NCT00154141

Brief Summary

A comparison of a fibrin sealant versus manual compression in stopping surgical bleeding during vascular procedures.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2005

Shorter than P25 for phase_3

Geographic Reach
2 countries

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

July 13, 2006

Status Verified

July 1, 2006

First QC Date

September 7, 2005

Last Update Submit

July 11, 2006

Conditions

Peripheral Vascular Disease

Outcome Measures

Primary Outcomes (1)

  • Attainment of hemostasis at following randomization.

Secondary Outcomes (4)

  • Attainment of hemostasis following randomization.

  • Incidence of treatment failures

  • Incidence of potential bleeding-related complications

  • Adverse events

Interventions

Fibrin sealant (FS2)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female subjects, 18 years or older, requiring elective, primary or repeat vascular procedures with at least one end-to-side femoral or upper extremity vascular access arterial anastomosis (e.g. femoral-femoral, femoral-popliteal, femoral-tibial, ilio-femoral, aorto-bifemoral, abdominal aortic aneurysm, upper extremity vascular access for dialysis) using uncoated or heparin-coated PTFE grafts and polypropylene sutures (size 5-0 or 6-0) with a 1:1 needle-to-thread ratio.
  • Following initial arterial clamp release, the study surgeon determines that adjunctive measures are needed to obtain haemostasis at the SAS.
  • Subjects must be willing to and capable of participating in the study, and provided written informed consent.

You may not qualify if:

  • Subjects undergoing re-vascularisation using autologous conduits (e.g. saphenous vein) or prosthetic material other than uncoated or heparin-coated PTFE.
  • Subjects undergoing emergency surgery.
  • Subjects with any intra-operative findings that may preclude conduct of the study procedure.
  • Subjects with known intolerance to heparin, blood products or to one of the components of the study product.
  • Subjects unwilling to receive blood products.
  • Subjects with autoimmune immunodeficiency diseases (including known HIV).
  • Subjects who are known, current alcohol and / or drug abusers.
  • Subjects who have participated in another investigational drug or device research study within 30 days of enrolment.
  • Female subjects who are pregnant or nursing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Baptist Medical Center

Jacksonville, Florida, 32216, United States

Location

Memorial Hospital

Jacksonville, Florida, 32216, United States

Location

Jackson Memorial Hospital

Miami, Florida, 33103, United States

Location

Southern Illinois University School of Medicine

Springfield, Illinois, 62702, United States

Location

Iowa Heart Center

Des Moines, Iowa, 50314, United States

Location

Univ of Mass Medical Center

Worcester, Massachusetts, 01655, United States

Location

Hackensack Medical Center

Hackensack, New Jersey, 07601, United States

Location

Alband Medical Center

Albany, New York, 12208, United States

Location

Millarad Fillmore Hospital, SUNY

Buffalo, New York, 14209, United States

Location

Jobst Vascular Center

Toledo, Ohio, 43606, United States

Location

Vanderbilt Univ Medical Center

Nashville, Tennessee, 37232, United States

Location

UVA Health System

Charlottesville, Virginia, 22908, United States

Location

Vascular and Transplant Specialists

Norfolk, Virginia, 23503, United States

Location

Aberdeen Royal Infirmary

Aberdeen, AB25 2ZN, United Kingdom

Location

Birmingham Heartlands Hospital

Birmingham, B9 5SS, United Kingdom

Location

Royal Infirmary of Edinburgh

Edinburgh, EH16 4SA, United Kingdom

Location

Hull Royal Infirmary

Hull, HU3 2JZ, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 38695613DERIVED

  • Chalmers RT, Darling Iii RC, Wingard JT, Chetter I, Cutler B, Kern JA, Hart JC. Randomized clinical trial of tranexamic acid-free fibrin sealant during vascular surgical procedures. Br J Surg. 2010 Dec;97(12):1784-9. doi: 10.1002/bjs.7235. Epub 2010 Aug 20.

    PMID: 20730858DERIVED

MeSH Terms

Conditions

Peripheral Vascular Diseases

Interventions

Fibrin Tissue Adhesive

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

FibrinBlood ProteinsProteinsAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 12, 2005

Study Start

June 1, 2005

Study Completion

March 1, 2006

Last Updated

July 13, 2006

Record last verified: 2006-07

Locations

GB(4)US(13)