NCT01489917

Brief Summary

The Provisional Heparin TherApy on Radial Artery Occlusion after transradial coronary angiography and patent Hemostasis (PHARAOH) study compares the strategy of standard a-priori heparin use in patients undergoing transradial coronary angiography to a strategy of provisional heparin administration only if patent hemostasis is not achievable.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
428

participants targeted

Target at P50-P75 for not_applicable coronary-artery-disease

Timeline
Completed

Started May 2009

Geographic Reach
3 countries

3 active sites

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

Study Start

First participant enrolled

May 1, 2009

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

December 1, 2011

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 12, 2011

Completed
Last Updated

May 8, 2012

Status Verified

December 1, 2011

Enrollment Period

2.6 years

First QC Date

December 1, 2011

Last Update Submit

May 7, 2012

Conditions

Coronary Artery Disease

Keywords

radial artery occlusionhemostasiscoronary interventionradial approach

Outcome Measures

Primary Outcomes (1)

  • Radial artery occlusion

    Plethysmography, confirmed with duplex Doppler ultrasonography

    At 30 days after the cathlab procedure

Secondary Outcomes (1)

  • Radial artery occlusion

    At 24 hours after the cathlab procedure

Study Arms (2)

Compression without adjustment

NO INTERVENTION

TR band (Terumo medical) applied. The TR band is then deflated gradually till pulsatile bleeding is observed under the transparent plastic inflatable chamber and then 1-2 cc of air is placed back in the TR band chamber to stop bleeding. The band is left in place for 2 hours and not adjusted further unless patient complained of symptoms or bleeding occurred.

Patent hemostasis & heparin

EXPERIMENTAL

TR-band is placed and positioned similarly to the other study arm. However, in theses cases, patency is evaluated at the time of application of the TR-band, and monitored every 15 minutes afterwards till the band is removed and hemostasis completed. After TR-band placement, if maintenance of radial artery patency is obtained, no heparin is administered and TR band is left in place for 1-hour. If radial artery patency is not maintained, a bolus of heparin 50 U/kg or a maximum of 5000 units is administered and the band is left in place for 2 hours.

Other: Patent hemostasis and heparin

Interventions

Patent hemostasis and heparinOTHER

Radial artery patency is verified. If not maintained, then a bolus of heparin 50 U/kg or a maximum of 5000 units is administered and the compression (TR band) is left in place for 2 hours.

Patent hemostasis & heparin

Eligibility Criteria

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

You may qualify if:

  • all diagnostic cardiac cath patients

You may not qualify if:

  • warfarin therapy
  • previous ipsilateral TRA
  • lack of consent
  • abnormal (type D) Barbeau test
  • scleroderma
  • thrombocytopenia
  • or other contraindications to heparin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Commonwealth Medical College,

Scranton, Pennsylvania, 18509, United States

Location

IUCPQ

Québec, Quebec, Canada

Location

Sheth VS General Hospital,

Ahmedabad, India

Location

MeSH Terms

Conditions

Coronary Artery DiseaseArterial Occlusive Diseases

Interventions

Heparin

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisVascular Diseases

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Samir B. Pancholy, MD

    TCMC, Scranton (PA, USA)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Project Leader Transradial Research and Education Fund

Study Record Dates

First Submitted

December 1, 2011

First Posted

December 12, 2011

Study Start

May 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

May 8, 2012

Record last verified: 2011-12

Locations

IN(1)CA(1)US(1)