Individualised compared with conventional dosing of enoxaparin

A prospective, randomised study to investigate if a patient-individualised dose regimen of enoxaparin reduces the incidence of bleeding and bruising as compared to conventional dosing in patients with ACS, AF, DVT and PE.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000147583

Acronym

i-ENOX

Enrollment

120

Registered

2006-04-27

Start date

2004-05-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of this study is to see if a new dosing regimen of enoxaparin (an anticoagulant used in the treatment of heart attacks, deep vein thrombosis and pulmonary embolism) if safer than the current method of dosing (designed by the drug company). Patients will agree on being part of the study and then treated using one of the two methods (they will be unaware which group they will be in). The number of bleeding events and large bruises will be recorded for every patient. The two methods of dosing can then be compared at the end of the study to see which one has caused the least bleeding/bruising events). It is hope that the new dosing method will result in less events.

Interventions

Patients will be identified and consented by an investigator before or immediately after the first dose of enoxaparin. Patients will be randomised (using a randomisation table). The individualised arm (active) will recieve enoxaparin according to a new dosing strategy. The new dose strategy has been developed from two previous studies and uses lean body weight as the weight descriptor for dosing in obese (>100kg) patients (as opposed to the normal total body weight dosing). Patients with renal impairment will be dose reduced according to their renal function. All doses will be subcutaneous. The study started in May 2004 and will run for approximately 2 years, however an interim analysis was initiated in December 2005 and recruitment has not restarted (pending results). The study is suitably powered to 120 patients.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Any patient (male or female) initiated or about to be initiated on treatment doses of enoxaparin.

Exclusion criteria

Pregnancy, anticoagulation in the past 7 days, abnormal liver function test (more than twice the usual range).

Outcome results