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Trial record 2 of 316 for:    Recruiting, Not yet recruiting, Available Studies | "Brain Injuries, Traumatic"

Pre-hospital Administration of Tranexamic Acid for Moderate and Severe Traumatic Brain Injury

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ClinicalTrials.gov Identifier: NCT02645552
Recruitment Status : Not yet recruiting
First Posted : January 1, 2016
Last Update Posted : January 1, 2016
Sponsor:
Collaborator:
Shanghai Pudong Emergency Center
Information provided by (Responsible Party):
Guoyi Gao, RenJi Hospital

Brief Summary:
This study is a prospective single-centre randomized trial to compare the effect of tranexamic acid versus placebo in the pre-hospital management of patients with moderate and severe traumatic brain injury.

Condition or disease Intervention/treatment Phase
Brain Injuries, Traumatic Drug: Tranexamic Acid Other: Sodium chloride Phase 3

Detailed Description:

Traumatic brain injury (TBI) remains a significant public health concern with poor outcome and one of the unmet needs in medical care. Tranexamic acid (TXA) has been shown to reduce blood loss after elective surgery and improve outcomes after traumatic injury due to bleeding without obvious adverse events. In the CRASH-2 Intracranial Bleeding Study, with the nested randomized trial design, the study showed that treatment with TXA within 8 hours of injury was associated with a reduction in haemorrhage growth [adjusted difference, -3.8 ml, 95% confidence interval (CI), -11.5 ml to 3.9 ml], fewer focal ischaemic lesions [adjusted odds ratio (OR) 0.54, 95% CI 0.20 to 1.46] and fewer death (adjusted OR 0.49, 95% CI 0.22 to 1.06) for patients with TBI (Glasgow coma score ≤ 14). The study also provided direction for future research of TXA in TBI, especially for the patients with moderate and severe TBI in whom an intracranial intracranial bleed (defined as the presence of parenchymal, subdural or epidural haemorrhage) is common.

Furtherly, results of the CRASH-2 trial stressed the importance of early adminstration with TXA for trauma patients, with the evidence showing that treatment of TXA within 1 hour post injury could significantly reduce the risk of death, while the benefit did not exist when TXA was administered more than 3 hours after injury. If the use of TXA could be incorporated into the pre-hospital management of TBI, the outcome of traumatically injured patients would be improved in an early stage. Thus, our study sets out to employ a randomized controlled study design, with a sample of 400 patients, to evaluate the efficacy and safety of early use of TXA in the pre-hospital management for moderate and severe TBI.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Pre-hospital Administration of Tranexamic Acid for Adults With Moderate and Severe Traumatic Brain Injury: a Randomized, Double-blinded, Placebo-controlled Trial
Study Start Date : January 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Tranexamic acid
Focused intervention
Drug: Tranexamic Acid
Tranexamic acid 1 gram in 100 ml saline, by intravenous drip over 10 minutes, once patient admitted to the trial on the spot of TBI
Other Name: Transamin
Placebo Comparator: Sodium chloride
Placebo control
Other: Sodium chloride
Sodium Chloride solution (0.9%) 1 ml (gram) in 100 ml saline, by intravenous drip over 10 minutes, once patient admitted to the trial on the spot of TBI
Other Name: Placebo



Primary Outcome Measures :
  1. Glasgow Outcome Scale (GOS) [ Time Frame: 6 months post injury ]
    The GOS is five-category scale used for assessing the neurologic outcome after brain injury as follows: 1, death; 2, vegetative state — unable to interact with the environment; 3, severe disability — unable to live independently but able to follow commands; 4, moderate disability — capable of living independently but unable to return to work or school; and 5, good recovery — able to return to work or school. In our statistical analyses, the outcome will be further dichotomized in unfavorable (GOS 1-3) vs favorable (GOS 4-5); the proportion of unfavorable outcome will be compared between groups.


Secondary Outcome Measures :
  1. Vascular occlusive events [ Time Frame: 6 months post injury ]
    Vascular occlusive events includes myocardial infarction, stroke, pulmonary embolism, clinical evidence of deep vein thrombosis.

  2. Death [ Time Frame: 6 months post injury ]
  3. Length of intensive care unit stay [ Time Frame: 6 months post injury ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • moderate to severe injuries(post-resuscitation scores Glasgow coma score of 4-12)
  • age >= 18 year
  • non-penetrating TBI in 2 hours onset

Exclusion Criteria:

  • patients with coagulopathy
  • pregnancy
  • receiving any medication which affects haemostasis
  • no consenting form

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02645552


Contacts
Contact: Junfeng Feng, MD, PhD 86-21-68383707 fengjfmail@163.com
Contact: Yanqing Ni, MD 86-13601602411 pd120xz@126.com

Locations
China, Shanghai
Department of Neurosurgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University Not yet recruiting
Shanghai, Shanghai, China, 200127
Contact: Junfeng Feng, MD, PhD    86-21-68383707    fengjfmail@163.com   
Contact: Yanqing Ni, MD    86-21-68383707    pd120xz@126.com   
Principal Investigator: Guoyi Gao, MD, PhD         
Principal Investigator: Yanqing Ni, MD         
Sub-Investigator: Qing Mao, MD, PhD         
Sub-Investigator: Junfeng Feng, MD, PhD         
Sub-Investigator: Jijun Sheng, MD         
Sub-Investigator: Hua Jiang, MD         
Sub-Investigator: Junlai Gu, MD         
Sub-Investigator: Jinghong Yang, MD         
Sub-Investigator: Xianghui Lu, MD         
Sub-Investigator: Xianfeng Qin, MD         
Sub-Investigator: Zhiguo Wang, MD         
Sub-Investigator: Jingde Xu, MD         
Sub-Investigator: Hongguan Wang, MD         
Sub-Investigator: Aiqun Cao, MD         
Sub-Investigator: Cao Wang, MD         
Sub-Investigator: Kaizhi Wang, MD         
Sponsors and Collaborators
RenJi Hospital
Shanghai Pudong Emergency Center
Investigators
Principal Investigator: Guoyi Gao, MD, PhD Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

Publications of Results:
Responsible Party: Guoyi Gao, Professor, RenJi Hospital
ClinicalTrials.gov Identifier: NCT02645552     History of Changes
Other Study ID Numbers: TXA4TBI
First Posted: January 1, 2016    Key Record Dates
Last Update Posted: January 1, 2016
Last Verified: December 2015

Keywords provided by Guoyi Gao, RenJi Hospital:
Traumatic brain injury

Additional relevant MeSH terms:
Brain Injuries, Traumatic
Wounds and Injuries
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants