Patients Preference With Self-Injection: The PRISM Study

Bruises Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00253396
• Other study ID #: 05-2482
• Status: Completed
• Phase: Phase 4
• First received: November 14, 2005
• Last updated: March 9, 2009
• Start date: October 2005
• Est. completion date: January 2007

Study information

• Verified date: May 2007
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bruises

Intervention

Drug:
• Unfractionated heparin

• Enoxaparin

Locations

Country	Name	City	State
Canada	St. Joseph's Healthcare	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation	St. Joseph's Health Care London

Country where clinical trial is conducted

Canada, 

References & Publications (11)

Büller 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: Che — View Citation

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 treatmen — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

Jaffer AK, Brotman DJ, Chukwumerije N. When patients on warfarin need surgery. Cleve Clin J Med. 2003 Nov;70(11):973-84. Review. — View Citation

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. — View Citation

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. — View Citation

McConnell EA. Administering subcutaneous heparin. Nursing. 2000 Jun;30(6):17. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	On the day of the procedure, bruising at injection sites will be evaluated.
Secondary	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.