Trial Outcomes & Findings for Beta Blockade in in Traumatic Brain Injury (NCT NCT02957331)

NCT ID: NCT02957331

Last Updated: 2020-06-04

Results Overview

Mortality will be assessed at day 30 or at hospital discharge

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 26 participants
• Primary outcome timeframe: 30 day
• Results posted on: 2020-06-04

Participant Flow

Participant milestones

Measure	Propranolol Arm One half of qualifying and consenting subjects will be randomized to receive propranolol. This group will receive study drug 3 times daily (every 8 hours) starting at 20 mg. The dosage may be increased by up to 60 mg/day divided over three daily doses (or an additional 20 mg/dose) as necessary until the heart rate is less than 100. Study drug will be held for hypotension (systolic \<100) or bradycardia (heart rate \<60 beats per minute). The maximum daily dose for the treatment of hypertension of 640 mg will not be exceeded in this study. Propranolol	Non Propranolol Arm Non beta blockade arm will receive standard of care treatment and will not receive beta blockade. If a subject randomized to no Inderal develops hypertension and increased heart rate, he/she will be treated according to standard of care by the trauma team caring for the patient.
Overall Study STARTED	14	12
Overall Study COMPLETED	13	12
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Propranolol Arm One half of qualifying and consenting subjects will be randomized to receive propranolol. This group will receive study drug 3 times daily (every 8 hours) starting at 20 mg. The dosage may be increased by up to 60 mg/day divided over three daily doses (or an additional 20 mg/dose) as necessary until the heart rate is less than 100. Study drug will be held for hypotension (systolic \<100) or bradycardia (heart rate \<60 beats per minute). The maximum daily dose for the treatment of hypertension of 640 mg will not be exceeded in this study. Propranolol	Non Propranolol Arm Non beta blockade arm will receive standard of care treatment and will not receive beta blockade. If a subject randomized to no Inderal develops hypertension and increased heart rate, he/she will be treated according to standard of care by the trauma team caring for the patient.
Overall Study Protocol Violation	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Propranolol Arm n=13 Participants One half of qualifying and consenting subjects will be randomized to receive propranolol. This group will receive study drug 3 times daily (every 8 hours) starting at 20 mg. The dosage may be increased by up to 60 mg/day divided over three daily doses (or an additional 20 mg/dose) as necessary until the heart rate is less than 100. Study drug will be held for hypotension (systolic \<100) or bradycardia (heart rate \<60 beats per minute). The maximum daily dose for the treatment of hypertension of 640 mg will not be exceeded in this study. Propranolol	Non Propranolol Arm n=12 Participants Non beta blockade arm will receive standard of care treatment and will not receive beta blockade. If a subject randomized to no Inderal develops hypertension and increased heart rate, he/she will be treated according to standard of care by the trauma team caring for the patient.	Total n=25 Participants Total of all reporting groups
Age, Continuous	49.7 years STANDARD_DEVIATION 19.0 • n=13 Participants	53.0 years STANDARD_DEVIATION 21.9 • n=12 Participants	51.3 years STANDARD_DEVIATION 20.1 • n=25 Participants
Sex: Female, Male Female	4 Participants n=13 Participants	5 Participants n=12 Participants	9 Participants n=25 Participants
Sex: Female, Male Male	9 Participants n=13 Participants	7 Participants n=12 Participants	16 Participants n=25 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 30 day

Mortality will be assessed at day 30 or at hospital discharge

Outcome measures

Measure	Propranolol Arm n=13 Participants One half of qualifying and consenting subjects will be randomized to receive propranolol. This group will receive study drug 3 times daily (every 8 hours) starting at 20 mg. The dosage may be increased by up to 60 mg/day divided over three daily doses (or an additional 20 mg/dose) as necessary until the heart rate is less than 100. Study drug will be held for hypotension (systolic \<100) or bradycardia (heart rate \<60 beats per minute). The maximum daily dose for the treatment of hypertension of 640 mg will not be exceeded in this study. Propranolol	Non Propranolol Arm n=12 Participants Non beta blockade arm will receive standard of care treatment and will not receive beta blockade. If a subject randomized to no Inderal develops hypertension and increased heart rate, he/she will be treated according to standard of care by the trauma team caring for the patient.
Mortality	7.7 percentage of participants	33.3 percentage of participants

SECONDARY outcome

Timeframe: Collected at baseline, Day 2, Day 5, Day 10 and Day 14.

Urine catecholamine levels will be measured in the hospital laboratory

Outcome measures

Measure	Propranolol Arm n=13 Participants One half of qualifying and consenting subjects will be randomized to receive propranolol. This group will receive study drug 3 times daily (every 8 hours) starting at 20 mg. The dosage may be increased by up to 60 mg/day divided over three daily doses (or an additional 20 mg/dose) as necessary until the heart rate is less than 100. Study drug will be held for hypotension (systolic \<100) or bradycardia (heart rate \<60 beats per minute). The maximum daily dose for the treatment of hypertension of 640 mg will not be exceeded in this study. Propranolol	Non Propranolol Arm n=12 Participants Non beta blockade arm will receive standard of care treatment and will not receive beta blockade. If a subject randomized to no Inderal develops hypertension and increased heart rate, he/she will be treated according to standard of care by the trauma team caring for the patient.
Urine Catecholamine Levels Baseline	236.4 microgram/L Standard Error 56.30	278.0 microgram/L Standard Error 52.1
Urine Catecholamine Levels Day 2	263.6 microgram/L Standard Error 51.56	181.9 microgram/L Standard Error 59.28
Urine Catecholamine Levels Day 5	308.5 microgram/L Standard Error 51.29	200.1 microgram/L Standard Error 48.19
Urine Catecholamine Levels Day 10	324.4 microgram/L Standard Error 51.67	216.7 microgram/L Standard Error 50.52
Urine Catecholamine Levels Day 14	375.3 microgram/L Standard Error 56.06	275.7 microgram/L Standard Error 44.06

Adverse Events

Propranolol Arm

Serious events: 0 serious events

Other events: 1 other events

Deaths: 1 deaths

Non Propranolol Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 4 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Propranolol Arm n=13 participants at risk One half of qualifying and consenting subjects will be randomized to receive propranolol. This group will receive study drug 3 times daily (every 8 hours) starting at 20 mg. The dosage may be increased by up to 60 mg/day divided over three daily doses (or an additional 20 mg/dose) as necessary until the heart rate is less than 100. Study drug will be held for hypotension (systolic \<100) or bradycardia (heart rate \<60 beats per minute). The maximum daily dose for the treatment of hypertension of 640 mg will not be exceeded in this study. Propranolol	Non Propranolol Arm n=12 participants at risk Non beta blockade arm will receive standard of care treatment and will not receive beta blockade. If a subject randomized to no Inderal develops hypertension and increased heart rate, he/she will be treated according to standard of care by the trauma team caring for the patient.
Cardiac disorders Tachycardia	7.7% 1/13 • Number of events 1 • 24 months	0.00% 0/12 • 24 months

Additional Information

Thomas J. Schroeppel, MD, MS

UCHealth

Phone: 719 365 2422

Email: thomas.schroeppel@uchealth.org

Results disclosure agreements

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