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Hemostatic efficacy and safety of preemptive antifibrinolysis with multi-dose tranexamic acid in elderly hip fracture patients- a prospective randomized controlled trial

Hemostatic efficacy and safety of preemptive antifibrinolysis with multi-dose tranexamic acid in elderly hip fracture patients- a prospective randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100054791
Enrollment
Unknown
Registered
2021-12-27
Start date
2022-01-01
Completion date
Unknown
Last updated
2022-12-05

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

Conditions

Hip fractures

Interventions

Group A:100 ml NS i.v. q12h preoperatively
1.5 g TXA i.v. q12h postoperatively for 3 days.
Group B:1.5 g TXA i.v. q12h preoperatively

Sponsors

The First Affiliated Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Over 65 years old; 2.Diagnosed with a primary, unilateral, recent hip fracture (femoral neck fracture or intertrochanteric fracture) by X-ray or CT scan; 3.Receiving hip arthroplasty.

Exclusion criteria

Exclusion criteria: 1.Complicated with multiple fractures or open fractures; 2.Active bleeding (like gastrointestinal bleeding, cerebral haemorrhage, etc); 3.Systematic thromboembolism (DVT, PE, etc); 4.Coagulation dysfunction (such as Preoperative INR >1.4, APTT >1.4 x normal, etc.); 5.Combined with serious neuromuscular diseases; 6.Allergic to TXA. 7.Patients who are dementially reduced or with cognitive dysfunction that cannot give informed consent, or decline to participate.

Design outcomes

Primary

MeasureTime frame
Hidden blood loss (HBL);Decline of hemoglobin level;Transfusion rate;

Secondary

MeasureTime frame
Conventional coagulation indexes (PT, PTR, INR, PTA, APTT, TT);Conventional fibrinolytic indicators (FDP, D-D);Coagulation factors (II, V, VII, VIII, IX, X, XI, XII);Thromboelastogram(TEG);Time from fracture occurrence to admission;Time from admission to surgery;Wound complications (exudation, hematoma, infection);Incidence of thrombosis (deep vein thrombosis, pulmonary embolism);Hospitalization expenses;Length of stay;90-day mortality after surgery;

Countries

China

Contacts

Public ContactHuang Wei

The First Affiliated Hospital of Chongqing Medical University

huangwei68@263.net+86 13883383330

Outcome results

None listed

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