RACC: Steri-strips for Reducing Radial Artery Compression Duration

Sponsor

National Institute of Cardiovascular Diseases, Karachi (Other)

Overall Status

Completed

CT.gov ID

NCT04900987

Collaborator

(none)

204

Enrollment

Location

Arms

Actual Duration (Months)

22.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The duration of radial artery compression with the use of steri-strips may become much shorter than the duration of using the conventional pneumatic TR band alone for achieving hemostasis. Consequently, the frequency of radial artery occlusion (RAO) will be much lower and post procedure patency of radial artery will be higher along with significant alleviation of pain duration.

Steri-strips is a kind of sterile adhesive tape used to approximate the clean and superficial wound or surgical incision as an alternate of stitch. Its ability to keep the radial puncture site incision approximated will lead to lesser chances of platelet plug disruption or displacement at the entry site and will hasten the process of hemostasis. The use of steri-strips unlikely to have adverse consequences as it is going to be used as an assist to the usual conventional method. In a study conducted by Faravash et al. in 2016, showed significant reduction in the area of post-rhinoplasty ecchymosis in lower lid, malar and cheek soft tissues with use of steri-strips with no reported safety concerns.

Therefore, the aim of this study is to compare duration of radial artery compression by conventional method using the pneumatic TR band alone and with use of surgical steri-strips for achieving hemostasis with patency of radial artery after transradial coronary angiography along with reduction of pain duration due to arterial compression.

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome	Device: Steri-strips	N/A

Detailed Description

Study population: patients undergoing coronary angiography through transradial approach. Study groups: patients will be randomly assigned in a 1:1 manner to radial arterial compression with conventional pneumatic TR band alone and radial arterial compression with pneumatic TR band mechanical compression with use of clean sterile steri-strips.

Treatment group. Pneumatic TR band compression with use of steri-strips

Control group. Pneumatic TR band compression alone

Method of radial artery compression after sheath removal:

Conventional mechanical compression: Application of pneumatic TR band alone for 4 hours.

Mechanical compression with use of steri-strips: After putting adequate manual pressure proximal to radial puncture site, dry and sterile application of steri-strip followed by pneumatic TR band for 1 hour.

END POINTS:

Primary endpoint will be the time duration of achieving hemostasis with radial artery patency

Secondary endpoint will be Hematoma or Bleeding

Study Design

Study Type:

Interventional

Actual Enrollment :

204 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

patients will be randomly assigned in a 1:1 manner to radial arterial compression with conventional pneumatic TR band alone and radial arterial compression with pneumatic TR band mechanical compression with use of clean sterile steri-strips.patients will be randomly assigned in a 1:1 manner to radial arterial compression with conventional pneumatic TR band alone and radial arterial compression with pneumatic TR band mechanical compression with use of clean sterile steri-strips.

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Application of Steri-strips for Reducing the Duration of Post Procedure Radial Artery Compression Via Conventional Pneumatic Transradial Band: An Open-label Randomized Controlled Trial

Actual Study Start Date :

Apr 1, 2021

Actual Primary Completion Date :

Dec 31, 2021

Actual Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment group After putting adequate manual pressure proximal to radial puncture site, dry and sterile application of steri-strip followed by pneumatic TR band for 1 to 2 hour.	Device: Steri-strips Pneumatic TR band compression with use of steri-strips
No Intervention: Control group Application of pneumatic TR band alone for 4 hours as per usual practice

Arm

Intervention/Treatment

Experimental: Treatment group

After putting adequate manual pressure proximal to radial puncture site, dry and sterile application of steri-strip followed by pneumatic TR band for 1 to 2 hour.

Device: Steri-strips

Pneumatic TR band compression with use of steri-strips

No Intervention: Control group

Application of pneumatic TR band alone for 4 hours as per usual practice

Outcome Measures

Primary Outcome Measures

Mean of [Immediately after removal of TR band]
Time duration of achieving hemostasis
Number of Participants with [After 24 hour of removal of TR band]
Radial artery patency

Secondary Outcome Measures

Number of Participants with [Immediately after removal of TR band]
Hematoma
Number of Participants with [Immediately after removal of TR band]
Bleeding

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients undergoing coronary angiography through transradial approach
Either gender with age ≥18 years
Positive Barbeau test (type A to C)

Exclusion Criteria:

Patients refuse to give consent
Negative Barbeau test (type D)
Patients with bleeding diathesis or on oral anticoagulation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Institute of Cardiovascular Diseases	Karachi	Sindh	Pakistan

Sponsors and Collaborators

National Institute of Cardiovascular Diseases, Karachi

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kamran Ahmed Khan, Assistant Professor of Cardiology, National Institute of Cardiovascular Diseases, Karachi

ClinicalTrials.gov Identifier:

NCT04900987

Other Study ID Numbers:

ERC-29/2021

First Posted:

May 25, 2021

Last Update Posted:

Feb 16, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Kamran Ahmed Khan, Assistant Professor of Cardiology, National Institute of Cardiovascular Diseases, Karachi

Additional relevant MeSH terms:

Acute Coronary Syndrome

Study Results

No Results Posted as of Feb 16, 2022