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USF Hemostasis: USage of HemCon for Femoral Hemostasis After Percutaneous Procedures (USF-Hemostasis)

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ClinicalTrials.gov Identifier: NCT00716365
Recruitment Status : Completed
First Posted : July 16, 2008
Last Update Posted : August 16, 2011
Sponsor:
Information provided by:
Meir Medical Center

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.


Condition or disease Intervention/treatment Phase
Coronary Angiography Device: HemCon bandage Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 278 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: USF Hemostasis: USage of HemCon for Femoral Hemostasis After Percutaneous
Study Start Date : January 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : August 2011

Arm Intervention/treatment
Experimental: HemCon

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
Other Name: HemCon




Primary Outcome Measures :
  1. Primary efficacy endpoint will be time to hemostasis. [ Time Frame: 1 hour ]

Secondary Outcome Measures :
  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. [ Time Frame: 24 hours ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00716365


Locations
Israel
Meir Medical Center
Kfar-Saba, Israel, 44281
Sponsors and Collaborators
Meir Medical Center
Investigators
Principal Investigator: Morris Mosseri, MD Tel-Aviv University, Sackler School of Medicine