A prospective, multi-center, randomized controlled clinical study based on PK detection of orthopaedic perioperative coagulation factor precision replacement therapy in patients with haemophilia

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100044838

Enrollment

Unknown

Registered

2021-03-30

Start date

2021-04-01

Completion date

Unknown

Last updated

2021-10-26

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:coagulation factor precision replacement therapy based on PK detection

Control Group:maintain the upper limit of coagulation factor activity for replacement therapy recommended by hemophilia management guidelines

Eligibility

Sex/Gender

All

Age

16 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Hemophilia patients scheduled for surgery; 2. Aged 16-60 years; 3. Exposure days > 100; 4. With inhibitor negative; 5. Treated with recombinant coagulation factor VIII, XI.

Exclusion criteria

Exclusion criteria: 1. With inhibitor positive or inhibitor positive history; 2. With spinal or craniocerebral trauma; 3. With unclear thoracic or abdominal injury (suspected of visceral injury); 4. With previous history of thrombosis; 5. With serious complications, such as severe liver and kidney disease, cardiac insufficiency (NYHA III and above); 6. Disagree to sign the informed consent.

Design outcomes

Primary

Measure	Time frame
Perioperative blood loss;Perioperative coagulation factor dosage;Coagulation factor activity level;	—

Secondary

Measure	Time frame
The time and drainage volume of drainage tube;Postoperative complications;Hospital costs;	—

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