NCT03645837

Brief Summary

The purpose of the study is to compare different short durations of radial clamp application following an angiogram via a trans-radial approach.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 24, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

May 4, 2020

Status Verified

February 1, 2019

Enrollment Period

8 months

First QC Date

August 22, 2018

Last Update Submit

April 30, 2020

Conditions

Cardiac Catheterization

Outcome Measures

Primary Outcomes (2)

  • Hematoma

    Hematoma larger than 5 cm

    1 hour

  • Radial artery occlusion

    Assessed by Doppler

    1 hour

Secondary Outcomes (1)

  • Bleeding - any

    1 hour

Other Outcomes (1)

  • Comparison to prior study results

    1 hour

Study Arms (3)

10 minutes

EXPERIMENTAL

Compression clamp release start after 10 minutes

Other: Compression clamp release

20 minutes

EXPERIMENTAL

Compression clamp release start after 20 minutes

Other: Compression clamp release

30 minutes

ACTIVE COMPARATOR

Compression clamp release start after 30 minutes

Other: Compression clamp release

Interventions

Compression clamp releaseOTHER

Standard compression clamp is used and will be released at different times according to randomization

10 minutes20 minutes30 minutes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnostic catheterization
  • F slender sheath
  • Normal ulno-palmar circulation

You may not qualify if:

  • Abnormal ulno-palmar circulation type D
  • Ad hoc percutaneous coronary intervention
  • Heparin or other anticoagulation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A5A5, Canada

Location

Related Publications (1)

  • Lavi S, Cheema A, Yadegari A, Israeli Z, Levi Y, Wall S, Alemayehu M, Parviz Y, Murariu BD, McPherson T, Syed J, Bagur R. Randomized Trial of Compression Duration After Transradial Cardiac Catheterization and Intervention. J Am Heart Assoc. 2017 Feb 3;6(2):e005029. doi: 10.1161/JAHA.116.005029.

    PMID: 28159821BACKGROUND

Study Officials

  • Shahar Lavi, MD

    London Health Sceinces Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2018

First Posted

August 24, 2018

Study Start

October 1, 2018

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

May 4, 2020

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)