[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-normovolemic-hemodilution\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-normovolemic-hemodilution":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,40,62,85,102],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100643930","acute-normovolemic-hemodilution-in-bone-cancer-surgery-100643930",false,"NCT07669155","Acute Normovolemic Hemodilution in Bone Cancer Surgery","The Effect of Acute Normovolemic Hemodilution on Requirement of Allogeneic Red Blood Cell in Patients Undergoing Bone Cancer Surgery","Inclusion Criteria:\n\n1. age 18 more than years;\n2. undergoing elective bone cancer resection surgery;\n3. preoperative hemoglobin ≥12 g\u002FdL;\n\nExclusion Criteria:\n\n1. using a tourniquet;\n2. BMI\\\u003C18.5 Kg\u002Fm\\^2;\n3. international normalized ratio (INR) \\>1.5 or platelet count \\\u003C100 × 10\\^9\u002FL;\n4. cardiopulmonary insufficiency;\n5. hepatic and renal dysfunction;\n6. active infectious disease;\n7. allergy to colloid solution;\n8. pregnancy;\n9. declined participation in the study or declined blood transfusion","ALL","18 Years",{"count":19,"type":20},420,"ESTIMATED","INTERVENTIONAL",[23],"NA","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\u002For 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.",[26],"Acute Normovolemic Hemodilution","NOT_YET_RECRUITING","2026-06-22",{"date":30,"type":31},"2026-06-25","ACTUAL",{"date":33,"type":20},"2026-07",{"date":35,"type":20},"2028-05",{"name":37,"class":38},"Second Affiliated Hospital, School of Medicine, Zhejiang University","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":57,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":61,"locationsCount":39},"100551365","the-effect-of-acute-normovolemic-hemodilution-in-bone-tumor-surgery-100551365","NCT06459141","The Effect of Acute Normovolemic Hemodilution in Bone Tumor Surgery","The Effect of Acute Normovolemic Hemodilution on Intraoperative Allogeneic Transfusion in Bone Tumor Surgery: a Prospective, Randomized Controlled Trial","Inclusion Criteria:\n\n1. age 18 to 75 years;\n2. undergoing elective bone tumor resection surgery;\n3. preoperative hemoglobin ≥11 g\u002FdL;\n\nExclusion Criteria:\n\n1. using a tourniquet;\n2. palliative operation or minimally invasive surgery;\n3. BMI\\\u003C18.5 or \\>30Kg\u002Fm\\^2;\n4. international normalized ratio (INR) \\>1.5 or platelet count \\\u003C100 × 10\\^9\u002FL;\n5. cardiopulmonary insufficiency;\n6. hepatic and renal dysfunction;\n7. active infectious disease;\n8. allergy to succinyl gelatin;\n9. pregnancy;\n10. declined participation in the study or declined blood transfusion","75 Years",{"count":49,"type":20},150,[23],"The prevention of intraoperative allogenetic blood transfusion has the potential to reduce complications, hospital stays, and long-term prognosis in patients undergoing bone cancer surgery. Data from previous studies suggest that the clinical efficacy of acute normovolemic hemodilution (ANH) has always been controversial. The HEAL trial will assess whether ANH will reduce the volume of intraoperative allogeneic red blood cell transfusion in patients undergoing bone cancer surgery.",[26,53,54,55],"Bone Tumor","Goal-Directed Fluid Therapy","Transfusion","RECRUITING",{"date":30,"type":31},{"date":59,"type":31},"2024-06-07",{"date":35,"type":20},{"name":37,"class":38},{"id":63,"slug":64,"hasResults":11,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":4,"eligibilityCriteria":68,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":69,"enrollmentInfo":70,"targetDuration":4,"studyType":21,"phases":72,"briefSummary":73,"conditions":74,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":39},"100591232","clinical-study-on-the-effectiveness-and-safety-of-succinylated-gelatin-electrolyte-sodium-acetate-injection-100591232","NCT06977750","Clinical Study on the Effectiveness and Safety of Succinylated Gelatin Electrolyte Sodium Acetate Injection","A Multicenter, Randomized, Double-blind, Positive Controlled Clinical Study on the Efficacy and Safety of Succinylated Gelatin Electrolyte Sodium Acetate Injection for Acute Isovolumetric Hemodilution (ANH) in Elective Surgery","Inclusion Criteria:\n\n1. Age range is 18 to 65 years old (including boundary values), with no gender restrictions.\n2. Weight not less than 50 kg, weight not more than 100 kg, body mass index \\[BMI=weight (kg)\u002Fheight 2 (m2)\\] within the range of 19.0\\~30.0 kg\u002Fm2 (including critical values).\n3. Planned elective surgery with an estimated duration of less than 6 hours.\n4. The expected ANH blood collection volume is 10% to 15% of the total blood volume.\n5. Prior to enrollment, the Hb level of the subjects was ≥ 110 g\u002FL.\n6. The American Society of Anesthesiologists (ASA) has a rating of I-III.\n7. Voluntarily participate in this experiment and sign a written informed consent form.\n\nExclusion Criteria:\n\n1. Individuals with a history of severe cerebrovascular disease or severe mental illness, who have been deemed unsuitable by the researchers to participate in this trial.