Narrative Review: Major Bleeding: Difference between revisions

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(Created page with " '''Site:''' '''AE:''' '''Complication:''' '''Event date:''' '''Adverse event code:''' * '''Demograghic''': [age] year old [gender] * '''Past Medical History:''' [eg. VHD...")
 
 
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__NOTOC__
{{Narrative Review}}
{{CMG}}; {{AE}}{{MJ}}


'''Site:'''
{| class="wikitable"
 
!Site
'''AE:'''
!Patient
 
!AE
'''Complication:'''
!Complication
 
!Event date
'''Event date:'''
!AE code
|-
|xxx
|xxx
|x
|
|mm/dd/YYYY
|xxx
|}
== Diagnosis==
'''Addmission date:''' MM/DD/YYYY


'''Adverse event code:'''
* '''Demograghic''': [age] year old [gender]
* '''Past Medical History:''' [eg. VHD, anticoagulant usage, diabetes, and CAD,.../ including date]
* '''Past Surgical History:'''[including date]
* '''Index Procedure Date/Time''': xx/xx/xxxx at xx:xx  [insert date and time]
* '''Index Procedure Detail''': 
** On xx/xx/xxxx at xx:xx [insert date and time] the subject underwent a [select surgical correction] for [select etiology].
** Enter access site details
** The site reported that there were/were not procedural complication(s).
* '''Event''': MI
* '''Site Reported Event Onset Date:''' xx/xx/xxxx
* '''Event summary''':
** Symptoms and sign: Subject presented with [sign and symptom] on xx/xx/xxxx.
** Important characteristics of the chief complaint such as severity, site, and duration.
** Other important symptoms related to the chief compliant.
** Physical assessment: 
** Vital signs
** Positive physical examinations or related negative examinations.
* '''Lab studies:'''
** Bun/Cr levels
{| class="wikitable"
{| class="wikitable"
|'''Date'''
|'''Date'''
|'''Time'''
|'''Time'''
|'''BUN/Cr'''
|'''HgB'''
|'''Na/K'''
|'''HTC'''
|'''Urine output'''
|'''PLT'''
|'''INR'''
|'''PT/PTT'''
|'''Transfusion (Units/24hr)'''
|-
|-
|xx/xx/xxx
|xx/xx/xxx
|xx:xx
|xx:xx
|
|
|
|
|
|
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|xx/xx/xxx
|xx/xx/xxx
|xx:xx
|xx:xx
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|xx/xx/xxx
|xx/xx/xxx
|xx:xx
|xx:xx
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** Other labratory:
 
== Major Bleeding ==
An episode of suspected internal or external bleeding that results in one or more of the following:
 
O Death
 
O Re-operation
 
O Hospitalization
 
O Transfusion of red blood cells as follows:
 
==== During first 7 days post implant ====
* Adults (≥ 50 kg):  ≥ 4U packed red blood cells (PRBC) within any 24 hour period during first 7 days post implant.
 
==== After 7 days post implant ====
* Any transfusion of packed red blood cells (PRBC) after 7 days following implant with the investigator recording the number of units given. (record number of units given per 24 hour period).
Note: Hemorrhagic stroke is considered a neurological event and not as a separate bleeding event.
 
== Event ==
'''Demographic:''' [age] year old [gender]
 
'''Site Reported Event Onset Date:''' MM/DD/YYYY
 
'''Event summary''':
*'''Symptoms and sign''':
**Subject presented with [sign and symptom] on MM/DD/YYYY.
**Important characteristics of the chief complaint such as severity, site, and duration.
**Other important symptoms related to the chief complaint.
 
*'''Past Medical History:''' [eg. CAD, Severe mitral stenosis, former tobacco use, dyslipidemia, ...]
*'''Past Surgical History:''' [including date]
*'''Medications:''' [relevant to the event not all]
*'''Physical assessment:'''
**Vital signs
**Positive physical examinations or related negative examinations.
'''Event (2): [If there is more than 1 event]'''
 
==Procedure==
*'''Index Procedure Date/Time''':
**mm/dd/YYYY at xx:xx  [insert date and time]
*'''Index Procedure Detail''':
**On mm/dd/YYYY at xx:xx [insert date and time] the subject underwent a [select surgical correction] for [select etiology].
**Access site details
**The site reported that there were/were not procedural complication(s). 
 
