Narrative Review: Major Bleeding
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Editor-In-Chief: C. Michael Gibson, M.S., M.D. ; Associate Editor(s)-in-Chief: Mehrian Jafarizade, M.D 
|Site||Patient||AE||Complication||Event date||AE code|
Addmission date: MM/DD/YYYY
An episode of suspected internal or external bleeding that results in one or more of the following:
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
- 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
- Date and time of events,
- Patient condition got worse or better.
Treatment and outcome
- List of relevant medical treatments
- Outcome [Discharge / Hospice / Death]