\n2. Previous indications include heart valve disease, aortic stenosis, and severe peripheral vascular disease (such as a history of arteriosclerosis), and the researchers have determined that they are not suitable to participate in this trial.\n3. Suffering from serious heart diseases, including but not limited to unstable angina, cerebrovascular accidents or transient ischemic stroke (within 6 months before screening), myocardial infarction (within 6 months before screening), New York Heart Association (NYHA) classification ≥ III, congestive heart failure, severe arrhythmia with poor drug control, requiring mechanical maintenance (such as pacemakers), placing heart stents or abnormal results of echocardiography and\u002For 12 lead electrocardiogram during screening, has clinical significance.\n4. Patients with hypertension have poor blood pressure control (SBP ≥ 160mmHg and\u002For DBP ≥ 100mmHg), and cannot discontinue long-term antihypertensive drugs such as angiotensin-converting enzyme inhibitors\u002Fangiotensin II receptor antagonists and potassium sparing diuretics 10 hours before surgery, and the researchers have determined that they are not suitable to participate in this trial.\n5. Individuals with a history of liver cirrhosis or liver dysfunction during screening and deemed unsuitable for surgery by researchers: AST or ALT\\>2 times the upper limit of normal values; Albumin level\\\u003C35 g\u002FL; Blood bilirubin is greater than 1.5 times the upper limit of normal value.\n6. Patients with abnormal renal function assessment during screening and deemed unsuitable for surgery by researchers: Cr or BUN\\>1.5 times the upper limit of normal values.\n7. There are any of the following respiratory management risks during screening: 1) history of asthma (such as allergic asthma), wheezing; 2) Individuals with sleep apnea syndrome;\n8. Hematological disorders such as sickle cell anemia, thalassemia, and pheochromocytoma.\n9. There is a significant risk of bleeding or coagulation disorders, and the researchers assess that surgery is not suitable, including but not limited to: a) past\u002Fcurrent thrombotic or thromboembolic events, or an increased risk of thrombotic or thromboembolic events; b) Require the use of antiplatelet or anticoagulant drugs (such as warfarin and clopidogrel) other than aspirin (up to 100 mg\u002Fd); c) Having a history of gastrointestinal, intracerebral hemorrhage, or other events considered severe bleeding, such as bleeding caused by the use of nonsteroidal anti-inflammatory drugs; d) PT prolongation\\>upper limit of normal value of 3 seconds or APTT prolongation\\>upper limit of normal value of 10 seconds, and the researcher evaluates it as unsuitable for surgery; e) PLT\\\u003C80 × 109\u002FL.\n10. Diabetes patients with poor control, such as glycosylated hemoglobin ≥ 7%, and the investigator judged that they were not suitable to participate in the trial.\n11. History of malignant tumors (excluding non metastatic basal cell carcinoma or squamous cell carcinoma, papillary thyroid carcinoma, and cervical cancer in situ that have been cured for ≥ 5 years and do not require follow-up).\n12. Excessive blood volume (such as polycythemia vera) and fluid overload (such as systemic edema).\n13. There is an active infection with poor control, which the researchers believe makes the subjects unsuitable to participate in this clinical study.\n14. Preoperative complications include pulmonary edema, dehydration, burns, intestinal obstruction, critical illnesses such as sepsis, multiple organ failure, respiratory distress syndrome, organ transplantation, shock, etc.\n15. When screening, there is a water electrolyte imbalance (such as hypercalcemia, hyperkalemia, etc.) and the researcher believes that the abnormality has clinical significance and is not suitable to participate in this clinical study.\n16. Having undergone major surgeries or surgical incisions that have not fully healed within the first 6 months of screening: Major surgeries include but are not limited to any surgeries with significant bleeding risks, prolonged general anesthesia periods, or significant traumatic injuries.\n17. Received anemia related treatment, colloidal solution, and\u002For blood products 14 days before surgery.\n18. Those who have received the vaccine within one month before surgery.\n19. Individuals who are known to be allergic to any component of the investigational drug; Known to be allergic to meat, especially red meat (mammalian meat) or internal organs; Known individuals who are allergic to lactose - α -1,3-galactose; And subjects with a history of severe allergic reactions (such as urticaria, angioedema, etc.).\n20. Has a history of drug abuse in the past.\n21. Patients who cannot discontinue corticosteroids, nonsteroidal anti-inflammatory drugs, cyclosporine, tacrolimus, or succinylcholinergic drugs within 7 days before surgery (or within 5 half lives of the drug, whichever is shorter).