Acute Normovolemic Hemodilution in Bone Cancer Surgery
22 juni 2026 uppdaterad av: 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
420
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
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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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Huvudutredare:
- Min Yan, Doctor
-
Kontakt:
- Min Yan, Doctor
- Telefonnummer: +86 15888210247
- E-post: zryanmin@zju.edu.cn
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Inget ingripande: Control group
Except for not undergoing ANH, other care managements are the same as the experimental group
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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Perioperative red blood cell transfusion rate
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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The rate of perioperative transfusion of allogeneic blood products
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 juli 2026
Primärt slutförande (Beräknad)
1 juli 2026
Avslutad studie (Beräknad)
1 maj 2028
Studieregistreringsdatum
Först inskickad
22 juni 2026
Först inskickad som uppfyllde QC-kriterierna
22 juni 2026
Första postat (Faktisk)
25 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
25 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
22 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 2026 0947
Läkemedels- och apparatinformation, studiedokument
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