Comparison of 2 Hemostasis Techniques After Transradial C... | NCT02873871

Studies
Comparison of 2 Hemostasis Techniques After Transradial Coronary

NCT02873871

Sponsor

Hospital de Clinicas de Porto Alegre

Status

Completed

Last Update Posted

Aug 12, 2020Actual

Enrollment

600Actual

Phase

Not Applicable

Conditions

Coronary Artery Disease With Myocardial Infarction

Interventions

Standardized compressive dressing
Hemostasis with TerumoBand®

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2015Actual

Primary Completion Date

Dec 2017Actual

Completion Date

Dec 2017Actual

First Submitted Date

Apr 10, 2016

First Submission Date that Met QC Criteria

Aug 16, 2016

First Posted Date

Aug 22, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 10, 2020

Last Update Posted Date

Aug 12, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Randomized clinical trial to compare radial artery patency after transradial coronary catheterization using 2 different hemostasis techniques. Patients submitted to diagnostic or therapeutic coronary catheterization will be prospectively enrolled in this single-center trial and will be randomized to radial hemostasis with TerumoBand® or a standardized compressive dressing with gauze and elastic bandage.

Detailed Description

Interventions: Radial hemostasis with TerumoBand® and Radial hemostasis with a standardized compressive dressing

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

600Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control group	Other	Standardized compressive dressing	Device: Standardized compressive dressing
Intervention group	Experimental	Hemostasis with TerumoBand®	Device: Hemostasis with TerumoBand®

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Standardized compressive dressing	Device	Standardized compressive dressing	Control group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Radial artery occlusion evaluated using Barbeau's test	test immediately after hemostasis compression device withdrawal	up to 3 hours

Secondary Outcomes

Measure	Description	Time Frame
Vascular complications	Clinical assesment	up to 3 hours
Radial access site pain	standardized scale	up to 3 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients submitted to elective or urgent coronary catheterization who presented with a A, B or C curve on oximetry test before the procedure

Exclusion Criteria:

Inability to understand the study and sign the informed consent form

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eneida Rejane Rabelo da Silva, RN, MSc, ScD	Hospital de Clinicas de Porto Alegre	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universidade Federal do Rio Grande do Sul - Post Graduated Program		Porto Alegre	Rio Grande do Sul	90035003	Brazil

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
C564258	Coronary Artery Disease, Autosomal Dominant, 1

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided