Trial Outcomes & Findings for Delayed Versus Early Enoxaparin Prophylaxis After Traumatic Brain Injury (TBI) (NCT NCT01014403)

NCT ID: NCT01014403

Last Updated: 2021-01-13

Results Overview

Worsening of TBI hemorrhage pattern on any scheduled or PRN CT scans after the initiation of treatment

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 62 participants
• Primary outcome timeframe: 24 hours after the start of treatment/48 hours after the time of injury
• Results posted on: 2021-01-13

Participant Flow

Participant milestones

Measure	Enoxaparin 30 mg SQ q12 Hours Enoxaparin started at 24 hours post-injury and continued until 96 hours post-injury. enoxaparin: Enoxaparin 30 mg sq q 12 hours	Placebo vehicle administered sq q 12 hours placebo: vehicle
Overall Study STARTED	34	28
Overall Study COMPLETED	34	28
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Delayed Versus Early Enoxaparin Prophylaxis After Traumatic Brain Injury (TBI)

Baseline characteristics by cohort

Measure	Enoxaparin 30 mg SQ q12 Hours n=34 Participants Enoxaparin started at 24 hours post-injury and continued until 96 hours post-injury. enoxaparin: Enoxaparin 30 mg sq q 12 hours	Placebo n=28 Participants vehicle administered sq q 12 hours placebo: vehicle	Total n=62 Participants Total of all reporting groups
Age, Continuous	40 years STANDARD_DEVIATION 19 • n=93 Participants	42 years STANDARD_DEVIATION 17 • n=4 Participants	41 years STANDARD_DEVIATION 18 • n=27 Participants
Sex: Female, Male Female	12 Participants n=93 Participants	12 Participants n=4 Participants	24 Participants n=27 Participants
Sex: Female, Male Male	22 Participants n=93 Participants	16 Participants n=4 Participants	38 Participants n=27 Participants

PRIMARY outcome

Timeframe: 24 hours after the start of treatment/48 hours after the time of injury

Worsening of TBI hemorrhage pattern on any scheduled or PRN CT scans after the initiation of treatment

Outcome measures

Measure	Enoxaparin 30 mg SQ q12 Hours n=34 Participants Enoxaparin started at 24 hours post-injury and continued until 96 hours post-injury. enoxaparin: Enoxaparin 30 mg sq q 12 hours	Placebo n=28 Participants vehicle administered sq q 12 hours placebo: vehicle
Percentage of Participants With Worsening TBI Hemorrhage	5.9 percentage of participants Interval 0.7 to 19.7	3.6 percentage of participants Interval 0.1 to 18.3

SECONDARY outcome

Timeframe: prior to discharge

percentage of participants that have extracranial hemorrhagic complications

Outcome measures

Measure	Enoxaparin 30 mg SQ q12 Hours n=34 Participants Enoxaparin started at 24 hours post-injury and continued until 96 hours post-injury. enoxaparin: Enoxaparin 30 mg sq q 12 hours	Placebo n=28 Participants vehicle administered sq q 12 hours placebo: vehicle
Extracranial Hemorrhagic Complications	0 Participants	0 Participants

SECONDARY outcome

Timeframe: prior to discharge

Outcome measures

Measure	Enoxaparin 30 mg SQ q12 Hours n=34 Participants Enoxaparin started at 24 hours post-injury and continued until 96 hours post-injury. enoxaparin: Enoxaparin 30 mg sq q 12 hours	Placebo n=28 Participants vehicle administered sq q 12 hours placebo: vehicle
Count of Participants With Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)	0 Participants	1 Participants

Adverse Events

Enoxaparin 30 mg SQ q12 Hours

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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. Herb Phelan

UT Southwestern Medical Center

Phone: 214-648-6841

Email: herb.phelan@utsouthwestern.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place