Trial Outcomes & Findings for Once Daily Enoxaparin for Outpatient Treatment of Acute DVT and/or Pulmonary Embolism (NCT NCT00413374)

Results Overview

Major bleeding complication as defined as spinal, retroperitoneal, or intracranial bleeding; drop in hemoglobin ≥2g/dl or transfusion ≥2U or surgical or medical intervention, death related to bleeding.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

30 Days

Results posted on

2018-06-28

Participant Flow

Enrollment began in September 2006 and was completed in March 2008. Of 473 patients screened, 40 were enrolled. Patients with newly diagnosed acute DVT or PE were screened in the Emergency Department or Vascular Laboratory at Brigham and Women's Hospital.

Unit of analysis: patients

Participant milestones

Participant milestones
Measure	Enoxaparin 1.5 mg/kg Daily the cases were started on 1.5 mg/kg once daily enoxaparin as a bridge to warfarin.	Enoxaparin 1 mg/kg Twice Daily The controls had been treated with enoxaparin 1 mg/kg twice daily as a ''bridge'' to warfarin. These are historical controls. Two previously treated controls were matched for each case. Controls were matched by age (+10 years), gender, and location of VTE. The controls had been treated with enoxaparin 1 mg/kg twice daily as a ''bridge'' to warfarin.
Overall Study STARTED	40 40	80 80
Overall Study COMPLETED	34 34	80 80
Overall Study NOT COMPLETED	6 6	0 0

Reasons for withdrawal

Reasons for withdrawal
Measure	Enoxaparin 1.5 mg/kg Daily the cases were started on 1.5 mg/kg once daily enoxaparin as a bridge to warfarin.	Enoxaparin 1 mg/kg Twice Daily The controls had been treated with enoxaparin 1 mg/kg twice daily as a ''bridge'' to warfarin. These are historical controls. Two previously treated controls were matched for each case. Controls were matched by age (+10 years), gender, and location of VTE. The controls had been treated with enoxaparin 1 mg/kg twice daily as a ''bridge'' to warfarin.
Overall Study Ineligible due to screening criteria.	3	0
Overall Study Adverse Event	1	0
Overall Study Lost to Follow-up	1	0
Overall Study Surgery	1	0

Baseline Characteristics

Once Daily Enoxaparin for Outpatient Treatment of Acute DVT and/or Pulmonary Embolism

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Enoxaparin 1.5 mg/kg Daily n=40 Participants	Enoxaparin 1 mg/kg Twice Daily n=80 Participants	Total n=120 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	35 Participants n=5 Participants	75 Participants n=7 Participants	110 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Age, Continuous	47.95 years STANDARD_DEVIATION 16.2 • n=5 Participants	48.53 years STANDARD_DEVIATION 15.3 • n=7 Participants	48 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	42 Participants n=7 Participants	63 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	38 Participants n=7 Participants	57 Participants n=5 Participants
Region of Enrollment United States	40 participants n=5 Participants	80 participants n=7 Participants	120 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 Days

Major bleeding complication as defined as spinal, retroperitoneal, or intracranial bleeding; drop in hemoglobin ≥2g/dl or transfusion ≥2U or surgical or medical intervention, death related to bleeding.

Outcome measures

Outcome measures
Measure	Enoxaparin 1.5 mg/kg Daily n=40 Participants Study participants receiving Enoxaparin once daily who developed a major bleeding complication within 30 days.	Enoxaparin 1 mg/kg Twice Daily n=80 Participants
Major Bleeding Complication	0 participants	3 participants

PRIMARY outcome

Timeframe: 30 Days

Major clotting complication (recurrent VTE) as defined as recurrent acute pulmonary embolism confirmed on chest CT or recurrent deep vein thrombosis in the contralateral extremity confirmed with venous ultrasound or CT scan while on once daily enoxaparin therapy.

Outcome measures

Outcome measures
Measure	Enoxaparin 1.5 mg/kg Daily n=40 Participants Study participants receiving Enoxaparin once daily who developed a major bleeding complication within 30 days.	Enoxaparin 1 mg/kg Twice Daily n=80 Participants
Recurrent VTE	1 participants	3 participants

PRIMARY outcome

Timeframe: 30 Days

Population: Intention to treat

All-cause mortality

Outcome measures

Outcome measures
Measure	Enoxaparin 1.5 mg/kg Daily n=40 Participants Study participants receiving Enoxaparin once daily who developed a major bleeding complication within 30 days.	Enoxaparin 1 mg/kg Twice Daily n=80 Participants
Death	0 Participants	0 Participants

Adverse Events

Enoxaparin 1.5 mg/kg Daily

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Enoxaparin 1 mg/kg Twice Daily

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Enoxaparin 1.5 mg/kg Daily n=40 participants at risk Recieved low molecular weight heparin (LMWH) as a "bridge" to warfarin	Enoxaparin 1 mg/kg Twice Daily n=80 participants at risk
Cardiac disorders Recurrent VTE	2.5% 1/40 • Number of events 1	3.8% 3/80 • Number of events 3

Other adverse events

Adverse event data not reported

Additional Information

Research Coordinator

Brigham and Women's Hospital

Phone: 617-732-6984

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place