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

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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100045960
Enrollment
Unknown
Registered
2021-04-30
Start date
2021-06-01
Completion date
Unknown
Last updated
2021-12-13

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:NS 100ml i.v. q12h, before surgery
1.5g TXA i.v. q12h, the first 3 days following surgery.
Group B:1.5g TXA i.v. q12h, before surgery

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.Aged over 65 years; 2.Diagnosed with a primary, unilateral, recent hip fracture (femoral neck fracture or intertrochanteric fracture) by X-ray or CT scan; 3.Receiving hemi- or total hip arthroplasty.

Exclusion criteria

Exclusion criteria: 1. Cognitive dysfunction, inability to obtain informed consent, or rejection of participants; 2. Multiple fractures or open fractures; 3. Active bleeding (such as active gastrointestinal bleeding, cerebral hemorrhage, etc.); 4. Systemic thromboembolism (deep vein thrombosis, pulmonary embolism, etc.); 5. Coagulation dysfunction; 6. Severe neuromuscular disease; 7. Allergic to tranexamic acid.

Design outcomes

Primary

MeasureTime frame
Total blood loss;Hidden blood loss;Dominant blood loss;Decline of hemoglobin;Allogeneic blood transfusion rate;

Secondary

MeasureTime frame
Inflammatory factor (ESR, CRP, PCT, IL-6, IL-8, IL-10, TNF-a);Coagulation and fibrinolysis indicators (PT, PTR, INR, PTA, APTT, TT, Fbg, FDP, D-D);Coagulation factors (II, V, VII, VIII, IX, X, XI, XII);Thromboelastogram(TEG);Time from fracture occurrence to surgery;Time form admittance to surgery;Wound complications (exudation, hematoma, infection);Length of stay;90-day mortality;Incidence of venous thromboembolism (DVT, PE);Hospitalization expenses;

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 13, 2026