\n22. Pregnant or lactating women, as well as male subjects (or their partners) or female subjects who have a pregnancy plan or are unwilling to use at least one medically recognized effective contraceptive measure (such as intrauterine device or condom) during the study period until 1 month after the last use of medication.\n23. Those who have participated in any other non observational clinical trials and used the study drug or device within one month prior to the trial;\n24. Participants may not be able to complete this study due to other reasons or may have other reasons deemed inappropriate by the researchers to participate in the trial.","65 Years",{"count":71,"type":20},104,[23],"The succinylated gelatin electrolyte sodium acetate injection (specification: 500 mL: 20 g) developed and produced by Nanjing Chia-tai Tianqing Pharmaceutical. is used as the experimental drug, and the succinylated gelatin electrolyte sodium acetate injection (trade name: Jialeban) produced and licensed by Braun Medical (Suzhou) Co., Ltd ®； Specification: 500 mL: 20 g) is used as a control drug to evaluate the clinical equivalence of two formulations in patients planning elective surgery by comparing the changes in stroke volume (SV) between 5 minutes after completion of ANH and immediately before the start of ANH.",[26],"2025-05-11",{"date":77,"type":31},"2025-05-18",{"date":79,"type":31},"2025-04-27",{"date":81,"type":20},"2025-12-31",{"name":83,"class":84},"Nanjing Chia-tai Tianqing Pharmaceutical","INDUSTRY",{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":69,"enrollmentInfo":92,"targetDuration":4,"studyType":21,"phases":93,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":96,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":4},"100591233","clinical-study-on-the-effectiveness-and-safety-of-succinylated-gelatin-injection-100591233","NCT06977763","Clinical Study on the Effectiveness and Safety of Succinylated Gelatin Injection","A Multicenter, Randomized, Double-blind, Positive Controlled Clinical Study on the Efficacy and Safety of Succinylated Gelatin Injection for Acute Isovolumetric Hemodilution (ANH) in Elective Surgery","Inclusion Criteria:\n\n1. Age range is 18 to 65 years old (including boundary values), with no gender restrictions.\n2. Weight not less than 50 kg, weight not more than 100 kg, body mass index \\[BMI=weight (kg)\u002Fheight 2 (m2)\\] within the range of 19.0\\~30.0 kg\u002Fm2 (including critical values).\n3. Planned elective surgery with an estimated duration of less than 6 hours.\n4. The expected ANH blood collection volume is 10% to 15% of the total blood volume.\n5. Prior to enrollment, the Hb level of the subjects was ≥ 110 g\u002FL.\n6. The American Society of Anesthesiologists (ASA) has a rating of I-III.\n7. Voluntarily participate in this experiment and sign a written informed consent form.\n\nExclusion Criteria:\n\n1. Individuals with a history of severe cerebrovascular disease or severe mental illness, who have been deemed unsuitable by the researchers to participate in this trial.\n2. Individuals who have a history of heart valve disease, aortic stenosis, and severe peripheral vascular disease (such as arteriosclerosis) and are deemed unsuitable to participate in this trial by the researchers.\n3. Suffering from severe heart disease, including but not limited to a history of unstable angina, cerebrovascular accident or transient ischemic stroke (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), congestive heart failure, severe arrhythmia with poor drug control, requiring mechanical maintenance (such as pacemakers), placement of cardiac stents or New York Heart Association (NYHA) classification ≥ III at the time of screening, abnormal results on echocardiography and\u002For 12 lead electrocardiogram have clinical significance.\n4. Patients who have previously suffered from pheochromocytoma or had poor blood pressure control during screening (SBP ≥ 160mmHg and\u002For DBP ≥ 100mmHg), and the researchers have determined that they are not suitable to participate in this trial.\n5. Individuals with a history of liver cirrhosis or abnormal liver function during screening and deemed unsuitable for participation in this trial by the researchers: AST or ALT\\>2 times the upper limit of normal values; Albumin level\\\u003C35 g\u002FL; Blood bilirubin is greater than 1.5 times the upper limit of normal value.\n6. Having any of the following respiratory management risks in the past: 1) history of asthma (such as allergic asthma); 2) People with sleep apnea syndrome.\n7. Previously suffered from hematological disorders such as sickle cell anemia, thalassemia, etc.\n8. Patients with previous or current malignant tumors (excluding non metastatic basal cell carcinoma or squamous cell carcinoma, papillary thyroid carcinoma, and cervical cancer in situ that have been cured for ≥ 5 years and do not require follow-up).