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Patients Preference With Self-Injection: The PRISM Study
This study is currently recruiting participants.
Verified by McMaster University, May 2007
Sponsors and Collaborators: Hamilton Health Sciences
St. Joseph's Healthcare
Information provided by: McMaster University
ClinicalTrials.gov Identifier: NCT00253396
  Purpose

The purpose of this study is to determine which short-acting blood thinner (low-molecular-weight heparin [Enoxaparin] or unfractionated heparin) is associated with less discomfort and bruising when given as a subcutaneous (under the skin) injection before and after a planned surgery or procedure in patients who temporarily stop warfarin.


Condition Intervention Phase
Bruises
Drug: Unfractionated heparin
Drug: Enoxaparin
Phase IV

MedlinePlus related topics: Blood Thinners Bruises
Drug Information available for: Warfarin Warfarin potassium Warfarin sodium Heparin Enoxaparin Sodium
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: THE PRISM Study-Low-Molecular-Weight Heparin Versus Unfractionated Heparin for Perioperative Bridging Anticoagulation: the Patient Preference for Self-Injection Study and Related Measurements

Further study details as provided by McMaster University:

Primary Outcome Measures:
  • The primary outcome measure is self-reported comfort score based on a visual analogue scale (VAS). Patients will complete a 10-point VAS. Patients will complete a VAS at the time of injection.

Secondary Outcome Measures:
  • On the day of the procedure, bruising at injection sites will be evaluated.
  • Patients will document in a diary each injection before and after the surgery or invasive procedure. On the day of surgery or procedure abdominal bruising measurement will be obtained. A digital photo will be take of the injection site.

Estimated Enrollment: 100
Study Start Date: October 2005
Estimated Study Completion Date: October 2008
Detailed Description:

Increasing Patient Comfort and Compliance: The Bridging Anticoagulation Clinic strives to provide the highest quality of care to patients who require temporary interruption of warfarin therapy. An important component of optimizing patient care is minimizing patient discomfort with perioperative administration of short-acting anticoagulants (LWMH or UFH) used for bridging therapy, which, in turn, may optimize patient compliance with this treatment. This issue is especially relevant for patients who are receiving out-of-hospital treatment with LMWH or UFH because about 85% of such patients will be taught to self-administer this medication. This study seeks to determine if there is less discomfort and bruising associated with self-injection of LMWH than with UFH.

Minimizing Injection Site Bruising: No studies, to our knowledge, have assessed the characteristics or clinical importance of bruising in patients receiving subcutaneous LMWH or UFH. Thus, there is no evidence to support any association between bruising and discomfort. To bridge this gap in knowledge, we will document each injection site during the course of the study and measure the amount of bruising observed using a standardized photographic methodology. Injection site bruising has the potential to cause medical problems if an injection site hematoma develops, which can become infected or can cause long-term discomfort.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patient is receiving warfarin therapy with a target international normalized ratio (INR) of 2.0-3.5
  2. Patient requires temporary interruption of warfarin because of elective surgery or procedure.

Exclusion Criteria:

  1. History of allergy to heparin, including heparin-induced thrombocytopenia (HIT)
  2. Bridging anticoagulation with low molecular weight heparin (LMWH) or unfractionated heparin (UFH) not indicated
  3. Impaired cognitive function or language barrier
  4. Creatinine clearance < 30 ml/min
  5. Patient declines consent
  6. Patient is < 18 years of age.
  7. Patient is not willing and able to self inject.
  8. Patient has significant visual or hand motor impairment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00253396

Contacts
Contact: Karen Woods, RN 905-522-1155 ext 3754 kwoods@mcmaster.ca
Contact: James D Douketis, MD 905-522-1155 ext 6178 jdouket@mcmaster.ca

Locations
Canada, Ontario
St. Joseph's Healthcare Recruiting
Hamilton, Ontario, Canada, L8N 4A6
Contact: Karen Woods, RN     905-522-1155 ext 3754     kwoods@mcmaster.ca    
Contact: James Douketis, MD     905-522-1155 ext 6178     jdouket@mcmaster.ca    
Principal Investigator: Karen Woods, RN            
Sponsors and Collaborators
Hamilton Health Sciences
St. Joseph's Healthcare
Investigators
Principal Investigator: Co-Investigators Dr. James Douketis and Karen Woods RN McMaster University
  More Information

Publications of Results:
Letizia M, Shenk J, Jones TD. Intermittent subcutaneous injections of pain medication: effectiveness, manageability, and satisfaction. Am J Hosp Palliat Care. 1999 Jul-Aug;16(4):585-92.
Martin S, Jones JS, Wynn BN. Does warming local anesthetic reduce the pain of subcutaneous injection? Am J Emerg Med. 1996 Jan;14(1):10-2.
Hadley SA, Chang M, Rogers K. Effect of syringe size on bruising following subcutaneous heparin injection. Am J Crit Care. 1996 Jul;5(4):271-6.
Douketis JD. Perioperative anticoagulation management in patients who are receiving oral anticoagulant therapy: a practical guide for clinicians. Thromb Res. 2002 Oct 1;108(1):3-13. Review.
Dunn AS, Turpie AG. Perioperative management of patients receiving oral anticoagulants: a systematic review. Arch Intern Med. 2003 Apr 28;163(8):901-8. Review.
Jaffer AK, Brotman DJ, Chukwumerije N. When patients on warfarin need surgery. Cleve Clin J Med. 2003 Nov;70(11):973-84. Review.
Spyropoulos AC, Jenkins P, Bornikova L. A disease management protocol for outpatient perioperative bridge therapy with enoxaparin in patients requiring temporary interruption of long-term oral anticoagulation. Pharmacotherapy. 2004 May;24(5):649-58.
Hirsh J, Warkentin TE, Shaughnessy SG, Anand SS, Halperin JL, Raschke R, Granger C, Ohman EM, Dalen JE. Heparin and low-molecular-weight heparin: mechanisms of action, pharmacokinetics, dosing, monitoring, efficacy, and safety. Chest. 2001 Jan;119(1 Suppl):64S-94S. Review. No abstract available.
Dolovich LR, Ginsberg JS, Douketis JD, Holbrook AM, Cheah G. A meta-analysis comparing low-molecular-weight heparins with unfractionated heparin in the treatment of venous thromboembolism: examining some unanswered questions regarding location of treatment, product type, and dosing frequency. Arch Intern Med. 2000 Jan 24;160(2):181-8.
Buller HR, Agnelli G, Hull RD, Hyers TM, Prins MH, Raskob GE. Antithrombotic therapy for venous thromboembolic disease: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest. 2004 Sep;126(3 Suppl):401S-428S. Review. Erratum in: Chest. 2005 Jan;127(1):416.

Other Publications:
Study ID Numbers: 05-2482
Study First Received: November 14, 2005
Last Updated: July 11, 2007
ClinicalTrials.gov Identifier: NCT00253396  
Health Authority: Canada: Health Canada

Keywords provided by McMaster University:
warfarin
clinical trial
pain measurement
heparin
heparin, low-molecular-weight
Anticoagulants

Study placed in the following topic categories:
Body Weight
Contusions
Heparin, Low-Molecular-Weight
Pain
Warfarin
Heparin
Enoxaparin
Calcium heparin

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

ClinicalTrials.gov processed this record on January 14, 2009