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Oximetry Guided Versus Traditional Rapid Deflation Technique for Achieving Hemostasis After Radial Procedures (ACCESS-III)

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ClinicalTrials.gov Identifier: NCT03626129
Recruitment Status : Recruiting
First Posted : August 10, 2018
Last Update Posted : January 10, 2019
Sponsor:
Collaborator:
Terumo Corporation
Information provided by (Responsible Party):
Christian Juhl Terkelsen, Aarhus University Hospital Skejby

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.


Condition or disease Intervention/treatment Phase
Radial Artery Procedure: Oximetry guided deflation Not Applicable

Detailed Description:

3600 patients are randomized 1:1 to a traditional rapid deflation technique (Group A) versus an oximetry guided rapid deflation technique (Group B).

Before randomisation between the two deflation techniques French size of the sheath is chosen. If the operator has a preference for the size of the sheath then this size is used (5F/6F, estimated N=1200). If the operator has no preference for the size of the sheath then patients are randomized between 5 and 6 French sheath (N=2400).

Randomization between traditional rapid deflation technique (Group A) versus oximetry guided rapid deflation technique (Group B) is then stratified according to French size of the sheath used (5 French, 6 French). Terumo Glidesheath Slender is routinely used in both arms.

Assuming that the incidence of RAO (Barbeau type D, see below) can be reduced from 1.5% to 0.5% a total of 1547 patients are needed in each group if using an alfa=0.05 and beta 0.80. Assuming that the incidence of RAO or subocclusion (Barbeau type C or D, see below) can be reduced from 4% to 2% a total of 1141 patients are needed in each group to document this difference if using an alfa=0.05 and beta 0.80. The investigators plan to randomize 1800 in each group comparing oximetry guided rapid deflation with traditional rapid deflation. Assuming that the time from sheath removal to transradial-band (TR-band) removal (hemostasis) is 125 minutes with the traditional rapid deflation technique, and 110 minutes with the oximetry guided deflation technique, and the standard deviation is 60 minutes, then a total number of 253 patients are needed in each group to document a possible difference.

Data are analyzed by the intention-to-treat principle.

4-5 centres are expected to include patients.

Oral and written informed consent is collected at the ward or in the Cath.lab. The informed consent is signed before intervention.

Included patient can withdraw their assignment from the study at any time without consequence


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Randomised Comparison of Oximetry Guided Deflation Versus Traditional Rapid Deflation When Removing the TR-band After Radial Angiography or Angioplasty The Access-III Study
Actual Study Start Date : October 16, 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Arm Intervention/treatment
No Intervention: Traditional rapid deflation
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).
Experimental: Oximetry guided deflation
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
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.




Primary Outcome Measures :
  1. RAO (Reverse Barbeau type D) during index hospitalisation [ Time Frame: Day 1 (Evaluated at time of TR-band removal) ]
    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.

  2. Time from sheath removal to removal of the TR-band [ Time Frame: Day 1 ]
    The time period will be recorded in the cath. lab. and in the ward.

  3. Proportion who have the TR-band removed within 90,120 and 180 minutes [ Time Frame: Day 1 ]
    Calculated with STATA, statistical software

  4. RAO (Reverse Barbeau type D) at follow-up [ Time Frame: After 1 month ]
    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.


Secondary Outcome Measures :
  1. RAO or subocclusion during index hospitalisation [ Time Frame: Day 1 (Evaluated at time of TR-band removal) ]
    Evaluated by reverse Barbeau Test (type C+D) were a test result A is an open artery and D is a occluded artery and hence B + C are a subocclusion.

  2. Hematoma > 2.5 cm [ Time Frame: Day 1 (Evaluated at time of discharge) ]
    Development of hematoma is monitored at the ward at time of discharge.

  3. Time from sheath removal to discharge [ Time Frame: Day 1 ]
    The discharge time is recorded in the patient file

  4. Discomfort in the arm [ Time Frame: At 1 month and 3 months ]
    The pain numeric rating scale (NRS), on which patients rate their current pain intensity from 0 ("no pain") to 10 ("worst possible pain")

  5. RAO or subocclusion at follow-up [ Time Frame: At 1 month ]
    Evaluated by reverse Barbeau Test (type C+D) were a test result A is an open artery and D is a occluded artery and hence B + C are a subocclusion.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients not able to give informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03626129


Contacts
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Contact: Christian JTerkelsen, MD, DmSc, 78452017 chriterk@rm.dk

Locations
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Denmark
Department of cardiology, Aarhus University Hospital in Skejby Recruiting
Aarhus, Denmark, 8200
Contact: Christian J Terkelsen, MD, DmSc    78452017    chriterk@rm.dk   
Principal Investigator: Christian J Terkelsen, MD,PhD         
Sponsors and Collaborators
Aarhus University Hospital Skejby
Terumo Corporation

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Responsible Party: Christian Juhl Terkelsen, MD, DmSc, PhD, Associate professor, Aarhus University Hospital Skejby
ClinicalTrials.gov Identifier: NCT03626129     History of Changes
Other Study ID Numbers: 1-10-72-159-18
First Posted: August 10, 2018    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Christian Juhl Terkelsen, Aarhus University Hospital Skejby:
Haemostasis
Trans radial band
Coronary angiography
Radial artery occlusion
Percutaneous coronary intervention

Additional relevant MeSH terms:
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Hemostatics
Coagulants