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Beta Blockade in in Traumatic Brain Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02957331
Recruitment Status : Completed
First Posted : November 6, 2016
Results First Posted : June 4, 2020
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
University of Tennessee

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Brain Injuries, Traumatic
Intervention Drug: Propranolol
Enrollment 26
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Propranolol Arm Non Propranolol Arm
Hide Arm/Group Description

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 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.
Period Title: Overall Study
Started 14 12
Completed 13 12
Not Completed 1 0
Reason Not Completed
Protocol Violation             1             0
Arm/Group Title Propranolol Arm Non Propranolol Arm Total
Hide Arm/Group Description

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 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 of all reporting groups
Overall Number of Baseline Participants 13 12 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 12 participants 25 participants
49.7  (19.0) 53.0  (21.9) 51.3  (20.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 12 participants 25 participants
Female
4
  30.8%
5
  41.7%
9
  36.0%
Male
9
  69.2%
7
  58.3%
16
  64.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
1.Primary Outcome
Title Mortality
Hide Description Mortality will be assessed at day 30 or at hospital discharge
Time Frame 30 day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Propranolol Arm Non Propranolol Arm
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 13 12
Measure Type: Number
Unit of Measure: percentage of participants
7.7 33.3
2.Secondary Outcome
Title Urine Catecholamine Levels
Hide Description Urine catecholamine levels will be measured in the hospital laboratory
Time Frame Collected at baseline, Day 2, Day 5, Day 10 and Day 14.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Propranolol Arm Non Propranolol Arm
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 13 12
Least Squares Mean (Standard Error)
Unit of Measure: microgram/L
Baseline 236.4  (56.30) 278.0  (52.1)
Day 2 263.6  (51.56) 181.9  (59.28)
Day 5 308.5  (51.29) 200.1  (48.19)
Day 10 324.4  (51.67) 216.7  (50.52)
Day 14 375.3  (56.06) 275.7  (44.06)
Time Frame 24 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Propranolol Arm Non Propranolol Arm
Hide Arm/Group Description

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 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.
All-Cause Mortality
Propranolol Arm Non Propranolol Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   1/13 (7.69%)      4/12 (33.33%)    
Hide Serious Adverse Events
Propranolol Arm Non Propranolol Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/13 (0.00%)      0/12 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Propranolol Arm Non Propranolol Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/13 (7.69%)      0/12 (0.00%)    
Cardiac disorders     
Tachycardia  [1]  1/13 (7.69%)  1 0/12 (0.00%) 
Indicates events were collected by systematic assessment
[1]
Rebound tachycardia occurred when propranolol was tapered off. A slower taper was used and this resolved the event.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Thomas J. Schroeppel, MD, MS
Organization: UCHealth
Phone: 719 365 2422
EMail: thomas.schroeppel@uchealth.org
Publications:
Layout table for additonal information
Responsible Party: University of Tennessee
ClinicalTrials.gov Identifier: NCT02957331    
Other Study ID Numbers: IRB # 15-04069-FB
First Submitted: October 31, 2016
First Posted: November 6, 2016
Results First Submitted: July 23, 2019
Results First Posted: June 4, 2020
Last Update Posted: June 4, 2020