Trial Outcomes & Findings for Study to Evaluate Weight-based Enoxaparin Dosing in Obese Medical Patients at Risk for DVT (NCT NCT00585182)

Results Overview

The Rotachrom® assay using the STA-Compact instrument (Diagnostica Stago, Parsippany, NJ) was used to quantitate anti- Xa (LMWH) activity for enoxaparin. The sensitivity of this assay is 0.2 U/mL and within run imprecision is 5.5 (% CV) at 1 U/mL. The assay is linear between 0.2-2.0 U/mL

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

28 participants

Primary outcome timeframe

4 - 6 hours after enoxaparin dosing on Day 1 and Day 2

Results posted on

2018-04-05

Participant Flow

28 patients met eligibility criteria and completed the protocol enrolled from the University of Utah Hospital Inpatient Medical Service

Participant milestones

Participant milestones
Measure	Enoxaparin 0.5mg/kg Once Daily
Overall Study STARTED	28
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Evaluate Weight-based Enoxaparin Dosing in Obese Medical Patients at Risk for DVT

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Enoxaparin 0.5mg/kg Once Daily n=28 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Age, Continuous	54 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Region of Enrollment United States	28 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 - 6 hours after enoxaparin dosing on Day 1 and Day 2

The Rotachrom® assay using the STA-Compact instrument (Diagnostica Stago, Parsippany, NJ) was used to quantitate anti- Xa (LMWH) activity for enoxaparin. The sensitivity of this assay is 0.2 U/mL and within run imprecision is 5.5 (% CV) at 1 U/mL. The assay is linear between 0.2-2.0 U/mL

Outcome measures

Outcome measures
Measure	Enoxaparin 0.5mg/kg Once Daily n=28 Participants
Peak Low Molecular Weight Heparin Anti-Xa Activity Level.	0.25 IU/mL Standard Deviation 0.11

SECONDARY outcome

Timeframe: Participants were followed for the duration of hospital stay, an average of 5 days

Clinically Relevant Bleeding is defined as fatal bleeding, symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, bleeding causing a fall in hemoglobin level of 2 g/dL (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells, or bleeding requiring intervention

Outcome measures

Outcome measures
Measure	Enoxaparin 0.5mg/kg Once Daily n=28 Participants
Clinically Relevant Bleeding Events	0 Events

Adverse Events

Enoxaparin 0.5mg/kg Once Daily

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Robert Pendleton

University of Utah

Phone: 801 581 7818

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place