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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.
Full description
USF Hemostasis USage of HemCon for Femoral Hemostasis after Percutaneous Procedures A Comparative Open Label Study Introduction After completion of angiography performed via the femoral artery, hemostasis is achieved by applying local pressure either manually or by mechanical devices for 10-20 minutes. This is time consuming for the physician, uncomfortable for the patient and occasionally complicated with vascular events that increase morbidity and hospital duration and reduce patient satisfaction. Closure devices have been developed to shorten pressure time but they are costly.
The HemCon pad is composed of a bandage containing a carbohydrate called chitosan, found in the shells of shrimp, lobster and beetles. Its molecules are positively charged and attract the negatively charged blood cells and platelets, and thus promote clotting. Chitosan hemorrhage control dressings have been shown to be effective in animal models of severe hemorrhage (1-4). Bandage. U.S. military personnel in the Iraquean and Afghanistan conflicts have used the HemCon Bandage to successfully stop arterial hemorrhage not controlled by conventional bandages in more then 64 patients without adverse effects (3,5). The HemCon bandage is also an FDA-cleared hemostatic dressing suitable for use in hemodialysis access puncture (2).
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 will shorten the time needed to achieve hemostasis, time to patient's ambulation, and patient's satisfaction without increasing vascular complications.
Endpoints Primary endpoint
Patients 278 patients undergoing diagnostic coronary angiography receiving 2500 u intravenous Heparin will be studied and randomized as written hereinafter.
Inclusion Criteria:
Exclusion criteria:
Protocol
Heparin treatment:
All patients will receive IV 2500 u Heparin immediately after introducing the femoral sheath.
Procedure duration will be recorded in minutes.
A 1:1 randomization of HemCon and regular pad will be performed after completion of the procedure. Envelopes marked with consecutive numbers will contain a note written: "HemCon pad" or "Regular pad ". Notes content will be randomized by a computer program.
After the procedure is completed and a decision is taken to withdraw the sheath the next consecutive envelope will be opened to determine the sheath removal technique to be used.
Arterial sheath removal:
The femoral sheath will be removed at the patient's bed (and not on the angiography table). One ml of blood will be allowed to flow from the access site. A HemCon or a regular pad (according to randomization) will be applied manually with occlusive pressure for 5 minutes.
After 5 minutes the operator will release the pressure. If bleeding continues, application of local pressure will be resumed. After this stage, the operator is allowed to release the pressure after every 5 minutes or longer at the operator's discretion. The total numbers of pressure release and the total time to hemostasis will be recorded.
After achieving hemostasis a pressure bandage will be applied at the access site for 3 hours.
Bed rest:
Ambulation:
After bed rest, ambulation is allowed providing no confounding events such as blood pressure abnormalities and hematoma have developed.
In hospital follow-up:
Discharge:
The patient will be discharged at the operator's discretion. Complications or adverse events will be noted and recorded upon discharge.
• Out of hospital and patient's satisfaction follow up: One day after discharge the patient will be contacted by phone and asked for any procedural complications (groin pain, hematoma) that appeared after discharge. If needed, the patient will be invited to the hospital for further investigation.
During the phone call the patient will be asked of his / her satisfaction of the ambulation procedure at a scale of 1-10 (10 mostly satisfactory).
Statistics
The following data will be compared between the 2 groups using t-test:
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