UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010294
Receipt number R000012050
Scientific Title Efficacy and safety of early fibrinogen concentrate substitution therapy for severe trauma patients receiving massive transfusions: prospective single arm clinical trial
Date of disclosure of the study information 2013/04/01
Last modified on 2018/09/10 23:09:04

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Basic information

Public title

Efficacy and safety of early fibrinogen concentrate substitution therapy for severe trauma patients receiving massive transfusions: prospective single arm clinical trial

Acronym

Pilot study of early fibrinogen concentrate substitution therapy for severe trauma patients

Scientific Title

Efficacy and safety of early fibrinogen concentrate substitution therapy for severe trauma patients receiving massive transfusions: prospective single arm clinical trial

Scientific Title:Acronym

Pilot study of early fibrinogen concentrate substitution therapy for severe trauma patients

Region

Japan


Condition

Condition

severe trauma

Classification by specialty

Surgery in general Orthopedics Neurosurgery
Emergency medicine Blood transfusion Intensive care medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To decide adequate dose of early fibrinogen concentrate substitution therapy for severe trauma patients receiving massive transfusions

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

the amount of blood transfusion for 24 hours after the hospital arriving
mortality for 72 hours after the hospital arriving
morbidity of venous thromboembolism during the hospital stay

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

freeze-dried human fibrinogen
Fibrinogen HT i.v. 1g - BENESIS
only the receiving injury day
dosage 2g or 3g/time
maximum of two times
Hemorrhagic trauma patients, whose serum fibrinogen concentration on admission is lower than 150mg/dl, are included in the trial. Freeze-dried human fibrinogen concentrate is administered once or twice within 24 hours of the injury. If the initial concentration is higher than 100mg/dl, 2g of the Fibrinogen is administered, else 3g is administered. Following the administration, the concentration is measured again. If the measurement is still lower than 150mg/dl, the second dose of Fibrinogen is administered according to the same criteria used to determine the initial dose. The concentration is measured again following the second administration.

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

12 years-old <=

Age-upper limit

80 years-old >

Gender

Male and Female

Key inclusion criteria

arrive at hospital within 3 hours after accident
shock or pre-shock
serum fibrinogen <=150mg/dl

Key exclusion criteria

(1)history of venous thromboembolism
(2)thrombotic diathesis (such as antithrombin deficiency,Protein S/C deficiency,antiphospholipid antibody syndrome)
(3)Agreement acquisition is impossible from the patient and the family.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Koichi Inokuchi

Organization

Saitama Medical Center, Saitama Medical University

Division name

Department of Emergency and Critical Care Medicine

Zip code


Address

Kawagoe-shi Kamoda 1981, JAPAN

TEL

0492283597

Email

inok_k@saitama-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Koichi Inokuchi

Organization

Saitama Medical Center, Saitama Medical University

Division name

Department of Emergency and Critical Care Medicine

Zip code


Address

Kawagoe-shi Kamoda 1981, JAPAN

TEL

0492283597

Homepage URL


Email

inok_k@saitama-med.ac.jp


Sponsor or person

Institute

Saitama Medical Center, Saitama Medical University

Institute

Department

Personal name



Funding Source

Organization

Saitama Medical Center, Saitama Medical University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

埼玉医科大学総合医療センター (埼玉県)


Other administrative information

Date of disclosure of the study information

2013 Year 04 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Open public recruiting

Date of protocol fixation

2013 Year 03 Month 05 Day

Date of IRB


Anticipated trial start date

2013 Year 05 Month 17 Day

Last follow-up date

2014 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 03 Month 22 Day

Last modified on

2018 Year 09 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012050


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name