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

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ClinicalTrials.gov Identifier: NCT01260519
Recruitment Status : Completed
First Posted : December 15, 2010
Last Update Posted : December 15, 2010
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Diagnostic Coronary Angiography Drug: Heparin Phase 3

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 304 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : July 2008
Primary Completion Date : October 2010
Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: active arm: heparin Drug: Heparin
unfractionated heparin 2000 unites
Other Name: unfractionated heparin


Outcome Measures

Primary Outcome Measures :
  1. The incidence of femoral arterial sheath thrombi and the efficacy of heparin bolus in preventing sheath thrombosis

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: December 15, 2010    Key Record Dates
Last Update Posted: December 15, 2010
Last Verified: December 2010

Additional relevant MeSH terms:
Calcium heparin
Heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action