NCT01564888

Brief Summary

Evaluating the effect of ulnar artery compression while pressing on radial artery to stop bleeding, in maintaining radial artery potency, after cardiac catheterization through the radial artery. We prospectively plan to compare 3000 patients referred for cardiac catheterization, randomized into two groups, one group receiving radial artery compression for stopping bleeding, in a standard fashion following best practices, and the other group receiving radial artery compression using standard best practices and ulnar artery compression. Radial artery status will be evaluated in 24 hours and 30 days of the procedure to evaluate its potency, using plethysmography.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
3,000

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2011

Longer than P75 for phase_4

Geographic Reach
2 countries

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 28, 2012

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

September 17, 2019

Status Verified

September 1, 2019

Enrollment Period

4.5 years

First QC Date

March 26, 2012

Last Update Submit

September 14, 2019

Conditions

Occlusion of Artery

Outcome Measures

Primary Outcomes (1)

  • 30 day radial artery occlusion

    Evaluation of radial artery patency using plethysmography

    30 days

Secondary Outcomes (1)

  • hand ischemia

    2 hours

Study Arms (2)

Patent hemostasis

PLACEBO COMPARATOR

Patent hemostasis is the technique for radial artery hemostasis after transradial catheterization, with proactive attempt to maintain radial artery hemostasis and radial artery patency.

Procedure: Ulnar artery compression

Ulnar artery compression

ACTIVE COMPARATOR

Ulnar artery compression will involve radial artery hemostasis using patent hemostasis technique and compression of ulnar artery to the point of occluding flow, in an attempt to augment radial artery flow.

Procedure: Ulnar artery compression

Interventions

Ulnar artery compressionPROCEDURE

Compression of ulnar artery for 2 hours with radial artery hemostasis

Patent hemostasisUlnar artery compression

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients referred for diagnostic cardiac catheterization.

You may not qualify if:

  • previous ipsilateral radial artery puncture, warfarin therapy, absence of intact palmar collateral circulation, scleroderma, ipsilateral radial artery surgery, lone upper extremity (contralateral upper extremity amputation), ipsilateral upper extremity chronic pain.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital and Faculty of Medicine

Pilsen, Czechia

Location

V.S. General hospital

Ahmedabad, Gujarat, 380006, India

Location

MeSH Terms

Conditions

Arterial Occlusive Diseases

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Samir B Pancholy, MD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2012

First Posted

March 28, 2012

Study Start

January 1, 2011

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

September 17, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)IN(1)