Acute Normovolemic Hemodilution in Bone Cancer Surgery
22. juni 2026 opdateret af: Second Affiliated Hospital, School of Medicine, Zhejiang University
The Effect of Acute Normovolemic Hemodilution on Requirement of Allogeneic Red Blood Cell in Patients Undergoing Bone Cancer Surgery
Malignant bone tumors often lead to skeletal complications, known as skeletal related events (SRE).
These complications mainly include pathological fractures, severe pain, and spinal cord compression.
Typically, SRE reduces overall survival rates and is associated with loss of mobility and social functioning, decreased quality of life, and significantly increased healthcare costs.
Surgical resection is an important means of treating malignant bone tumors.
The main goal of surgical treatment is to maintain the patient's function and mobility by relieving pain, preventing impending fractures and/or nerve compression, or stabilizing pathological fractures.
Surgery for malignant bone tumors often requires extensive exploration, osteotomy, and prosthetic reconstruction.
The surgery involves significant trauma and excessive bleeding from the wound.
Therefore, there is a significant risk of perioperative blood loss and transfusion during surgery for malignant bone tumors.
However, blood transfusion also brings transfusion related risks to patients, increases the incidence of postoperative complications, and increases the healthcare burden on patients and society.
Acute normovolemic hemodilution (ANH) may help reduce allogeneic red blood cell transfusion.
However, There is a lack of high-quality evidence to support the use of ANH in bone cancer surgery.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Malignant bone tumors often lead to skeletal complications, known as skeletal related events (SRE).
These complications mainly include pathological fractures, severe pain, and spinal cord compression.
Typically, SRE reduces overall survival rates and is associated with loss of mobility and social functioning, decreased quality of life, and significantly increased healthcare costs.
Surgical resection is an important means of treating malignant bone tumors.
The main goal of surgical treatment is to maintain the patient's function and mobility by relieving pain, preventing impending fractures and/or nerve compression, or stabilizing pathological fractures.
Surgery for bone cancer often requires extensive exploration, osteotomy, and prosthetic reconstruction.
The surgery involves significant trauma and excessive bleeding from the wound.
Therefore, there is a significant risk of perioperative blood loss and transfusion during surgery for malignant bone tumors.
However, blood transfusion also brings transfusion related risks to patients, increases the incidence of postoperative complications, and increases the healthcare burden on patients and society.
Therefore, it is particularly important to develop a perioperative blood management (PBM) plan for these patients.
Acute normovolemic hemodilution (ANH) may help reduce allogeneic red blood cell transfusion.
However, There is a lack of high-quality evidence to support the use of ANH in bone cancer surgery.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
420
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Zhejiang
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Hangzhou, Zhejiang, Kina, 310000
- The Second Affiliated Hospital of Zhejiang University anesthesiology department
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Ledende efterforsker:
- Min Yan, Doctor
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Kontakt:
- Min Yan, Doctor
- Telefonnummer: +86 15888210247
- E-mail: zryanmin@zju.edu.cn
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- age 18 more than years;
- undergoing elective bone cancer resection surgery;
- preoperative hemoglobin ≥12 g/dL;
Exclusion Criteria:
- using a tourniquet;
- BMI<18.5 Kg/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 colloid solution;
- pregnancy;
- declined participation in the study or declined blood transfusion
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Ingen indgriben: Control group
Except for not undergoing ANH, other care managements are the same as the experimental group
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Eksperimentel: ANH group
Patients in the ANH group had whole blood withdrawn after induction of anesthesia.
Meanwhile, patients receive colloid solution according to the volume of blood withdrawn.
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The whole blood is withdrawn after induction of anesthesia.
Blood is withdrawn from a large-bore catheter and stored in blood bags.
Meanwhile, patients receive colloid solution according to the volume of blood withdrawn.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Perioperative red blood cell transfusion rate
Tidsramme: hospital discharge, an average of 10 days
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The number of patients receiving RBCs transfusion from the start of surgery to hospital discharge.
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hospital discharge, an average of 10 days
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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The rate of perioperative transfusion of allogeneic blood products
Tidsramme: hospital discharge, an average of 10 days
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This includes blood products such as plasma and platelets, erythrocytes
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hospital discharge, an average of 10 days
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Wound drainage volume
Tidsramme: hospital discharge, an average of 10 days
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Accumulated amount of wound drainage after surgery
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hospital discharge, an average of 10 days
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Unplanned re-operation
Tidsramme: hospital discharge, an average of 10 days
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Unplanned re-operation due to bleeding, infection or other reasons
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hospital discharge, an average of 10 days
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Perioperative hemoglobin concentration
Tidsramme: hospital discharge, an average of 10 days
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hemoglobin concentration during hospitalization
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hospital discharge, an average of 10 days
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The coagulation function tests during the perioperative period
Tidsramme: hospital discharge, an average of 10 days
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This includes thromboelastography result
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hospital discharge, an average of 10 days
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Complication
Tidsramme: hospital discharge, an average of 10 days
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embolic events, pulmonary complications, infection, acute kidney injury, death.
Diagnose according to radiologic examination, sign and symptom
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hospital discharge, an average of 10 days
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. juli 2026
Primær færdiggørelse (Anslået)
1. juli 2026
Studieafslutning (Anslået)
1. maj 2028
Datoer for studieregistrering
Først indsendt
22. juni 2026
Først indsendt, der opfyldte QC-kriterier
22. juni 2026
Først opslået (Faktiske)
25. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
25. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 2026 0947
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Kliniske forsøg med Acute Normovolemic Hemodilution
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