== Laboratory data and Imaging ==
* '''Lab studies:'''
** CBC, INR, and PT/PTT:
** Other relevant laboratory tests:
*** Date/ name/ value
*** Date/ name/ value


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* '''CXR / date:'''  
* '''CXR / date:'''  
* '''Other imaging and diagnostic tests / date:'''
* '''Other imaging and diagnostic tests / date:'''
* '''Consults:'''
** Date / result:
* '''Clinical course''':
* '''Dialysis:'''
*# xx/xx/xxxx at xx:xx 
*# xx/xx/xxxx at xx:xx 
*# xx/xx/xxxx at xx:xx 
*# xx/xx/xxxx at xx:xx 


* '''Treatment / date:'''
==Consults==
* '''Outcome:''' [Discharge / Hospice / Death]
*Date and time of consult
*Suggested treatments
==Clinical course==
*Date and time of events,
*Patient condition got worse or better.
==Treatment and outcome==
*List of relevant medical treatments
*Outcome [Discharge / Hospice / Death]

Latest revision as of 01:00, 27 June 2018

Narrative Review

Narrative Review: Death

Narrative Review: Stroke

Narrative Review: Myocardial Infarction

Narrative Review: Acute Kidney Injury

Narrative Review: Bleeding

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Mehrian Jafarizade, M.D [2]

Site Patient AE Complication Event date AE code
xxx xxx x mm/dd/YYYY xxx

 Diagnosis

Addmission date: MM/DD/YYYY

Date Time HgB HTC PLT INR PT/PTT Transfusion (Units/24hr)
xx/xx/xxx xx:xx
xx/xx/xxx xx:xx
xx/xx/xxx xx:xx

Major Bleeding

An episode of suspected internal or external bleeding that results in one or more of the following:

O Death

O Re-operation

O Hospitalization

O Transfusion of red blood cells as follows:

During first 7 days post implant

  • Adults (≥ 50 kg):  ≥ 4U packed red blood cells (PRBC) within any 24 hour period during first 7 days post implant.

After 7 days post implant

  • Any transfusion of packed red blood cells (PRBC) after 7 days following implant with the investigator recording the number of units given. (record number of units given per 24 hour period).

Note: Hemorrhagic stroke is considered a neurological event and not as a separate bleeding event.

Event

Demographic: [age] year old [gender]

Site Reported Event Onset Date: MM/DD/YYYY

Event summary:

  • Symptoms and sign:
    • Subject presented with [sign and symptom] on MM/DD/YYYY.
    • Important characteristics of the chief complaint such as severity, site, and duration.
    • Other important symptoms related to the chief complaint.
  • Past Medical History: [eg. CAD, Severe mitral stenosis, former tobacco use, dyslipidemia, ...]
  • Past Surgical History: [including date]
  • Medications: [relevant to the event not all]
  • Physical assessment:
    • Vital signs
    • Positive physical examinations or related negative examinations.

Event (2): [If there is more than 1 event]

Procedure

  • Index Procedure Date/Time:
    • mm/dd/YYYY at xx:xx [insert date and time]
  • Index Procedure Detail:
    • On mm/dd/YYYY at xx:xx [insert date and time] the subject underwent a [select surgical correction] for [select etiology].
    • Access site details
    • The site reported that there were/were not procedural complication(s). 

Laboratory data and Imaging

  • Lab studies:
    • CBC, INR, and PT/PTT:
    • Other relevant laboratory tests:
      • Date/ name/ value
  • ECG / date:
  • ECHO / date:
  • CXR / date:
  • Other imaging and diagnostic tests / date:

Consults

  • Date and time of consult
  • Suggested treatments

Clinical course

  • Date and time of events,
  • Patient condition got worse or better.

Treatment and outcome

  • List of relevant medical treatments
  • Outcome [Discharge / Hospice / Death]
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