To evaluate effect of Axiostat® to stop bleeding in patients undergoing Angiography/Angioplasty.

Phase 4

Completed

• Conditions: Health Condition 1: null- Angioplasty

• Registration Number: CTRI/2016/07/007115
• Lead Sponsor: Axio Biosolutions Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-11-09
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Age greater than or equal to 18 years.

2. Patient and/or patientâ??s legal representative and/or

impartial witness has/have been informed of the nature of

the study and agrees to its provision and has provided written

informed consent as approved by the Ethics Committee of the

investigative site.

3. Iatrogenic Incision

4. Patient who want to undergo radial intervention.

5. All incision size must be less than 5cm.

Exclusion Criteria

1. Prior diagnosis of disease or medical condition affecting the

ability of blood to clot (e.g., hemophilia.).

2. Patients with known sensitivity to chitosan (shellfish)

used in this study.

3. Patients who, in the opinion of the Investigator, may not

complete the study for any reason, e.g. Patient requiring

Immediate suturing.

4. Patient is currently participating in an investigational drug

or dressing study that has not yet completed its primary endpoint interferes with procedure and assessments in this

trial.

5. Pregnant women.

6. Patients with hemorrhagic shock.

7. Patient having hemoglobin < 9 g/dl.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy: <br/ ><br>(1)Time to achieve hemostasis by observing the time at which blood oozing through or from periphery of the dressing stops. <br/ ><br>(2)Proportion of patients with hemostasis. <br/ ><br>(3)No.(Qty.)of Axiostat®required to achieve hemostasis <br/ ><br>Safety: <br/ ><br>(1)No. of patients with bleeding with Axiostat® <br/ ><br>(2)No. of patient with re-bleeding after removal of Axiostat® at 0 min, 30 min and 60 min.Timepoint: 60 mins

Secondary Outcome Measures

Name	Time	Method
(1)No. of patient with allergy i.e. skin irritation because of Axiostat® <br/ ><br>(2)Patients comfort level as assessed by verbal inquiry after completion of procedure. <br/ ><br>(2)Level of ease of use by verbal inquiry with product use Axiostat® <br/ ><br>(3)Observation of formation of Hematoma and/or any vascular complication after removal of Axiostat®Timepoint: 60 mins