NCT02957331

Brief Summary

The purpose of this study is test the effect of beta-adrenergic blockade on mortality in patients with traumatic brain injury with the hypothesis being that the addition of beta blockade to the treatment regime of this patient population will lower mortality and supress the catecholamine surge that accompanies traumatic brain injury as compared to those who do not receive beta blockade. Half the patients will be randomized to receive propranolol and half will be randomized to receive no beta blocker.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2016

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 7, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

June 4, 2020

Completed
Last Updated

June 4, 2020

Status Verified

October 1, 2018

Enrollment Period

2.3 years

First QC Date

October 31, 2016

Results QC Date

July 23, 2019

Last Update Submit

June 1, 2020

Conditions

Brain Injuries, Traumatic

Outcome Measures

Primary Outcomes (1)

  • Mortality

    Mortality will be assessed at day 30 or at hospital discharge

    30 day

Secondary Outcomes (1)

  • Urine Catecholamine Levels

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

Study Arms (2)

Propranolol arm

EXPERIMENTAL

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.

Drug: Propranolol

Non propranolol arm

NO INTERVENTION

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.

Interventions

PropranololDRUG
Also known as: Inderal
Propranolol arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects ages 18 and older with isolated traumatic brain injury as defined by Glasgow Coma Scale score 12 or less with documented injury on head CT and limited injury to the rest of the body. (Abbreviated Injury Scale (AIS) must be \< or = 3 from other body areas.)

You may not qualify if:

  • Subjects \<18 years of age, prisoners, those on beta-blockers as home medication, those who are pregnant, those with severe liver disease, those taking vasopressors, those with acute coronary syndrome, and those with severe injury to another body region (AIS \>3).
  • Subjects who cannot be enrolled within 48 hours of admission following acute resuscitation will not be enrolled into this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Regional One Health

Memphis, Tennessee, 38103, United States

Location

Related Publications (15)

  • Kun LE, Gajjar A, Muhlbauer M, Heideman RL, Sanford R, Brenner M, Walter A, Langston J, Jenkins J, Facchini S. Stereotactic injection of herpes simplex thymidine kinase vector producer cells (PA317-G1Tk1SvNa.7) and intravenous ganciclovir for the treatment of progressive or recurrent primary supratentorial pediatric malignant brain tumors. Hum Gene Ther. 1995 Sep;6(9):1231-55. doi: 10.1089/hum.1995.6.9-1231.

    PMID: 8527482BACKGROUND

  • Pople IK, Sanford RA, Muhlbauer MS. Clinical presentation and management of 100 infants with occipital plagiocephaly. Pediatr Neurosurg. 1996 Jul;25(1):1-6. doi: 10.1159/000121088.

    PMID: 9055327BACKGROUND

  • Gajjar A, Sanford RA, Bhargava R, Heideman R, Walter A, Li Y, Langston JW, Jenkins JJ, Muhlbauer M, Boyett J, Kun LE. Medulloblastoma with brain stem involvement: the impact of gross total resection on outcome. Pediatr Neurosurg. 1996 Oct;25(4):182-7. doi: 10.1159/000121121.

    PMID: 9293545BACKGROUND

  • Aggarwal R, Yeung D, Kumar P, Muhlbauer M, Kun LE. Efficacy and feasibility of stereotactic radiosurgery in the primary management of unfavorable pediatric ependymoma. Radiother Oncol. 1997 Jun;43(3):269-73. doi: 10.1016/s0167-8140(97)01926-9.

    PMID: 9215786BACKGROUND

  • Chuba PJ, Aronin P, Bhambhani K, Eichenhorn M, Zamarano L, Cianci P, Muhlbauer M, Porter AT, Fontanesi J. Hyperbaric oxygen therapy for radiation-induced brain injury in children. Cancer. 1997 Nov 15;80(10):2005-12. doi: 10.1002/(sici)1097-0142(19971115)80:103.0.co;2-0.

    PMID: 9366305BACKGROUND

  • Gajjar A, Sanford RA, Heideman R, Jenkins JJ, Walter A, Li Y, Langston JW, Muhlbauer M, Boyett JM, Kun LE. Low-grade astrocytoma: a decade of experience at St. Jude Children's Research Hospital. J Clin Oncol. 1997 Aug;15(8):2792-9. doi: 10.1200/JCO.1997.15.8.2792.

