Ignite Creation Date:
2024-05-05 @ 11:31 PM
Last Modification Date:
2024-10-26 @ 10:34 AM
Study NCT ID:
NCT01345643
Status:
COMPLETED
Last Update Posted:
2024-05-07
First Post:
2011-04-26
Brief Title:
Clinical Trial of West-China Perioperative Transfusion Score WCPTSfor Massive Hemorrhagic Surgery
Sponsor:
Ren Liao
Organization:
West China Hospital
Study Overview
Official Title:
A Randomized Controlled Clinical Trial of Transfusion Under the Guidance of West-China Perioperative Transfusion ScoreWCPTSfor Massive Hemorrhagic Surgery
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
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:
WCPTS
Brief Summary:
Guidelines for blood transfusion have been issued for years According to these guidelines red blood cells RBCs transfusion should be given when the hemoglobin level is less than 6gdL or 7gdL and is unnecessary when the level is more than 10gdL However in all the guidelines the determination of whether RBCs should be administered when the hemoglobin level is in the range of 710gdL is based on the judgment from anesthesiologists or surgeons Index of transfusion trigger for patients with hemoglobin level between 7dL and 10gdL is necessary and important in clinical practice Based on the aim of blood transfusion that maintain the balance of oxygen supply and oxygen consumption the investigators hypothesize that index of transfusion trigger for patients with hemoglobin level between 7dL and 10gdL could be calculated by their history about heart and blood pressure and routine monitoring parameters including pulse oximetry temperature and the use of vasoactive medications To verify this hypothesis the investigators present West China Perioperative Transfusion Score WCPTS for the trigger of transfusion according to the patients history and monitoring parameters and the investigators design a randomized controlled clinical trial to test this score
Detailed Description:
Surgery and trauma are the most common reasons for major blood loss and blood transfusion provide guarantee for massive hemorrhagic surgery especially orthopedic cardiac liver and gynecologic procedures On the other hand blood transfusion is associated with many risks including hemolytic and nonhemolytic reactions transfusion related acute lung injury and others Besides blood is insufficient worldwide How to eliminate allogeneic blood transfusion is an important part in clinical practice
Guidelines for blood transfusion have been issued by many health institutions or organizations in different countries According to these guidelines red blood cells RBCs transfusion should be given when the hemoglobin level is less than 6gdL or 7gdL and is unnecessary when the level is more than 10gdL However in all the guidelines the determination of whether RBCs should be administered when the hemoglobin level is in the range of 710gdL is based on the judgment from anesthesiologists or surgeons on the patients condition including intravascular volume status ongoing bleeding any risk factors for vital organs ischemia or hypoxia and so on Index of transfusion trigger for patients with hemoglobin level between 7dL and 10gdL is necessary and important in clinical practice
The aim of blood transfusion is to provide sufficient oxygen for the whole body and to maintain the balance of oxygen supply and oxygen consumption Factors associated with oxygen supply are hemoglobin level cardiac output CO and oxygen saturation Oxygen consumption is increased by the increase of metabolism which could be reflected by increase of heart rate blood pressure and body temperature If a patients oxygen supply is decreased or oxygen consumption is increased he will need a higher hemoglobin level to maintain the balance Based on these findings the investigators hypothesize that index of transfusion trigger for patients with hemoglobin level between 7dL and 10gdL could be calculated by their CO reflected by the use of adrenalin and routine monitoring parameters including pulse oximetry and core temperature
West China Perioperative Transfusion Score WCPTS
The initial score is 7
If a patients cardiac output CO is normal without continuous infusion of adrenalin or his SpO2 is more than 95 or his core temperature is less than 38 he doesnt have any bonus point factor and his score is 7
If a patients CO is maintained in normal range by continuous adrenalin infusion with concentration of less than 005μgkgmin or his SpO2 is 8594 or his core temperature is 3840 his score should be added 1 point for every item mentioned above
If a patients CO is only maintained by continuous adrenalin infusion with concentration of more than 005μgkgmin or his SpO2 is less than 84 or his core temperature is above 40 his score should be added 2 points for every item mentioned above
For example if a patients CO is normal his SpO2 is more than 95 and his core temperature is 39his WCPTS should be calcultaed as 7 plus 1 core temperature is 39 and his final score is 8
Heres another example if a patients CO is normal his core temperature is less than 38 but he has COPD and his SpO2 is less than 84 his score could be calculated as 7 plus 2SpO2 is less than 84 and his final score is 9
Value of SaO2 is evaluated 5min after endotracheal intubation with inhalation of compressive air
The initial score is 7and the patients score is calculated by 7 plus the sum of every item
Score 7To maintain the patients Hb level not less than 7gdL
Score 8To maintain the patients Hb level not less than 8gdL
Score 9To maintain the patients Hb level not less than 9gdL
Score 10 or 10To maintain the patients Hb level not less than 10gdL
Guidelines for blood transfusion have been issued by many health institutions or organizations in different countries According to these guidelines red blood cells RBCs transfusion should be given when the hemoglobin level is less than 6gdL or 7gdL and is unnecessary when the level is more than 10gdL However in all the guidelines the determination of whether RBCs should be administered when the hemoglobin level is in the range of 710gdL is based on the judgment from anesthesiologists or surgeons on the patients condition including intravascular volume status ongoing bleeding any risk factors for vital organs ischemia or hypoxia and so on Index of transfusion trigger for patients with hemoglobin level between 7dL and 10gdL is necessary and important in clinical practice
The aim of blood transfusion is to provide sufficient oxygen for the whole body and to maintain the balance of oxygen supply and oxygen consumption Factors associated with oxygen supply are hemoglobin level cardiac output CO and oxygen saturation Oxygen consumption is increased by the increase of metabolism which could be reflected by increase of heart rate blood pressure and body temperature If a patients oxygen supply is decreased or oxygen consumption is increased he will need a higher hemoglobin level to maintain the balance Based on these findings the investigators hypothesize that index of transfusion trigger for patients with hemoglobin level between 7dL and 10gdL could be calculated by their CO reflected by the use of adrenalin and routine monitoring parameters including pulse oximetry and core temperature
West China Perioperative Transfusion Score WCPTS
The initial score is 7
If a patients cardiac output CO is normal without continuous infusion of adrenalin or his SpO2 is more than 95 or his core temperature is less than 38 he doesnt have any bonus point factor and his score is 7
If a patients CO is maintained in normal range by continuous adrenalin infusion with concentration of less than 005μgkgmin or his SpO2 is 8594 or his core temperature is 3840 his score should be added 1 point for every item mentioned above
If a patients CO is only maintained by continuous adrenalin infusion with concentration of more than 005μgkgmin or his SpO2 is less than 84 or his core temperature is above 40 his score should be added 2 points for every item mentioned above
For example if a patients CO is normal his SpO2 is more than 95 and his core temperature is 39his WCPTS should be calcultaed as 7 plus 1 core temperature is 39 and his final score is 8
Heres another example if a patients CO is normal his core temperature is less than 38 but he has COPD and his SpO2 is less than 84 his score could be calculated as 7 plus 2SpO2 is less than 84 and his final score is 9
Value of SaO2 is evaluated 5min after endotracheal intubation with inhalation of compressive air
The initial score is 7and the patients score is calculated by 7 plus the sum of every item
Score 7To maintain the patients Hb level not less than 7gdL
Score 8To maintain the patients Hb level not less than 8gdL
Score 9To maintain the patients Hb level not less than 9gdL
Score 10 or 10To maintain the patients Hb level not less than 10gdL
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None