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Efficacy and safety of orally and intravenously administration of tranexamic acid in patients with elderly femoral neck fracture

Efficacy and safety of orally and intravenously administration of tranexamic acid in patients with elderly femoral neck fracture

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082898
Enrollment
Unknown
Registered
2024-04-10
Start date
2020-08-02
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

femoral neck fracture

Interventions

Oral group. :1. Oral group: 2 g TXA was orally administered 2 hours before surgery.
Intravenous group:1g TXA was Intravenously administered before incision.
Control group:receive no special intervention related to TXA, usual hemostatic methods including electrocoagulation, anesthetic-controlled hypotension during operation and compression dressing of woun

Sponsors

Department of Orthopaedics, Zhongda Hospital, School of Medicine, Southeast University, No. 87 Ding Jia Qiao, Nanjing 210009, Jiangsu Province, China.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1.patients aged =65 years and =85 years old at the time of admission; 2. diagnosed as displaced femoral neck fracture (Garden type III or IV), and the time from the fracture to operation was less than 2 weeks; 3. agree to receive hip arthroplasty surgery; 4. agrees to participate the trial and signed the Informed consent

Exclusion criteria

Exclusion criteria: 1. Recieving anticoagulants (vitamin K antagonists, thrombin inhibitors, antiplatelet drugs, factor II and X inhibitors) or thrombin at the time of admission, ; 2.Combined with other fractures that require surgery; 3. Allergy to TXA; 4. Had history of DVT or PE; 5. Combined with liver dysfunction: alanine aminotransferase (ALT)>40 U/L, aspartate aminotransferase (AST)>40 U/L, or PTA171umol/L; 6. Combined with renal insufficiency: serum urea (BUN)>7.1 µ Mol/L; Blood creatinine (SCr)>110umol/L or glomerular filtration rate below 90ml/min; 7. Combined with active coronary artery disease (past 12 months); 8. Medical history of CVA in the past 12 months; 9. Undergoing drug eluting stent implantation surgery; 10.Combined with leukemia or active cancer; 11. Patients in a hypercoagulable state with serum prothrombin time (PT)<9s and partially activated prothrombin time (APTT)<20s upon admission; 12. Concomitant arrhythmia; 13. Refuse to participate in the experiment.

Design outcomes

Secondary

MeasureTime frame
perioperative hidden blood loss;intraoperative blood loss;postoperative blood loss;postoperative changes in HB levels;length of hospital stay;Adverse events such as wound infection and hematoma;Related thromboembolic events and death were;

Primary

MeasureTime frame
Blood Transfusion Rate ;total blood loss;

Countries

China

Contacts

Public ContactYunfeng Rui

Department of Orthopaedics, Zhongda Hospital, School of Medicine, Southeast University, No. 87 Ding Jia Qiao, Nanjing 210009, Jiangsu Province, China.

ruiyunfeng@126.com+86 137 0518 2577

Outcome results

None listed

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