Ignite Creation Date:
2024-05-06 @ 12:32 AM
Last Modification Date:
2024-10-26 @ 10:51 AM
Study NCT ID:
NCT01597232
Status:
COMPLETED
Last Update Posted:
2019-11-20
First Post:
2012-05-09
Brief Title:
Clinic Trial for West China Perioperative Transfusion Score WCPTS
Sponsor:
West China Hospital
Organization:
West China Hospital
Study Overview
Official Title:
Effect of West China Perioperative Transfusion Score WCPTS on Red Blood Cells Transfusion in Patients Undergoing Major Surgery a Prospective Multicenter Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2019-11
Last Known Status:
None
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 610gdL is based on the judgment from anesthesiologists or surgeons Index of transfusion trigger for patients with hemoglobin level between 6gdL 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 6gdL and 10gdL could be calculated by parameters including infusion rate of adrenalin for maintaining normal cardiac output fraction of inspired oxygen core temperature and angina 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
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 6gdL and 10gdL could be calculated by parameters including infusion rate of adrenalin for maintaining normal cardiac output fraction of inspired oxygen core temperature and angina 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 TRALI 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 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 610gdL is based on the judgment from anesthesiologists or surgeons Index of transfusion trigger for patients with hemoglobin level between 6gdL 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 6gdL and 10gdL could be calculated by parameters including infusion rate of adrenalin for maintaining normal cardiac output fraction of inspired oxygen for maintaining spO295 core temperature and angina
Peri-Operative Transfusion Trigger Score POTTS The initial score is 6 If a patients cardiac output is normal without infusion of adrenalin his spO2 could be maintained more than 95 with FiO235 his core temperature is less than 38 and he has no angina his score is 6
If a patient has one or more problems including his normal cardiac output should be maintained by infusion of adrenalin with its rate 005μgkgmin or his spO2 is maintained more than 95 with 3650 FiO2 or his core temperature is between 38 to 40 or chest pain due to exercisemanual laboror excitement his score should be added 1 point for each problem
If a patient has one or more problems including his normal cardiac output should be maintained by infusion of adrenalin with its rate 006μgkgmin or his spO2 is maintained more than 95 with 51 FiO2 or his core temperature is 40 or sudden onset of chest pain at rest his score should be added 2 point for each problem
The initial POTTS score is 6 and the patients score is calculated by the sum of each item
Score 6The transfusion trigger is 6gdL and the the patients Hemoglobin level should be maintained not less than 6gdL
Score 7The transfusion trigger is 7gdL and the the patients Hemoglobin level should be maintained not less than 7gdL
Score 8The transfusion trigger is 8gdL and the the patients Hemoglobin level should be maintained not less than 8gdL
Score 9The transfusion trigger is 9gdL and the the patients Hemoglobin level should be maintained not less than 9gdL
Score 10 or 10The transfusion trigger is 10gdL and the the patients Hemoglobin level should be maintained not less than 10gdL
For example if a patient need 005μgkgmin adrenalin to maintain his normal cardiac output 1 his spO2 could be maintained more than 95 with FiO235 his core temperature is less than 38 and he has sudden onset of chest pain at rest 2 his POTTS score could be calculated as 6 1 005μgkgmin adrenalin to maintain his normal cardiac output 2 sudden onset of chest pain at rest and his POTTS score is 9 That means this patients transfusion trigger is 9gdL and his hemoglobin level should be maintained above 9 at this situation
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 610gdL is based on the judgment from anesthesiologists or surgeons Index of transfusion trigger for patients with hemoglobin level between 6gdL 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 6gdL and 10gdL could be calculated by parameters including infusion rate of adrenalin for maintaining normal cardiac output fraction of inspired oxygen for maintaining spO295 core temperature and angina
Peri-Operative Transfusion Trigger Score POTTS The initial score is 6 If a patients cardiac output is normal without infusion of adrenalin his spO2 could be maintained more than 95 with FiO235 his core temperature is less than 38 and he has no angina his score is 6
If a patient has one or more problems including his normal cardiac output should be maintained by infusion of adrenalin with its rate 005μgkgmin or his spO2 is maintained more than 95 with 3650 FiO2 or his core temperature is between 38 to 40 or chest pain due to exercisemanual laboror excitement his score should be added 1 point for each problem
If a patient has one or more problems including his normal cardiac output should be maintained by infusion of adrenalin with its rate 006μgkgmin or his spO2 is maintained more than 95 with 51 FiO2 or his core temperature is 40 or sudden onset of chest pain at rest his score should be added 2 point for each problem
The initial POTTS score is 6 and the patients score is calculated by the sum of each item
Score 6The transfusion trigger is 6gdL and the the patients Hemoglobin level should be maintained not less than 6gdL
Score 7The transfusion trigger is 7gdL and the the patients Hemoglobin level should be maintained not less than 7gdL
Score 8The transfusion trigger is 8gdL and the the patients Hemoglobin level should be maintained not less than 8gdL
Score 9The transfusion trigger is 9gdL and the the patients Hemoglobin level should be maintained not less than 9gdL
Score 10 or 10The transfusion trigger is 10gdL and the the patients Hemoglobin level should be maintained not less than 10gdL
For example if a patient need 005μgkgmin adrenalin to maintain his normal cardiac output 1 his spO2 could be maintained more than 95 with FiO235 his core temperature is less than 38 and he has sudden onset of chest pain at rest 2 his POTTS score could be calculated as 6 1 005μgkgmin adrenalin to maintain his normal cardiac output 2 sudden onset of chest pain at rest and his POTTS score is 9 That means this patients transfusion trigger is 9gdL and his hemoglobin level should be maintained above 9 at this situation
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