USF Hemostasis: USage of HemCon for Femoral Hemostasis After Percutaneous Procedures

NCT00716365 | Completed Phase 4

• 1 other identifier: 0152-07MMC
• Study Type: interventional
• Target: 278
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Angiography

Keywords

angiography; hemostasis; femoral artery; duplex

Outcome Measures

Primary Outcomes (1)

• Primary efficacy endpoint will be time to hemostasis.

  1 hour

Secondary Outcomes (1)

• 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.

  24 hours

Study Arms (1)

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

Interventions

HemCon bandage DEVICE

5 cm X 5 cm

Also known as: HemCon

HemCon

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Meir Medical Center: lead

Study Sites (1)

Meir Medical Center

Kfar Saba, 44281, Israel

Location

Related Publications (3)

• 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. doi: 10.1097/01.ta.0000199392.91772.44.

  PMID: 16531872 BACKGROUND

• 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. doi: 10.1097/00005373-200301000-00023.

  PMID: 12544915 BACKGROUND

• 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. doi: 10.1080/10903120701205893.

  PMID: 17454803 BACKGROUND

Study Officials

• Morris Mosseri, MD

  Tel-Aviv University, Sackler School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 22, 2008
• First Posted: July 16, 2008
• Study Start: January 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: August 1, 2011
• Last Updated: August 16, 2011

Record last verified: 2011-08

Locations

IL (1)