\n9. There is a significant risk of bleeding or coagulation disorders, and the researcher evaluates those who are not suitable to participate in this trial, including but not limited to: a) past\u002Fcurrent thrombosis or thromboembolic events; b) Patients who stop using antiplatelet or anticoagulant drugs (such as warfarin and clopidogrel) before surgery and have not reached a half-life of 7 days or more (whichever is shorter), except for aspirin (up to 100 mg\u002Fd) and low molecular weight heparin (routine prophylactic use before surgery); c) Having a history of gastrointestinal, intracerebral hemorrhage, or other events considered severe bleeding, such as bleeding caused by the use of nonsteroidal anti-inflammatory drugs; d) When screening, PT extension\\>upper limit of normal value for 3 seconds or APTT extension\\>upper limit of normal value for 10 seconds, and the researcher evaluates it as unsuitable for surgery; e) PLT\\\u003C80 × 109\u002FL during screening.\n10. Individuals with abnormal renal function assessment during screening and deemed unsuitable for participation in this trial by the researchers: Cr or BUN\\>1.5 times the upper limit of normal values.\n11. Individuals with excessive fluid load during screening (such as systemic edema) and deemed unsuitable for participation in this trial by the researchers.\n12. There were active infections with poor control during screening, and the researchers deemed it unsuitable to participate in this trial.\n13. During screening, pulmonary edema, dehydration, burns, intestinal obstruction, critical illnesses such as sepsis, multiple organ failure, respiratory distress syndrome, organ transplantation, shock, etc. are combined.\n14. Individuals with water electrolyte imbalance (such as hypercalcemia, hyperkalemia, etc.) during screening and deemed clinically significant by the researchers are not suitable to participate in this trial.\n15. Having undergone major surgeries or surgical incisions that have not fully healed within the first 6 months of screening: Major surgeries include but are not limited to any surgeries with significant bleeding risks, prolonged general anesthesia periods, or significant traumatic injuries.\n16. Received anemia related treatment, colloidal solution, and\u002For blood products 14 days before surgery.\n17. If corticosteroids or nonsteroidal anti-inflammatory drugs cannot be discontinued within 7 days before surgery (or within 5 half lives of the drug, whichever is shorter), or if drugs that affect the subject's blood volume cannot be discontinued within 1 day before surgery (such as mannitol, etc.).\n18. Individuals who are known to be allergic to any component of the investigational drug; Known to be allergic to meat, especially red meat (mammalian meat) or internal organs; Known individuals who are allergic to lactose - α -1,3-galactose; And subjects with a history of severe allergic reactions (such as urticaria, angioedema, etc.).\n19. Pregnant or lactating women, as well as male subjects (or their partners) or female subjects who have a pregnancy plan during the study period until 1 month after the last use of medication, or who are unwilling to use at least one medically recognized effective contraceptive measure (such as intrauterine devices or condoms) during the study period until 1 month after the last use of medication.\n20. Individuals who have participated in any other non observational clinical trials and used the study drug or device within one month prior to the trial;\n21. Other situations that the researcher deems unsuitable to participate in this experiment.",{"count":71,"type":20},[23],"The succinylated gelatin injection (specification: 500 mL: 20 g) developed and produced by Nanjing Chia-tai Tianqing Pharmaceutical.. is used as the experimental drug, and the succinylated gelatin injection (trade name: Gelofusine) produced by B. Braun Melsungen AG is licensed ®； Specification: 500 mL: 20 g) is used as a control drug to evaluate the clinical equivalence of two formulations in patients planning elective surgery by comparing the changes in stroke volume (SV) between 5 minutes after completion of ANH and immediately before the start of ANH.",[26],{"date":77,"type":31},{"date":98,"type":20},"2025-07-01",{"date":100,"type":20},"2025-12-01",{"name":83,"class":84},{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":106,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":107,"targetDuration":4,"studyType":21,"phases":109,"briefSummary":110,"conditions":111,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":116,"leadSponsor":118,"locationsCount":39},"100583835","a-substudy-of-the-effect-of-acute-normovolemic-hemodilution-in-bone-tumor-surgery-100583835","NCT06881498","A Substudy of the Effect of Acute Normovolemic Hemodilution in Bone Tumor Surgery",{"count":108,"type":20},32,[23],"The prevention of perioperative anemia 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 improve postoperative hemoglobin levels when applying goal-directed fluid therapy in patients undergoing bone tumor surgery.",[53,26,54],"2025-04-13",{"date":114,"type":31},"2025-04-15",{"date":59,"type":31},{"date":117,"type":20},"2026-05",{"name":37,"class":38}]