Patients Preference With Self-Injection: The PRISM Study
NCT ID: NCT00253396
Last Updated: 2009-03-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
100 participants
INTERVENTIONAL
2005-10-31
2007-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Unfractionated heparin
Enoxaparin
Eligibility Criteria
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Inclusion Criteria
2. Patient requires temporary interruption of warfarin because of elective surgery or procedure.
Exclusion Criteria
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
18 Years
ALL
Yes
Sponsors
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St. Joseph's Health Care London
OTHER
Hamilton Health Sciences Corporation
OTHER
Principal Investigators
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Co-Investigators Dr. James Douketis and Karen Woods RN
Role: PRINCIPAL_INVESTIGATOR
McMaster University
Locations
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St. Joseph's Healthcare
Hamilton, Ontario, Canada
Countries
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References
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McConnell EA. Administering subcutaneous heparin. Nursing. 2000 Jun;30(6):17. doi: 10.1097/00152193-200030060-00004. No abstract available.
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. doi: 10.1177/104990919901600407.
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. doi: 10.1016/S0735-6757(96)90003-0.
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. doi: 10.1016/s0049-3848(02)00387-0.
Dunn AS, Turpie AG. Perioperative management of patients receiving oral anticoagulants: a systematic review. Arch Intern Med. 2003 Apr 28;163(8):901-8. doi: 10.1001/archinte.163.8.901.
Jaffer AK, Brotman DJ, Chukwumerije N. When patients on warfarin need surgery. Cleve Clin J Med. 2003 Nov;70(11):973-84. doi: 10.3949/ccjm.70.11.973.
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. doi: 10.1592/phco.24.6.649.34740.
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. doi: 10.1378/chest.119.1_suppl.64s. 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. doi: 10.1001/archinte.160.2.181.
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. doi: 10.1378/chest.126.3_suppl.401S.
Other Identifiers
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05-2482
Identifier Type: -
Identifier Source: org_study_id
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