Narrative Review: Major Bleeding

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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


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.


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]


  • 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:


  • 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]