Ebola_CP

Phase 2

Recruiting

• Conditions: Ebola

• Registration Number: PACTR201602001355272
• Lead Sponsor: niversity of Liverpool

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-20
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 130

Inclusion Criteria

Any
 age
 
  - Pregnant
 women
 are
 permitted
 to
 enter
 the
 study
  - PCR-­¿confirmed,
 symptomatic
 infection
 with
 EV
  -­¿
  Ability
 for
 informed
 consent
 to
 participate
 in
 the
 study
 to
 be
 obtained:
 
 -­¿
 
  For
 adults
 (as
 defined
 by
 local
 regulations):
 written
 (signature
 or
 thumb
 print)
 by
 patient
 or
  culturally
 acceptable
 guardian
 if
 patient
 considered
 unable
 to
 fully
 comprehend
 and
 provide
  informed
 consent
  -­¿
 
  For
 younger
 ages
 (<18
 yrs
 old):
 consent
 by
 parent
 or
 culturally
 acceptable
 guardian

Exclusion Criteria

 
 History
 of
 allergic
 reaction
 to
 blood
 or
 plasma
 products
 (as
 judged
 by
 the
 investigator
 or
  treating
 doctor)
  -­¿
 
 
 
 
 
 Medical
 conditions
 in
 which
 receipt
 of
 450-­¿500ml
 volume
 or
 10ml/kg
 (for
 those
 weight
 <45kg)
  may
 be
 detrimental
 to
 the
 patient
 (e.g.
 decompensated
 congestive
 heart
 failure)
  -­¿
  Unresponsive
 on
 AVPU
 score
 (Alert,
 Voice
 Responsive,
 Pain
 Responsive,
 Unresponsive)
 just
 prior
  to
 intervention
 
 Futility:
 those
 patients
 with
 late
 presentation
 of
 EVD
 in
 whom
 treatment
 is
 considered
 too
  late
 to
 be
 effective,
 e.g.
 shock
 not
 responding
 to
 fluid
 challenge
 or
 severe
 haemorrhage
 
 Inability
 to
 cannulate
 a
 vein
 for
 any
 reason
 

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All-­¿cause  mortality  at  day  14  after  the  intervention

Secondary Outcome Measures

Name	Time	Method
30  day  all-­¿cause  mortality  after  the  intervention