Skip to content

Comparison of Exsanguination and Hemostasis Devices for Limb Surgery: A Prospective Multicenter Randomized Controlled Study

Comparison of Exsanguination and Hemostasis Devices for Limb Surgery: A Prospective Multicenter Randomized Controlled Study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300077998
Enrollment
Unknown
Registered
2023-11-27
Start date
2018-10-12
Completion date
Unknown
Last updated
2023-12-03

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

Conditions

Limb surgery requiring exsanguination and hemostasis

Interventions

Sponsors

the Second Affiliated Hospital of Zhejiang University, School of Medicine, Zhejiang, China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 78 Years

Inclusion criteria

Inclusion criteria: 1) Age between 18 and 78 years; 2) Underwent limb surgery requiring exsanguination and hemostasis; 3) Anticipated surgical duration within 60 minutes; 4) Upper arm circumference between 24-40 cm or mid-thigh circumference between 28-60 cm; 5) Were willing to participate, comply with study requirements, follow-up arrangements, and sign informed consent.

Exclusion criteria

Exclusion criteria: 1) Female patients pregnant or lactating during screening; 2) Severe skin damage on limbs; 3) Known inadequate peripheral blood flow, edema, or deep venous thrombosis; 4) Patients with limb infections or malignancies; 5) Patients who experienced severe discomfort, such as cardiovascular risks or respiratory difficulties, from prior tourniquet use; 6) Inability to stabilize systolic blood pressure below 180 mmHg preoperatively; 7) Participation in other drug or device clinical trials within the last month of screening; 8) Other circumstances deemed unsuitable by the investigator

Design outcomes

Primary

MeasureTime frame
Intraoperative blood loss;

Secondary

MeasureTime frame
Exsanguination and hemostasis effectiveness;Total blood loss;Hemoglobin content before and after surgery;

Countries

China

Contacts

Public ContactZhaoming Ye

Department of Orthopedics, the Second Affiliated Hospital of Zhejiang University, School of Medicine

yezhaominghz@163.com+86 135 0674 8317

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026