Trial Outcomes & Findings for PREvention of VENous Thromboembolism In Hemorrhagic Stroke Patients (NCT NCT01573169)

Results Overview

Symptomatic venous thromboembolism (deep venous thrombosis and/or pulmonary embolism) and asymptomatic deep venous thrombosis on ultrasound examination

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

73 participants

Primary outcome timeframe

10 days

Results posted on

2021-09-10

Participant Flow

No wash-out, nor run-in events.

Participant milestones

Participant milestones
Measure	Low Weight Molecular Heparin enoxaparin 0.4 ml subcutaneous per day Enoxaparin: enoxaparin 0.4 ml sc per day for 10 days started 72 hours after the stroke	Standard Therapy Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization: placebo standard therapy
Overall Study STARTED	38	35
Overall Study COMPLETED	38	35
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Low Weight Molecular Heparin n=38 Participants enoxaparin 0.4 ml subcutaneous per day Enoxaparin: enoxaparin 0.4 ml sc per day for 10 days started 72 hours after the stroke	Standard Therapy n=35 Participants Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization: placebo standard therapy	Total n=73 Participants Total of all reporting groups
Age, Continuous	70.4 years STANDARD_DEVIATION 13.7 • n=38 Participants	71.5 years STANDARD_DEVIATION 11.6 • n=35 Participants	70.9 years STANDARD_DEVIATION 12.6 • n=73 Participants
Sex: Female, Male Female	16 Participants n=38 Participants	17 Participants n=35 Participants	33 Participants n=73 Participants
Sex: Female, Male Male	22 Participants n=38 Participants	18 Participants n=35 Participants	40 Participants n=73 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Obesity	3 Participants n=38 Participants	3 Participants n=35 Participants	6 Participants n=73 Participants

PRIMARY outcome

Timeframe: 10 days

Symptomatic venous thromboembolism (deep venous thrombosis and/or pulmonary embolism) and asymptomatic deep venous thrombosis on ultrasound examination

Outcome measures

Outcome measures
Measure	Low Weight Molecular Heparin n=38 Participants enoxaparin 0.4 ml subcutaneous per day Enoxaparin: enoxaparin 0.4 ml sc per day for 10 days started 72 hours after the stroke	Standard Therapy n=35 Participants Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization: placebo standard therapy
Number of Participants With Symptomatic and Asymptomatic Venous Thromboembolism	6 Participants	7 Participants

SECONDARY outcome

Timeframe: 90 days

symptomatic and asymptomatic intra and extracranial bleedings

Outcome measures

Outcome measures
Measure	Low Weight Molecular Heparin n=38 Participants enoxaparin 0.4 ml subcutaneous per day Enoxaparin: enoxaparin 0.4 ml sc per day for 10 days started 72 hours after the stroke	Standard Therapy n=35 Participants Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization: placebo standard therapy
Bleedings	1 Participants	3 Participants

SECONDARY outcome

Timeframe: 90 days

mortality of any cause

Outcome measures

Outcome measures
Measure	Low Weight Molecular Heparin n=38 Participants enoxaparin 0.4 ml subcutaneous per day Enoxaparin: enoxaparin 0.4 ml sc per day for 10 days started 72 hours after the stroke	Standard Therapy n=35 Participants Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization: placebo standard therapy
Mortality	7 Participants	6 Participants

SECONDARY outcome

Timeframe: 90 days

modified Rankin Scale (mRS) equal to and greater than 3. 0 - No symptoms. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead.

Outcome measures

Outcome measures
Measure	Low Weight Molecular Heparin n=38 Participants enoxaparin 0.4 ml subcutaneous per day Enoxaparin: enoxaparin 0.4 ml sc per day for 10 days started 72 hours after the stroke	Standard Therapy n=35 Participants Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization: placebo standard therapy
Disability	27 Participants	30 Participants

Adverse Events

Low Weight Molecular Heparin

Serious events: 1 serious events

Other events: 0 other events

Deaths: 7 deaths

Standard Therapy

Serious events: 3 serious events

Other events: 0 other events

Deaths: 6 deaths

Serious adverse events

Serious adverse events
Measure	Low Weight Molecular Heparin n=38 participants at risk enoxaparin 0.4 ml subcutaneous per day Enoxaparin: enoxaparin 0.4 ml sc per day for 10 days started 72 hours after the stroke	Standard Therapy n=35 participants at risk Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization: placebo standard therapy
Respiratory, thoracic and mediastinal disorders extracranial bleeding	2.6% 1/38 • Number of events 1 • 3 months	0.00% 0/35 • 3 months
Nervous system disorders Intracranial bleedings	0.00% 0/38 • 3 months	8.6% 3/35 • Number of events 3 • 3 months

Other adverse events

Adverse event data not reported

Additional Information

Dr. Maurizio Paciaroni

Stroke Unit and Division of Internal and Cardiovascular Medicine University of Perugia, Santa Maria della Misericordia Hospital

Phone: +390755786424

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place