Safety and Efficacy Study of Fibrin Sealant Grifols Evaluated as an Adjunct to Hemostasis

NCT ID: NCT00684047

Last Updated: 2016-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 239 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2014-05-31

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.

Conditions

Target Bleeding Site During Peripheral Vascular Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

FS Grifols Preliminary Part (I)

Open label administration of FS Grifols to all subjects

Group Type: EXPERIMENTAL

FS Grifols

Intervention Type: BIOLOGICAL

Fibrin Sealant Grifols (FS Grifols). Preliminary Part (I)

FS Grifols Primary Part (II)

Single-blind, randomized (2:1)

Group Type: EXPERIMENTAL

FS Grifols

Intervention Type: BIOLOGICAL

Fibrin Sealant Grifols (FS Grifols). Primary Part (II)

Manual Compression Primary Part (II)

Single-blind, randomized (2:1)

Group Type: ACTIVE_COMPARATOR

Manual Compression

Intervention Type: PROCEDURE

Manual Compression. Primary Part (II)

Interventions

FS Grifols

Fibrin Sealant Grifols (FS Grifols). Preliminary Part (I)

Intervention Type: BIOLOGICAL

FS Grifols

Fibrin Sealant Grifols (FS Grifols). Primary Part (II)

Intervention Type: BIOLOGICAL

Manual Compression

Manual Compression. Primary Part (II)

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto Grifols, S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Louis Kozloff, MD

Role: STUDY_DIRECTOR

Independent

Locations

St. Boniface General Hospital

Winnipeg, Manitoba, Canada

Schulich School of Medicine, London Health Sciences Center

London, Ontario, Canada

Ottawa Hospital

Ottawa, Ontario, Canada

Royal Victoria Hospital

Montreal, Quebec, Canada

Jewish General Hospital

Montreal, Quebec, Canada

Hospital Universitario de Getafe

Getafe, Madrid, Spain

Hospital Clinic i Provincial

Barcelona, , Spain

Hospital de Sabadell

Barcelona, , Spain

Hospital Son Espases

Palma de Mallorca, , Spain

Clinica Universitaria de Navarra

Pamplona, , Spain

Hospital Universitario Marques de Valdecilla

Santander, , Spain

Queen Elizabeth Hospital Birmingham

Edgbaston, Birmingham, United Kingdom

Frimley Park Hospital

Frimley, Surrey, United Kingdom

Doncaster Royal Infirmary Hospital

Doncaster, , United Kingdom

Royal Infirmary of Edinburgh

Edinburgh, , 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, , United Kingdom

Countries

Canada; Spain; United Kingdom

References

Ma GW, Kucey A, Tyagi SC, Papia G, Kucey DS, Varcoe RL, Forbes T, Neville R, Dueck AD, Kayssi A. The role of sealants for achieving anastomotic hemostasis in vascular surgery. Cochrane Database Syst Rev. 2024 May 2;5(5):CD013421. doi: 10.1002/14651858.CD013421.pub2.

Reference Type: DERIVED

PMID: 38695613 (View on PubMed)

Other Identifiers

IG402

Identifier Type: -

Identifier Source: org_study_id