Trial to Evaluate the Hemostatic Effect of Lyostypt® Versus Surgicel® in Arterial Bypass Anastomosis

NCT00837954 | Completed Phase 4

• 1 other identifier: AAG-G-H-0803
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this trial is to demonstrate that the bleeding time of suture holes after construction of arterial bypass anastomosis is shorter after treatment with Lyostypt® than with Surgicel®

Conditions

Peripheral Vascular Diseases; Hemostasis

Keywords

PTFE Graft; Suture Hole Bleeding; Hemostasis

Outcome Measures

Primary Outcomes (1)

• Time to hemostasis

  Minutes

Secondary Outcomes (3)

• Number of Complications

  30 days after surgery

• Postoperative Mortality

  30 days after surgery

• Efficacy Rating of Study Device evaluated by Surgeon

  intraoperatively

Study Arms (4)

1

ACTIVE COMPARATOR

distal Anastomosis Lyostypt®, proximal Anastomosis Surgicel®

Device: Lyostypt® AND Surgicel®

2

ACTIVE COMPARATOR

distal Anastomosis Surgicel®, proximal Anastomosis Lyostypt®

Device: Lyostypt® AND Surgicel®

3

ACTIVE COMPARATOR

distal and proximal Anastomosis Lyostypt®

Device: Lyostypt®

4

ACTIVE COMPARATOR

distal and proximal Anastomosis Surgicel®

Procedure: Surgicel®

Interventions

Lyostypt® AND Surgicel® DEVICE

The investigational products are the hemostats Lyostypt® and Surgicel® (=Tabotamp® ). Lyostypt® will be provided in the size 5cm x 8cm, Surgicel® will be provided in the size 5cm x 7,5cm. The devices will be cut into half. Lyostypt® is an absorbable wet-stable collagen compress made of collagen fibrils of bovine origin. Collagen leads to thrombocyte adhesion and to activation of coagulation factor XII. Surgicel® absorbable Haemostat is a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. After Surgicel® has been saturated with blood, it swells into a brownish or black gelatinous mass which aids in the formation of a clot, thereby serving as a haemostatic adjunct in the control of local haemorrhage.

Also known as: Lyostypt®, Surgicel®

1; 2

Lyostypt® DEVICE

The investigational product is the hemostat Lyostypt®. Lyostypt® will be provided in the size 5cm x 8cm. The devices will be cut into half. Lyostypt® is an absorbable wet-stable collagen compress made of collagen fibrils of bovine origin. Collagen leads to thrombocyte adhesion and to activation of coagulation factor XII.

3

Surgicel® PROCEDURE

The investigational product is the hemostat Surgicel® (=Tabotamp® ). Surgicel® will be provided in the size 5cm x 7,5cm. The devices will be cut into half. Surgicel® absorbable Haemostat is a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. After Surgicel® has been saturated with blood, it swells into a brownish or black gelatinous mass which aids in the formation of a clot, thereby serving as a haemostatic adjunct in the control of local haemorrhage.

4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with an indication for a peripheral vascular reconstruction due to peripheral vascular disease (PVD) including femoro-femoral, femoro-popliteal and femoro-crural reconstructions or the need of a crossover including femoro-femoral or ilaco-femoro reconstruction.
• suture hole bleeding of peripheral arterial bypass anastomosis using PTFE graft prosthesis
• Written informed consent

You may not qualify if:

• Emergency surgery
• Patients with coagulopathy or uremia
• Reoperation within one month at the same location
• Pregnant and Breastfeeding Women
• Known or suspected allergies or hypersensitivity to any of the used devices (e.g. to material of bovine origin)
• Severe comorbidity (ASA ≥ 4)
• Life expectancy less than 12 months
• Current immunosuppressive therapy (more than 40 mg of corticoid per day or ezathioprin)
• Chemotherapy within last 4 weeks
• Radiotherapy on the treated region within the last 2 months
• Severe psychiatric or neurologic diseases
• Lack of compliance

Sponsors & Collaborators

• Aesculap AG: lead

Study Sites (1)

Klinikum Hanau GmbH, Gefaesschirurgie

Hanau, Hesse, 63450, Germany

Location

Related Publications (28)

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  BACKGROUND

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• Ballotta E, Renon L, Toffano M, Da Giau G. Prospective randomized study on bilateral above-knee femoropopliteal revascularization: Polytetrafluoroethylene graft versus reversed saphenous vein. J Vasc Surg. 2003 Nov;38(5):1051-5. doi: 10.1016/s0741-5214(03)00608-6.

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• Qerimi B, Baumann P, Husing J, Knaebel HP, Schumacher H. Collagen hemostat significantly reduces time to hemostasis compared with cellulose: COBBANA, a single-center, randomized trial. Am J Surg. 2013 Jun;205(6):636-41. doi: 10.1016/j.amjsurg.2012.05.033. Epub 2013 Jan 17.

  PMID: 23332688 RESULT

• Baumann P, Schumacher H, Husing J, Luntz S, Knaebel HP. A randomized, controlled, prospective trial to evaluate the haemostatic effect of Lyostypt versus Surgicel in arterial bypass anastomosis: "COBBANA" trial. Trials. 2009 Sep 29;10:91. doi: 10.1186/1745-6215-10-91.

  PMID: 19788736 RESULT

MeSH Terms

Conditions

Peripheral Vascular Diseases

Interventions

Surgicel

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Hardy Schumacher, Prof. Dr.

  Klinikum Hanau GmbH

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2009
• First Posted: February 6, 2009
• Study Start: February 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: April 1, 2010
• Last Updated: May 28, 2015

Record last verified: 2015-05

Locations

DE (1)