Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06459141
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-05-26
Brief Title:
The Effect of Hemodilution on Intraoperative Allogeneic Transfusion HEAL
Sponsor:
Second Affiliated Hospital School of Medicine Zhejiang University
Organization:
Second Affiliated Hospital School of Medicine Zhejiang University
Study Overview
Official Title:
The Effect of Acute Normovolemic Hemodilution on Intraoperative Allogeneic Transfusion in Bone Tumor Surgery a Prospective Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-05
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:
None
Brief Summary:
The prevention of intraoperative allogenetic blood transfusion has the potential to reduce complications hospital stays and long-term prognosis in patients undergoing bone tumor surgery Data from previous studies suggest that the clinical efficacy of acute normovolemic hemodilution ANH has always been controversial and intraoperative fluid administration strategy is an important confounding factor The HEAL trial will assess whether ANH will reduce the volume of intraoperative allogeneic red blood cell transfusion when applying goal-directed fluid therapy in patients undergoing bone tumor surgery
Detailed Description:
Bone tumor surgery is associated with a significant risk of perioperative blood loss and transfusion with blood loss usually in the range of approximately 500-1000 ml and an average transfusion of up to 2 units of allogeneic red blood cell The increase in allogeneic blood transfusion volume is an independent risk factor for postoperative complications in patients undergoing bone tumor surgery as well as affecting the long-term survival rate of cancer patients
Acute normovolemic hemodilution ANH is a patient blood management measure The clinical efficacy of acute normovolemic hemodilution ANH has always been controversial and intraoperative fluid administration strategy is an important confounding factor As goal-directed fluid therapy GDFT is increasingly used in clinical practice it is of great importance to explore the efficacy of ANH in patients undergoing fluid management using GDFT
Bone tumor surgery is an ideal setting to evaluate ANH in GDFT as the procedure is associated with high blood loss and infusion The Hemodilution on Intraoperative Allogeneic Transfusion HEAL trial has been designed as a randomized controlled trial to determine whether ANH will reduce the volume of intraoperative allogeneic red blood cell transfusion when applying GDFT in patients undergoing bone tumor surgery
Acute normovolemic hemodilution ANH is a patient blood management measure The clinical efficacy of acute normovolemic hemodilution ANH has always been controversial and intraoperative fluid administration strategy is an important confounding factor As goal-directed fluid therapy GDFT is increasingly used in clinical practice it is of great importance to explore the efficacy of ANH in patients undergoing fluid management using GDFT
Bone tumor surgery is an ideal setting to evaluate ANH in GDFT as the procedure is associated with high blood loss and infusion The Hemodilution on Intraoperative Allogeneic Transfusion HEAL trial has been designed as a randomized controlled trial to determine whether ANH will reduce the volume of intraoperative allogeneic red blood cell transfusion when applying GDFT in patients undergoing bone tumor surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None