USF Hemostasis: USage of HemCon for Femoral Hemostasis After Percutaneous Procedures - Full Text View

Sponsored by:	Meir Medical Center
Information provided by:	Meir Medical Center
ClinicalTrials.gov Identifier:	NCT00716365

Purpose

USF Hemostasis - USage of HemCon for Femoral Hemostasis after Percutaneous Procedures. A Comparative Open Label Study The purpose of this trial is to test HemCon pad after diagnostic percutaneous coronary angiography as an adjunct to manual compression to better control vascular access site bleeding and reduce time-to-hemostasis.

We hypothesize that the use of HemCon bandage (containing a carbohydrate called chitosan, found in the shells of shrimp, lobster and beetles) will shorten the time needed to achieve hemostasis, time to patient's ambulation, and patient's satisfaction without increasing vascular complications.

278 patients undergoing diagnostic coronary angiography receiving 2500 u intravenous Heparin will be studied and randomized for manual homeostasis with either a HemCon or a regular pad. Primary efficacy endpoint will be time to hemostasis. Secondary endpoints will be safety (complication rate) and satisfaction of patients regarding time to sitting incline and time to ambulation. 25% of patients from each arm will be randomized for Duplex examination of the femoral artery at the access site.

Condition	Intervention	Phase
Coronary Angiography	Device: HemCon bandage	Phase IV

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	USF Hemostasis: USage of HemCon for Femoral Hemostasis After Percutaneous

Further study details as provided by Meir Medical Center:

Primary Outcome Measures:

Primary efficacy endpoint will be time to hemostasis. [ Time Frame: 1 hour ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

be safety (complication rate) and satisfaction of patients regarding time to sitting incline and time to ambulation. 25% of patients from each arm will be randomized for Duplex examination of the femoral artery at the access site. [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	278
Study Start Date:	January 2008
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
HemCon: Experimental The purpose of this trial is to test HemCon pad after diagnostic percutaneous coronary angiography as an adjunct to manual compression to better control vascular access site bleeding and reduce time-to-hemostasis. The HemCon bandage (containing a carbohydrate called chitosan, found in the shells of shrimp, lobster and beetles) will be used to shorten the time needed to achieve hemostasis, time to patient's ambulation, and patient's.	Device: HemCon bandage 5 cm X 5 cm

Arms

Assigned Interventions

HemCon: Experimental

The purpose of this trial is to test HemCon pad after diagnostic percutaneous coronary angiography as an adjunct to manual compression to better control vascular access site bleeding and reduce time-to-hemostasis.

The HemCon bandage (containing a carbohydrate called chitosan, found in the shells of shrimp, lobster and beetles) will be used to shorten the time needed to achieve hemostasis, time to patient's ambulation, and patient's.

Device: HemCon bandage

5 cm X 5 cm

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 18-80 years old
Signing an informed consent
Percutaneous coronary angiography with a 6 french sheath via the femoral artery
Post catheterization non-invasive systolic blood pressure 150 mm Hg

Exclusion criteria:

STEMI
Patients who received IIb-IIIa antagonists before or during angiography.
Patients who received more than 2500u IV Heparin or more than 0.5 mg/kg LMWH within 8 hours before the procedure.
Known bleeding tendency, disturbed clotting system or platelet function
Evidence of bleeding or hematoma at the access site prior to sheath removal.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00716365

Contacts

Contact: Morris Mosseri, MD	972-9-747-1587	morris.mosseri@clalit.org.il
Contact: Nili Erez	972-9-747-2900	erez.nili@clalit.org.il

Locations

Israel
Meir Medical Center	Recruiting
Kfar-Saba, Israel, 44281

Sponsors and Collaborators

Meir Medical Center

Investigators

Principal Investigator:

Morris Mosseri, MD

Tel-Aviv University, Sackler School of Medicine

More Information

Publications:

Wedmore I, McManus JG, Pusateri AE, Holcomb JB. A special report on the chitosan-based hemostatic dressing: experience in current combat operations. J Trauma. 2006 Mar;60(3):655-8.

Pusateri AE, McCarthy SJ, Gregory KW, Harris RA, Cardenas L, McManus AT, Goodwin CW Jr. Effect of a chitosan-based hemostatic dressing on blood loss and survival in a model of severe venous hemorrhage and hepatic injury in swine. J Trauma. 2003 Jan;54(1):177-82.

Gustafson SB, Fulkerson P, Bildfell R, Aguilera L, Hazzard TM. Chitosan dressing provides hemostasis in swine femoral arterial injury model. Prehosp Emerg Care. 2007 Apr-Jun;11(2):172-8.

Responsible Party:	Division of Cardiology, Meir Medical Center, Kfar-Saba, Israel ( Prof. Morris Mosseri )
Study ID Numbers:	0152-07MMC
Study First Received:	May 22, 2008
Last Updated:	August 5, 2008
ClinicalTrials.gov Identifier:	NCT00716365
Health Authority:	Israel: Ministry of Health

Keywords provided by Meir Medical Center:

angiography
hemostasis
femoral artery
duplex

ClinicalTrials.gov processed this record on January 16, 2009