Acute Normovolemic Hemodilution in Bone Cancer Surgery
22. juni 2026 oppdatert 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Antatt)
420
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Zhejiang
-
Hangzhou, Zhejiang, Kina, 310000
- The Second Affiliated Hospital of Zhejiang University anesthesiology department
-
Hovedetterforsker:
- Min Yan, Doctor
-
Ta kontakt med:
- Min Yan, Doctor
- Telefonnummer: +86 15888210247
- E-post: zryanmin@zju.edu.cn
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Ingen inngripen: Control group
Except for not undergoing ANH, other care managements are the same as the experimental group
|
|
|
Eksperimentell: 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.
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Perioperative red blood cell transfusion rate
Tidsramme: hospital discharge, an average of 10 days
|
The number of patients receiving RBCs transfusion from the start of surgery to hospital discharge.
|
hospital discharge, an average of 10 days
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
The rate of perioperative transfusion of allogeneic blood products
Tidsramme: hospital discharge, an average of 10 days
|
This includes blood products such as plasma and platelets, erythrocytes
|
hospital discharge, an average of 10 days
|
|
Wound drainage volume
Tidsramme: hospital discharge, an average of 10 days
|
Accumulated amount of wound drainage after surgery
|
hospital discharge, an average of 10 days
|
|
Unplanned re-operation
Tidsramme: hospital discharge, an average of 10 days
|
Unplanned re-operation due to bleeding, infection or other reasons
|
hospital discharge, an average of 10 days
|
|
Perioperative hemoglobin concentration
Tidsramme: hospital discharge, an average of 10 days
|
hemoglobin concentration during hospitalization
|
hospital discharge, an average of 10 days
|
|
The coagulation function tests during the perioperative period
Tidsramme: hospital discharge, an average of 10 days
|
This includes thromboelastography result
|
hospital discharge, an average of 10 days
|
|
Complication
Tidsramme: hospital discharge, an average of 10 days
|
embolic events, pulmonary complications, infection, acute kidney injury, death.
Diagnose according to radiologic examination, sign and symptom
|
hospital discharge, an average of 10 days
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. juli 2026
Primær fullføring (Antatt)
1. juli 2026
Studiet fullført (Antatt)
1. mai 2028
Datoer for studieregistrering
Først innsendt
22. juni 2026
Først innsendt som oppfylte QC-kriteriene
22. juni 2026
Først lagt ut (Faktiske)
25. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
25. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
22. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 2026 0947
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .