The Effect of Acute Normovolemic Hemodilution in Bone Tumor Surgery

NCT06459141 | Recruiting DMC

• 1 other identifier: 2024-0156
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Normovolemic Hemodilution; Bone Tumor; Goal-Directed Fluid Therapy; Transfusion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• The rate of perioperative transfusion of allogeneic blood products

  From the start of surgery to discharge or the 7th day following the operation, which comes first

• The blood loss during the perioperative period

  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

  From the beginning to the end of the surgery

• The coagulation function tests during the perioperative period

  From the start of surgery to discharge or the 7th day following the operation, which comes first

• The intraoperative hemodynamic indexes

  From the beginning to the end of the surgery

Study Arms (2)

acute normovolemic hemodilution group (ANH group)

EXPERIMENTAL

The ANH process was initiated after tracheal intubation. After completion of ANH, goal-directed fluid therapy will begin until the end of the surgery.

Procedure: acute normovolemic hemodilution

Standard Group (STD group)

NO INTERVENTION

After tracheal intubation, goal-directed fluid therapy will be implemented until the end of the surgery.

Interventions

acute normovolemic hemodilution PROCEDURE

The ANH was conducted with more than 8 ml/kg of whole blood drawn from an internal jugular introducer by gravity and collected into standard sterile blood storage bags containing citrate phosphate-dextrose anticoagulant. The allowable blood loss was capped according to the preoperative hemoglobin, estimated blood volume, and the target hemoglobin (10 g/dL). The collected blood was simultaneously replaced by an equal volume of succinyl gelatin solution via at least one large bore peripheralvenous catheter to maintain hemodynamic stability.

acute normovolemic hemodilution group (ANH group)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18 to 75 years;
• undergoing elective bone tumor resection surgery;
• preoperative hemoglobin ≥11 g/dL;

You may not qualify if:

• using a tourniquet;
• palliative operation or minimally invasive surgery;
• BMI\<18.5 or \>30Kg/m\^2;
• international normalized ratio (INR) \>1.5 or platelet count \<100 × 10\^9/L;
• cardiopulmonary insufficiency;
• hepatic and renal dysfunction;
• active infectious disease;
• allergy to succinyl gelatin;
• pregnancy;
• declined participation in the study or declined blood transfusion

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University anesthesiology department

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Bone Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2024
• First Posted: June 14, 2024
• Study Start: June 7, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: March 14, 2025

Record last verified: 2024-05

Locations

CN (1)