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Evaluation of hemostatic efficacy of tranexamic acid combined with carbazochrome sodium sulfonate in total hip arthroplasty: a randomized controlled trial

Blood loss management and fast rehabilitation for patients undergoing total hip arthroplaty

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800020094
Enrollment
Unknown
Registered
2018-12-14
Start date
2018-12-18
Completion date
Unknown
Last updated
2019-01-28

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

Conditions

osteoarthritis or Osteonecrosis of femoral head

Interventions

Group A:Tranexamic acid (intravenous) + carbazochrome sodium sulfonate (periarticular capsule infiltration + intravenous injection)
Group B:Tranexamic acid (intravenous) + carbazochrome sodium sulfonate (periarticular capsule infiltration )
Group C:Tranexamic acid (intravenous) + carbazochrome sodium sulfonate ( intravenous injection)
Group D:Tranexamic acid (intravenous)

Sponsors

Department of Orthopedics, West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
25 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. patients with osteoarthritis or osteonecrosis of the femoral head (Ficat III and IV) and have to undergo THA; 2. BMI: 20-35 kg/m2; 3. American Society of Anesthesiologists degree before operation: I~III grade.

Exclusion criteria

Exclusion criteria: (1) allergic to tranexamic acid, carlosulfonate, anesthetic drugs; (2) DDH secondary osteoarthritis (Crowe type 3 or 4), femoral head necrosis; (3) thromboembolic disease history (that is, deep vein thrombosis (DVT), or pulmonary embolism (PE)), coagulation disease, recent arterial thromboembolic events (such as myocardial infarction or stroke), hypercoagulation state, hemophilia; (4) serious cardiovascular and respiratory diseases;Kidney and liver failure, history of kidney transplantation; (5) refuse to participate in or accept blood products; (6) the patient has a history of bilateral hip arthroplasty and used anticoagulants or birth control pills 5 days before surgery.

Design outcomes

Primary

MeasureTime frame
total blood loss; reduction in haemoglobin concentration;inflammatory cytokines;—

Secondary

MeasureTime frame
haemoglobin (HB);haematocrit;Thromboelastographic; intra-operative blood loss;transfusion rates; Length of postoperative hospital stay;Coagulation and fibrinolysis parameters;—

Countries

China

Contacts

Public ContactKang Pengde

Department of Orthopedics, West China Hospital, Sichuan University

kangpd@163.com+86 18980601953

Outcome results

None listed

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