Hemophilia A
Conditions
Interventions
Weight-Based Dosing Group:Weight-based factor VIII dosing
Perioperative PK Model Group:Perioperative PK model-guided factor VIII dosing
Sponsors
Southern Medical University Southern Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Patients diagnosed with Hemophilia A who are scheduled to undergo elective orthopedic surgery; 2.Aged between 18 and 65 years; 3.Negative for FVIII inhibitors (defined as <0.6 BU/mL) with no prior history of inhibitor positivity; 4.More than 75 exposure days to factor VIII products; 5.Normal levels of infection-related laboratory parameters, including erythrocyte sedimentation rate (ESR), total white blood cell count, neutrophil count, and C-reactive protein (CRP); 6.The subject or their legal representative is capable of providing written informed consent;
Exclusion criteria
Exclusion criteria: 1.Patients with other congenital or acquired coagulation disorders; 2.History of deep vein thrombosis, pulmonary embolism, acute myocardial ischemia, or disseminated intravascular coagulation (DIC); 3.Participation in another clinical trial within 30 days prior to enrollment; 4.Presence of severe comorbidities (e.g., advanced hepatic or renal disease, New York Heart Association [NYHA] class III or higher heart failure) or other conditions that, in the investigator’s judgment, may pose potential risks or interfere with the conduct or outcomes of the study; 5.Refusal or inability to provide written informed consent; 6.Patients with behavioral or cognitive impairments, or those with a history of alcohol or substance abuse;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average perioperative factor VIII consumption (IU/kg); | — |
Secondary
| Measure | Time frame |
|---|---|
| Fit of perioperative factor VIII activity levels (including coefficient of variation and out-of-target rate of FVIII:C levels);Postoperative drainage volume;Incidence of perioperative postoperative complications (e.g., subcutaneous hematoma, major bleeding, wound infection, delayed wound healing, thrombosis, pulmonary infection, reoperation, inhibitor dev;Intraoperative hemostatic efficacy score;Hospitalization cost;Length of hospital stay; | — |
Countries
China
Contacts
Public ContactBin Chen
Southern Medical University Southern Hospital
Outcome results
None listed