Patients Preference With Self-Injection: The PRISM Study

NCT00253396 | Completed Phase 4

• 1 other identifier: 05-2482
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bruises

Keywords

warfarin; clinical trial; pain measurement; heparin; heparin, low-molecular-weight; Anticoagulants

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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.

Interventions

Unfractionated heparin DRUG

Enoxaparin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• History of allergy to heparin, including heparin-induced thrombocytopenia (HIT)
• Bridging anticoagulation with low molecular weight heparin (LMWH) or unfractionated heparin (UFH) not indicated
• Impaired cognitive function or language barrier
• Creatinine clearance \< 30 ml/min
• Patient declines consent
• Patient is \< 18 years of age.
• Patient is not willing and able to self inject.
• Patient has significant visual or hand motor impairment

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• St. Joseph's Health Care London: collaborator

Study Sites (1)

St. Joseph's Healthcare

Hamilton, Ontario, L8N 4A6, Canada

Location

Related Publications (11)

• McConnell EA. Administering subcutaneous heparin. Nursing. 2000 Jun;30(6):17. doi: 10.1097/00152193-200030060-00004. No abstract available.

  PMID: 10865654 BACKGROUND

• 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.

  PMID: 10661066 RESULT

• 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.

  PMID: 8630132 RESULT

• 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.

  PMID: 8811149 RESULT

• 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.

  PMID: 12586125 RESULT

• 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.

  PMID: 12719198 RESULT

• 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.

  PMID: 14650471 RESULT

• 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.

  PMID: 15162899 RESULT

• 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.

  PMID: 11157643 RESULT

• 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.

  PMID: 10647756 RESULT

• 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.

  PMID: 15383479 RESULT

MeSH Terms

Conditions

Contusions

Interventions

Heparin; Enoxaparin

Condition Hierarchy (Ancestors)

Wounds, Nonpenetrating; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Heparin, Low-Molecular-Weight

Study Officials

• Co-Investigators Dr. James Douketis and Karen Woods RN

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 14, 2005
• First Posted: November 15, 2005
• Study Start: October 1, 2005
• Study Completion: January 1, 2007
• Last Updated: March 10, 2009

Record last verified: 2007-05

Locations

CA (1)