Ignite Creation Date:
2024-05-06 @ 2:59 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04484233
Status:
UNKNOWN
Last Update Posted:
2020-07-23
First Post:
2020-07-18
Brief Title:
Evaluation of a Clinical Decision Support System for Anemia Management in Pre-operative Care
Sponsor:
Intelligence Anesthesia
Organization:
Intelligence Anesthesia
Study Overview
Official Title:
Evaluation of a Clinical Decision Support System for Anemia Management in Pre-operative Care Feasibility Validation Study
Status:
UNKNOWN
Status Verified Date:
2020-07
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
iAnemia
Brief Summary:
Anemia need to be diagnosed and treated following several guidelines However the complexity of these recommendations leads to low compliance and to unnecessary and harmful per- and postoperative blood transfusion
In order to improve practices and regarding the complexity of the guidelines the latest European Consensus Conference recommends the use of decision support systems for the management of preoperative anemia
In order to improve practices and regarding the complexity of the guidelines the latest European Consensus Conference recommends the use of decision support systems for the management of preoperative anemia
Detailed Description:
The World Health Organization defines anemia as a hemoglobin level of less than 13 gdL in adult men and less than 12 gdL in women
The cause of these anemias is most often deficient with 17 iron deficiency This deficiency is related to age inflammatory diseases blood loss and absorption disorders mainly Anemia must be diagnosed preoperatively and treated
To reduce transfusion in the perioperative period there are various possibilities increase of the preoperative erythrocyte mass reduction of losses use of the blood that has been applied
The impact of these preoperative strategies can be considerable In their work Beattie and al demonstrates that transfusion is associated with an increase in mortality at 90 days proportional to the volume transfused with certainly a higher risk in fragile subjects More recently an American registry of more than 220000 patients showed that 30 had preoperative anemia This anemia not only significantly increased mortality but all causes of comorbidity were aggravated in an anemic patient
However the complexity of these recommendations leads to low compliance and to unnecessary and harmful per- and postoperative blood transfusion
In order to improve practices and regarding the complexity of the guidelines the latest European Consensus Conference recommends the use of decision support systems for the management of preoperative anemia
The cause of these anemias is most often deficient with 17 iron deficiency This deficiency is related to age inflammatory diseases blood loss and absorption disorders mainly Anemia must be diagnosed preoperatively and treated
To reduce transfusion in the perioperative period there are various possibilities increase of the preoperative erythrocyte mass reduction of losses use of the blood that has been applied
The impact of these preoperative strategies can be considerable In their work Beattie and al demonstrates that transfusion is associated with an increase in mortality at 90 days proportional to the volume transfused with certainly a higher risk in fragile subjects More recently an American registry of more than 220000 patients showed that 30 had preoperative anemia This anemia not only significantly increased mortality but all causes of comorbidity were aggravated in an anemic patient
However the complexity of these recommendations leads to low compliance and to unnecessary and harmful per- and postoperative blood transfusion
In order to improve practices and regarding the complexity of the guidelines the latest European Consensus Conference recommends the use of decision support systems for the management of preoperative anemia
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None