Oximetry Guided Versus Traditional Rapid Deflation Technique for Achieving Hemostasis After Radial Procedures

NCT03626129 | Completed

• 1 other identifier: 1-10-72-159-18
• Study Type: interventional
• Target: 3,600
• Locations: 1 country
• Sites: 1

Brief Summary

After performing a radial angiography/percutaneous coronary intervention (CAG/PCI), the sheath is removed and a compression device is used to achieve hemostasis. Recent studies have indicated that rapid deflation techniques resulting in early removal of the compression device is associated with a low incidence of radial artery occlusion (RAO). The purpose of the present study is to evaluate whether an even faster removal of the compression device can be achieved if using oximetry guided rapid deflation compared to traditional rapid deflation, and whether this is associated with a lower incidence of RAO.

Conditions

Radial Artery

Keywords

Haemostasis; Trans radial band; Coronary angiography; Radial artery occlusion; Percutaneous coronary intervention

Outcome Measures

Primary Outcomes (4)

• RAO (Reverse Barbeau type D) during index hospitalisation

  The reverse Barbeau involves compression of the ulnar artery and evaluation of the radial oximetric waveform. This documents the flow through the radial artery post-hemostasis, were a test result A is an open artery and D is an occluded artery.

  Day 1 (Evaluated at time of TR-band removal)

• Time from sheath removal to removal of the TR-band

  The time period will be recorded in the cath. lab. and in the ward.

  Day 1

• Proportion who have the TR-band removed within 90,120 and 180 minutes

  Calculated with STATA, statistical software

  Day 1

• RAO (Reverse Barbeau type D) at follow-up

  The reverse Barbeau involves compression of the ulnar artery and evaluation of the radial oximetric waveform. This documents the flow through the radial artery post-hemostasis, were a test result A is an open artery and D is an occluded artery.

  After 1 month

Secondary Outcomes (5)

• RAO or subocclusion during index hospitalisation

  Day 1 (Evaluated at time of TR-band removal)

• Hematoma > 2.5 cm

  Day 1 (Evaluated at time of discharge)

• Time from sheath removal to discharge

  Day 1

• Discomfort in the arm

  At 1 month and 3 months

• RAO or subocclusion at follow-up

  At 1 month

Study Arms (2)

Traditional rapid deflation

NO INTERVENTION

Group A: At time of sheath removal 15 ml. air is inflated in the TR-band. The sheath is removed. Air is deflated until bleeding, and 1-2 ml. air is then re-inflated to achieve hemostasis, and the volume air inflated is registered ("Initial inflated air volume"). Every 20 minutes 1/3 of the initial inflated air volume is deflated. If bleeding occurs then air is re-inflated until hemostasis and then additional 1-2 ml. air is inflated. This routine is repeated until hemostasis is achieved (TR-band fully deflated without bleeding).

Oximetry guided deflation

EXPERIMENTAL

Group B: Initial step with sheath removal as in group A. Before departure from the cath.lab. a "Patent hemostasis test" (see description in "Interventions" below) is performed. Further action as described in "Interventions" below.

Procedure: Oximetry guided deflation

Interventions

Oximetry guided deflation PROCEDURE

At the cath.lab. (Step 1) a hemostasis test is performed: oxymetry device on the thumb, compress a.ulnaris, evaluate if curve on device (="Patent hemostasis"). If patent no further action. If not patent, air is deflated until a.radialis is patent (curve on device and no bleeding). If bleeding occurs before patency then re-inflate 1-2 ml. air until hemostasis (="no patent hemostasis"). In patients with "Patent hemostasis" no action is taken in sixty minutes whereafter the TR-band is fully deflated (Step 2), and if bleeding then air is re-inflated until hemostasis and step 2 is repeated every 20 minutes until the TR-band is fully deflated with hemostasis. If "no patent hemostasis" at cath.lab. a hemostasis test is performed after 20 min. If "patent hemostasis" is achieved no action is taken in sixy minutes (as above). If still "not patent" then further action as in group A.

Oximetry guided deflation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are scheduled for radial angiography or angioplasty.
• Patients with normal flow in a.ulnaris before the procedure (Barbeau type A or B).
• Age \> 18 years.
• Patients able to cooperate and understand information given by the hospital staff.

You may not qualify if:

• Patients not able to give informed consent.

Sponsors & Collaborators

• Aarhus University Hospital Skejby: lead
• Terumo Corporation: collaborator

Study Sites (1)

Department of cardiology, Aarhus University Hospital in Skejby

Aarhus, 8200, Denmark

Location

MeSH Terms

Conditions

Arterial Occlusive Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, DmSc, PhD, Associate professor

Study Record Dates

• First Submitted: August 1, 2018
• First Posted: August 10, 2018
• Study Start: October 16, 2018
• Primary Completion: December 10, 2021
• Study Completion: December 10, 2021
• Last Updated: May 5, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)