdom | Leeds General Infirmary | Leeds | |
| United Kingdom | Freeman Hospital | Newcastle upon Tyne | |
| United Kingdom | St. George's Hospital | Tooting |
| Lead Sponsor | Collaborator |
|---|---|
| Instituto Grifols, S.A. |
Canada, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The Primary Efficacy Endpoint is Time to Hemostasis. | The primary efficacy endpoint of the study is time to hemostasis (TTH), measured in minutes from the start of treatment application (TStart) at the TBS to the achievement of hemostasis at that site or to the end of the 10-minute observational period if hemostasis has not yet been achieved. | 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. | No |
| Secondary | Proportions of Subjects Achieving Hemostasis | The cumulative proportions of subjects who achieved hemostasis during the 10- minute observation period in Primary Part (II) | 10 minutes from the start of treatment application at the target bleeding site | No |
| Secondary | Prevalence of Treatment Failures | The cumulative proportions of subjects who did not achieve hemostasis during the 10- minute observation period in Primary Part (II) | 10 minutes from the start of treatment application at the target bleeding site | No |