The Effect of Hemodilution on Intraoperative Allogeneic Transfusion (HEAL)
NCT Number: NCT06459141
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Acute Normovolemic Hemodilution|Bone Tumor|Goal-Directed Fluid Therapy|Transfusion
Interventions: PROCEDURE: acute normovolemic hemodilution
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-06
Completion Date: 2026-05
Locations: The Second Affiliated Hospital of Zhejiang University anesthesiology department, Hangzhou, Zhejiang, 310000, China

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.

Primary Outcome Measures: Intraoperative allogeneic red blood cell transfusion volume, The volume of allogeneic red blood cell transfusions during the intraoperative period.

Between-group comparisons were performed using student t tests for normally distributed data, and Wilcoxon rank-sum tests otherwise., From the beginning to the end of the surgery
Secondary Outcome Measures: The rate of perioperative transfusion of allogeneic blood products, This includes blood products such as plasma and platelets, erythrocytes, From the start of surgery to discharge or the 7th day following the operation, which comes first|The blood loss during the perioperative period, The volume of blood loss, From the start of surgery to discharge or the 7th day following the operation, which comes first|The volume of fluid administration during the intraoperative period, This includes intraoperative crystalloid infusion volume and intraoperative colliod infusion volume, From the beginning to the end of the surgery|The coagulation function tests during the perioperative period, This includes thromboelastography result, From the start of surgery to discharge or the 7th day following the operation, which comes first|The intraoperative hemodynamic indexes, This includes stroke volume variation, From the beginning to the end of the surgery|Perioperative embolic events, This includes thrombosis and embolism, From the start of surgery to discharge or the 7th day following the operation, which comes first|Perioperative pulmonary infection, Diagnose according to radiologic examination, sign and symptom, From the start of surgery to discharge or the 7th day following the operation, which comes first|Perioperative wound infection, Diagnose according to sign, symptom, etc, From the start of surgery to discharge or the 7th day following the operation, which comes first|Length of stay in hospital, Through study completion, an average of 1 year