Narrative Review: Major Bleeding

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

 Event

Addmission date: MM/DD/YYYY

Demographic: [age] year old [gender]

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

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:

Date	Time	HGB	HTC	PLT	INR	PT/PTT
xx/xx/xxx	xx:xx
xx/xx/xxx	xx:xx
xx/xx/xxx	xx:xx

• • 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]