    PMID: 9256121BACKGROUND

  • Muhlbauer M, Pfisterer W, Eyb R, Knosp E. Minimally invasive retroperitoneal approach for lumbar corpectomy and anterior reconstruction. Technical note. J Neurosurg. 2000 Jul;93(1 Suppl):161-7. doi: 10.3171/spi.2000.93.1.0161.

    PMID: 10879777BACKGROUND

  • Fletcher DT, Warner WC, Muhlbauer MS, Merchant TE. Cervical subluxation after surgery and irradiation of childhood ependymoma. Pediatr Neurosurg. 2002 Apr;36(4):189-96. doi: 10.1159/000056056.

    PMID: 12006754BACKGROUND

  • Williams RF, Magnotti LJ, Croce MA, Hargraves BB, Fischer PE, Schroeppel TJ, Zarzaur BL, Muhlbauer M, Timmons SD, Fabian TC. Impact of decompressive craniectomy on functional outcome after severe traumatic brain injury. J Trauma. 2009 Jun;66(6):1570-4; discussion 1574-6. doi: 10.1097/TA.0b013e3181a594c4.

    PMID: 19509616BACKGROUND

  • DiCocco JM, Fabian TC, Emmett KP, Magnotti LJ, Zarzaur BL, Bate BG, Muhlbauer MS, Khan N, Kelly JM, Williams JS, Croce MA. Optimal outcomes for patients with blunt cerebrovascular injury (BCVI): tailoring treatment to the lesion. J Am Coll Surg. 2011 Apr;212(4):549-57; discussion 557-9. doi: 10.1016/j.jamcollsurg.2010.12.035.

    PMID: 21463787BACKGROUND

  • Murphy RF, Cohen BH, Muhlbauer MS, Eubanks JW 3rd, Sawyer JR, Moisan A, Kelly DM. An accessory limb with lipomyelomeningocele in a male. Pediatr Surg Int. 2013 Jul;29(7):749-52. doi: 10.1007/s00383-013-3269-9. Epub 2013 Feb 8.

    PMID: 23392915BACKGROUND

  • Klimo P Jr, Astur N, Gabrick K, Warner WC Jr, Muhlbauer MS. Occipitocervical fusion using a contoured rod and wire construct in children: a reappraisal of a vintage technique. J Neurosurg Pediatr. 2013 Feb;11(2):160-9. doi: 10.3171/2012.9.PEDS12214. Epub 2012 Nov 16.

    PMID: 23157394BACKGROUND

  • Astur N, Klimo P Jr, Sawyer JR, Kelly DM, Muhlbauer MS, Warner WC Jr. Traumatic atlanto-occipital dislocation in children: evaluation, treatment, and outcomes. J Bone Joint Surg Am. 2013 Dec 18;95(24):e194(1-8). doi: 10.2106/JBJS.L.01295.

    PMID: 24352780BACKGROUND

  • Astur N, Sawyer JR, Klimo P Jr, Kelly DM, Muhlbauer M, Warner WC Jr. Traumatic atlanto-occipital dislocation in children. J Am Acad Orthop Surg. 2014 May;22(5):274-82. doi: 10.5435/JAAOS-22-05-274.

    PMID: 24788443BACKGROUND

  • Befeler AR, Gordon W, Khan N, Fernandez J, Muhlbauer MS, Sorenson JM. Results of delayed follow-up imaging in traumatic brain injury. J Neurosurg. 2016 Mar;124(3):703-9. doi: 10.3171/2015.4.JNS141257. Epub 2015 Oct 16.

    PMID: 26473787BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Propranolol

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Results Point of Contact

Title
Thomas J. Schroeppel, MD, MS
Organization
UCHealth
thomas.schroeppel@uchealth.org
719 365 2422

Study Officials

  • Thomas J. Schroeppel, MD

    University of Tennessee

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2016

First Posted

November 7, 2016

Study Start

January 1, 2016

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

June 4, 2020

Results First Posted

June 4, 2020

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)