Trial Outcomes & Findings for Comparison of Arixtra vs. Lovenox to Prevent Blood Clots in Medically Ill Patients (NCT NCT00521885)

Results Overview

Bleeding Rate- Major bleeding defined as one or a combination of the following: Fatal; Bleeding at critical organ sites (intracranial, retroperitoneal, intraocular, pericardial, spinal or adrenal). Minor Bleeding defined as clinically overt bleeding that is not major bleeding.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

1 participants

Primary outcome timeframe

14 days

Results posted on

2021-10-29

Participant Flow

Unable to recruit suitable subjects is the reason this study was terminated early

one patient was a screened failure- after consent found to have an exclusion criteria during screening

Participant milestones

Participant milestones
Measure	Arixtra (Fondaparinox) 2.5 mg Given Subcutaneously (SC) Daily In this arm subjects will be randomized to Arixtra (Fondaparinox) 2.5 mg given Subcutaneously (SC) once a day starting on day 1 and continuing through day 14 or day of discharge, whichever comes first. Arixtra: Arixtra 2.5mg Sc Daily	Lovenox 40mg Subcutaneously (SC) Daily Subjects will be randomized using a random generated listing of numbers with arm assignments associated with each assigned number. Only the study pharmacist will have access to this randomization code. All other study team members will remain blinded to the treatment arm. In this arm subjects will be randomized to Lovenox 40mg Subcutaneously (SC) Daily starting on day 1 and continuing through day 14 or day of discharge, whichever comes first. Lovenox: Lovenox 40mg SC Daily
Overall Study STARTED	0	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Arixtra vs. Lovenox to Prevent Blood Clots in Medically Ill Patients

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: 14 days

Population: There was only 1 patient enrolled and it is not documented anywhere which group they were assigned to- the study is so old and no one is here who would know; therefore I cannot verify any patients in either group

Bleeding Rate- Major bleeding defined as one or a combination of the following: Fatal; Bleeding at critical organ sites (intracranial, retroperitoneal, intraocular, pericardial, spinal or adrenal). Minor Bleeding defined as clinically overt bleeding that is not major bleeding.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 14 Days

Population: There was 1 patient enrolled and it is not documented which group the patient was assigned therefore I cannot verify which group the patient should be included.

Confirmed by Lower Extremity Ultra-sonogram

Outcome measures

Outcome data not reported

Adverse Events

Arixtra (Fondaparinox) 2.5 mg Given SC Daily

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lovenox 40mg SC 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

Leslie Baga, Director of Research

Lehigh Valley Health Network

Phone: 610 402 1285

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place