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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04163471
Other study ID # 20181194
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 4, 2018
Est. completion date May 1, 2019

Study information

Verified date November 2019
Source Forge Medical
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

VasoStat vs. TR Band compression for Radial Artery Hemostasis Following Transradial Catheterization Without Prior Radial Artery Access


Description:

Patients will be enrolled if they are scheduled to undergo a coronary or peripheral catheterization procedure involving the placement of a sheath (plastic tube) in the radial artery near the participants wrist. The purpose of this research is to compare two devices which make bleeding stop after the participants procedure is finished and the plastic tube is removed from the radial artery in the wrist. The two devices are called the VasoStat and the TR Band. Both of these devices are called hemostasis devices, which means they stop bleeding (hemostasis). Both devices are approved by the Food and Drug Administration (FDA) and are used throughout hospitals in the United States. The investigators will compare blood flow to the hand, and survey patients as to how comfortable these devices are, while they are being used to stop bleeding after the catheterization procedure.

Patients will be randomized to one device or the other as part of the study.

The investigators will noninvasively measure the blood flow to the hand by placing a soft plastic probe on the tip of the thumb called a plethysmography probe. This measurement only takes a few seconds and is painless. The investigators will measure before, after application and after removal & before patients are discharged. Thirty days later, patients will return for another measurement and to examine the radial artery with an ultrasound probe.

40 patients will be enrolled. Statistical analysis: Based on prior studies, The investigators will assume that the VasoStat produces a 30% reduction in hand perfusion during normal clinical use. The investigators assume the TR Band produces a 70% reduction in hand perfusion during normal clinical use. Using a two-sample test of proportions, with a Type I error of 5%, a power of 80%, and an anticipated drop-out rate of 10%, The investigators will need to enroll 40 patients (20 patients in each arm of the study) (StatMate 2.0, GraphPad Software, San Diego, CA)


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date May 1, 2019
Est. primary completion date March 6, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

• no prior radial access

Exclusion Criteria:

- Patients receiving concurrent investigational medications

- Cellulitis overlying radial artery

- Oral anticoagulation

- Patients receiving glycoprotein IIb/IIIa inhibitors

- Dementia

- Prisoners

- Institutionalized individuals

- Allergy to medical adhesive

- Radial sheath > 6 French (ID)

Study Design


Intervention

Device:
Radial artery mechanical compression for hemostasis
Transradial hemostasis following arterial catheterization procedures

Locations

Country Name City State
United States Billings Clinic Heart and Vascular at Community Medical Center Missoula Montana

Sponsors (2)

Lead Sponsor Collaborator
Forge Medical Billings Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Adverse outcomes Hematoma, swelling, pain, paresthesia, arterial venous fistula, pseudoaneurysm, partial or total radial artery occlusion During index hospital visit and at 30 day follow-up
Primary Comparison of impact of two radial artery compression devices on hand perfusion measurements Changes in Hand perfusion will be quantified using a noninvasive pulse oximetry technique and a previously validated metric known as the Perfusion Index, which is the ratio of the pulsatile blood flow to the nonpulsatile or static blood in peripheral tissue. The Perfusion Index represents a noninvasive measure of hand perfusion that can be continuously and noninvasively obtained from a specialized pulse oximeter. Perfusion index measurements day 1: before radial artery puncture, during wrist compression, after removal of compression device. Final perfusion index at 30-day followup appointment.
Secondary Comparison of impact of two radial artery compression devices on hand perfusion prior to and during ulnar artery compression Changes in Hand perfusion will be quantified using a noninvasive pulse oximetry technique and a previously validated metric known as the Perfusion Index, which is the ratio of the pulsatile blood flow to the nonpulsatile or static blood in peripheral tissue. The Perfusion Index represents a noninvasive measure of hand perfusion that can be continuously and noninvasively obtained from a specialized pulse oximeter. Perfusion index measurements on day 1 with ulnar compression: will include before radial artery puncture, and during wrist compression after radial sheath removal.
Secondary Patient satisfaction during use of wrist compression device Survey of patient perception of wrist discomfort, hand numbness, pain, swelling and willingness to use again in the future During application of radial artery mechanical compression
Secondary Hand perfusion and radial artery patency after one month Changes in Hand perfusion will be quantified using a noninvasive pulse oximetry technique and a previously validated metric known as the Perfusion Index, which is the ratio of the pulsatile blood flow to the nonpulsatile or static blood in peripheral tissue. The Perfusion Index represents a noninvasive measure of hand perfusion that can be continuously and noninvasively obtained from a specialized pulse oximeter. Duplex ultrasound will be used to assess radial artery patency. 30 day follow-up after use of mechanical wrist compression following transradial access for arterial catheterization procedures
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