Effect of Heparin on Femoral Arterial Sheaths Thrombosis During Diagnostic Coronary Angiography

This study has been completed.
Sponsor:
Information provided by:
Prince Sultan Cardiac Center, Adult Cardiology Department.
ClinicalTrials.gov Identifier:
NCT01260519
First received: November 19, 2010
Last updated: December 14, 2010
Last verified: December 2010
  Purpose

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.


Condition Intervention Phase
Diagnostic Coronary Angiography
Drug: Heparin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy of a Single Dose Intravenous Heparin During Diagnostic Angiography in Reducing Sheath-clot Formation: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Prince Sultan Cardiac Center, Adult Cardiology Department.:

Primary Outcome Measures:
  • The incidence of femoral arterial sheath thrombi and the efficacy of heparin bolus in preventing sheath thrombosis [ Designated as safety issue: Yes ]

Enrollment: 304
Study Start Date: July 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: active arm: heparin Drug: Heparin
unfractionated heparin 2000 unites
Other Name: unfractionated heparin

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Included all adult patients undergoing cardiac catheterization

Exclusion Criteria:

  • 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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01260519

Locations
Saudi Arabia
Prince Sultan Cardiac Center
Riyadh, Central, Saudi Arabia, 11159
Sponsors and Collaborators
Prince Sultan Cardiac Center, Adult Cardiology Department.
Investigators
Principal Investigator: Abdulrahman M Almoghairi, MD Prince Sultan Cardiac Centre (PSCC)
  More Information

No publications provided

Responsible Party: Abdulrahman M Al-Moghairi,MD,MRCP, SFC, Prince Sultan Cardiac Center, Adult Cardiology Department.
ClinicalTrials.gov Identifier: NCT01260519     History of Changes
Other Study ID Numbers: PSCC-00001- HT
Study First Received: November 19, 2010
Last Updated: December 14, 2010
Health Authority: Saudi Arabia: Ethics Committee

Additional relevant MeSH terms:
Calcium heparin
Heparin
Anticoagulants
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014