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BruisesPhase 4NCT00253396

Patients Preference With Self-Injection: The PRISM Study

A Phase 4 study testing Unfractionated heparin and Enoxaparin in people with Bruises, run by Hamilton Health Sciences Corporation at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Bruises
What is being tested?
Unfractionated heparin and Enoxaparin
How many people
100 participants
Where
1 siteCanada
Study dates
Oct 2005to Jan 2007
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • St. Joseph's Healthcare

    Hamilton, Ontario, L8N 4A6

Other trials in Canada

About this 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

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.

Read the 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.

Conditions
Bruises
Being tested
Unfractionated heparin, Enoxaparin
Keywords
warfarin, clinical trial, pain measurement, heparin, heparin, low-molecular-weight, Anticoagulants
Medical subject headings
Contusions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Unfractionated heparinDrug

  • EnoxaparinDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

  1. On the day of the procedure, bruising at injection sites will be evaluated.

  2. 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2005 (estimated)
  2. Study startOct 2005
  3. Study completionJan 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00253396
Sponsor's protocol ID
05-2482
Status last verified
May 2007
First submitted
14 Nov 2005
Last updated
10 Mar 2009
Results posted
No
Data monitoring committee
No

Publications

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

    PubMed 10865654

  • 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.

    PubMed 10661066

  • 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.

    PubMed 8630132

  • 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.

    PubMed 8811149

  • 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.

    PubMed 12586125

  • 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.

    PubMed 12719198

  • 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.

    PubMed 14650471

  • 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.

    PubMed 15162899

  • 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.

    PubMed 11157643

  • 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.

    PubMed 10647756

  • 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.

    PubMed 15383479

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Unfractionated heparin and Enoxaparin in people with Bruises, run by Hamilton Health Sciences Corporation at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00253396, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2009.

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