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Design of a randomized, controlled trial of continuous versus bolus infusions under preoperative pharmacokinetic-guided by Recombinant Human Coagulation Factor VIII (Omfiloctocog alfa, SCT800) in haemophilia A

Design of a randomized, controlled trial of continuous versus bolus infusions under preoperative pharmacokinetic-guided by Recombinant Human Coagulation Factor VIII (Omfiloctocog alfa, SCT800) in haemophilia A

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068747
Enrollment
Unknown
Registered
2023-02-28
Start date
2023-03-01
Completion date
Unknown
Last updated
2023-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Haemophilia orthopaedic disorders

Interventions

Experimental Group:perioperative continuous infusion
Control Group:perioperative bolus infusions

Sponsors

Nanfang Hospital,Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to 66 Years

Inclusion criteria

Inclusion criteria: ? Treated patients who plan to undergo elective surgery and are diagnosed with hemophilia A; ?Age 12-66 years old; ? Negative inhibitors (less than 0.6 BU/mL) and no positive history of inhibitors; ? Exposure days > 100 days; ? HIV negative, if HIV positive, CD4 lymphocytes should be >200/µl, and the viral load should be <200 grains/µl or <400,000 copies/ml; ?The subjects or their representatives have the ability to sign the informed consent.

Exclusion criteria

Exclusion criteria: ?Patients who are known or suspected to be allergic to Anjiain, including those allergic to hamster protein or related products; ? Positive inhibitors or a history of positive inhibitors; ?Patients with other congenital or acquired coagulation disorders; ? Those with a history of deep vein thrombosis, pulmonary embolism, acute myocardial ischemia and disseminated intravascular coagulation; ?Participated in other clinical trials 30 days before enrollment; ? Severe complications (such as severe liver and kidney disease, cardiac insufficiency, NYHA grade III and above) or conditions that the investigator believes may cause potential harm to the patient and interfere with the implementation of the study and the results of the study; ?Do not agree to sign the informed consent form; ? Behavioral or cognitive impairment and alcohol, drug addicts.

Design outcomes

Primary

MeasureTime frame
Evaluation of surgical hemostasis;

Secondary

MeasureTime frame
Perioperative changes in hemoglobin;Perioperative changes in hematocrit;perioperative blood transfusion;Perioperative blood loss;Perioperative coagulation factor dosage;Coagulation factor activity level;Hemophilia Joint Health Scale;EQ-5D;

Countries

China

Contacts

Public ContactChen Bin

Nanfang Hospital,Southern Medical University

chenbin1@smu.edu.cn+86 13076872794

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026