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

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xxx  | xxx  | x  |  | mm/dd/YYYY  | xxx

##  Diagnosis

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Addmission date: MM/DD/YYYY

Date | Time | HgB | HTC | PLT | INR | PT/PTT | Transfusion (Units/24hr)

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xx/xx/xxx  | xx:xx  |  |  |  |  |  |
xx/xx/xxx  | xx:xx  |  |  |  |  |  |
xx/xx/xxx  | xx:xx  |  |  |  |  |  |

## Major Bleeding

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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

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* 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

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* 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

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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

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* 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

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* 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

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* Date and time of consult
* Suggested treatments

## Clinical course

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

## Treatment and outcome

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