NCT02866604

Brief Summary

The main objective of this study is to compare the clinical outcomes of TBI patients receiving only Sterofundin or 0.9% saline as main fluid therapy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

May 23, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 15, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

October 26, 2016

Status Verified

October 1, 2016

Enrollment Period

1.8 years

First QC Date

May 23, 2016

Last Update Submit

October 25, 2016

Conditions

Brain Injuries

Keywords

Traumatic brain injuryisotonic balanced fluid

Outcome Measures

Primary Outcomes (2)

  • 30 day mortality

    30 days

  • Functional neurological outcomes at 6 months based on Extended Glasgow Outcome Scale (GOS-E)

    180 days

Secondary Outcomes (7)

  • Acid-base balance

    3 days

  • Daily mean change in intracranial pressure (ICP)

    3 days

  • Episodes of intracranial hypertension

    3 days

  • Duration of mechanical ventilation

    3 days

  • Length of ICU stay

    30 days

  • +2 more secondary outcomes

Study Arms (2)

Strerofundin

ACTIVE COMPARATOR

Days of intervention: 3 days

Procedure: Sterofundin

0.9% saline

ACTIVE COMPARATOR

Days of intervention: 3 days

Procedure: 0.9% saline

Interventions

SterofundinPROCEDURE
Strerofundin
0.9% salinePROCEDURE
0.9% saline

Eligibility Criteria

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

You may qualify if:

  • Patients age between 18 and 65 years of age
  • Non-penetrating moderate (GCS 9-12) or severe (GCS 3-8) traumatic brain injury
  • Within 12 hours since the recorded time of injury

You may not qualify if:

  • Pregnancy
  • Polytrauma
  • Cardiac arrest at presentation
  • GCS of three with bilateral fixed dilated pupils,
  • Evidence of severe cardiac, respiratory, renal or liver dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Malaya Medical Centre

Petaling Jaya, Kuala Lumpur, 50603, Malaysia

Location

MeSH Terms

Conditions

Brain InjuriesBrain Injuries, Traumatic

Interventions

sterofundinSaline Solution

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Central Study Contacts

Sia S Fu, MSurg, PhD

CONTACT

+603-79492441sfsia02@um.edu.my

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2016

First Posted

August 15, 2016

Study Start

October 1, 2016

Primary Completion

August 1, 2018

Study Completion

February 1, 2019

Last Updated

October 26, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

MY(1)