NCT01260519

Brief Summary

The project tests the incidence of femoral arterial sheath thrombus formation during diagnostic coronary angiography and effect of intravenous (iv) heparin bolus administration in reducing this risk in comparison to placebo.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
304

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 2008

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

Study Start

First participant enrolled

July 1, 2008

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2010

Completed
26 days until next milestone

First Posted

Study publicly available on registry

December 15, 2010

Completed
Last Updated

December 15, 2010

Status Verified

December 1, 2010

Enrollment Period

2.3 years

First QC Date

November 19, 2010

Last Update Submit

December 14, 2010

Conditions

Diagnostic Coronary Angiography

Outcome Measures

Primary Outcomes (1)

  • The incidence of femoral arterial sheath thrombi and the efficacy of heparin bolus in preventing sheath thrombosis

Study Arms (1)

active arm: heparin

EXPERIMENTAL
Drug: Heparin

Interventions

HeparinDRUG

unfractionated heparin 2000 unites

Also known as: unfractionated heparin
active arm: heparin

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Included all adult patients undergoing cardiac catheterization

You may not qualify if:

  • Contraindication to heparin
  • Platelet count \<100,000/mm3
  • Patient with bleeding diathesis or hypercoagulable state.
  • Use of chronic anticoagulation with INR \> 1.4
  • Patient refusal or inability to follow the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince Sultan Cardiac Center

Riyadh, Central, 11159, Saudi Arabia

Location

MeSH Terms

Interventions

Heparin

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Abdulrahman M Almoghairi, MD

    Prince Sultan Cardiac Centre (PSCC)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 19, 2010

First Posted

December 15, 2010

Study Start

July 1, 2008

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

December 15, 2010

Record last verified: 2010-12

Locations

SA(1)