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Effects of repeated intravenous administration of tranexamic acid on immune function during total hip replacement: a randomized controlled trial

Evaluation of safety and efficacy of joint replacement

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900027950
Enrollment
Unknown
Registered
2019-12-06
Start date
2019-12-01
Completion date
Unknown
Last updated
2019-12-10

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

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. patients diagnosed as osteoarthritis of hip joint and necrosis of femoral head with unilateral primary artificial THA indication; 2. Preoperative Hb and coagulation function were normal; No abnormality was found in the color doppler ultrasound of the veins of both lower extremities. 3. Above 18 years.

Exclusion criteria

Exclusion criteria: 1. DDH secondary osteoarthritis (Crowe type 3 or 4); 2. History of thromboembolism (i.e., DVT, or pulmonary embolism (PE)), thromboembolism, recent arterial thromboembolism events (e.g., myocardial infarction or stroke), hypercoagulability, hemophilia; 3. Serious cardiovascular and respiratory diseases; Renal and liver failure, history of kidney transplantation; 4. refuse to participate in or refuse to accept blood products; 5. The patient had a history of bilateral hip arthroplasty; 6. tranexamic acid allergy;Patients prone to thrombosis (after atrial fibrillation, pacemaker and stent implantation).

Design outcomes

Primary

MeasureTime frame
Dissolution index: d-dimer, FDP;Immune indicators: plasma levels of immunoglobulin (IgG, IgA, IgM, IgE) and complement (C3, C4), lymphocyte subsets (CD3 lymphocytes, CD4 lymphocytes (Th1/Th2), CD8 lymphocytes and CD4 / CD8 ratio);

Secondary

MeasureTime frame
Inflammatory markers: IL - 8, the WBC, c-reactive protein (C - reactive protein, CRP), erythrocyte sedimentation rate, erythrocyte sedimentation rate, the ESR), interleukin - 6 (intedeukin - 6, IL - 6) expression of TNF alpha, beta, IL - 1 IL - 4;

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