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Identifying the Optimal Regimen for Intravenous Tranexamic Acid Administration in Hip Fractrues: a Prospective, Randomized, Double-Blind, Controlled Study

Identifying the Optimal Regimen for Intravenous Tranexamic Acid Administration in Hip Fractrues: a Prospective, Randomized, Double-Blind, Controlled Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000032758
Enrollment
Unknown
Registered
2020-05-09
Start date
2020-07-31
Completion date
Unknown
Last updated
2020-05-11

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

Conditions

Hip fracture

Interventions

A:the same amount of normal saline was used Preoperative (before incision), 3 and 6 hours after the operation
B:Tranexamic acid (TXA) was 15mg/kg before surgery (before incision) and the same amount of normal saline 3 and 6 hours after surgery
C:Before surgery (before incision), 3 hours after surgery, tranexamic acid (TXA) was 15mg/kg, and 6 hours after surgery, the same amount of normal saline
D:Before surgery (before incision), 3 and 6 hours after surgery, tranexamic acid (TXA) was 15mg/kg

Sponsors

Trauma Center of Daping Hospital, Army Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Patients with unilateral hip fractures (femoral neck fractures, intertrochanteric and subtrochanteric fractures) who underwent surgical treatment; 2. Patients over 18 years old; 3. There was no abnormality in the color Doppler ultrasound of the lower extremity vein before operation; 4. patients with normal platelet and coagulation function before operation; 5. Patients who voluntarily participate in the clinical trial and sign the informed consent form with good compliance.

Exclusion criteria

Exclusion criteria: 1. Those who are allergic to carbamic acid or who have contraindications; 2. Patients who have been injured for more than 24 hours; 3. Patients with open fracture or pathological fracture or periprosthetic fracture; 4. Patients with multiple trauma or fracture; 5. Patients who took anticoagulants or aspirin for less than 1 week; 6. Patients at high risk of thrombosis, including AF, pacemaker and stent implantation; 7. Patients with history of venous thromboembolism, pulmonary embolism, cerebral infarction and coronary heart disease (within half a year); 8. Patients with abnormal platelet and coagulation (PLT 1.4).

Design outcomes

Primary

MeasureTime frame
Total blood loss;Hidden blood loss;

Secondary

MeasureTime frame
Intraoperative blood loss;Allogeneic blood transfusion rate;Hb level;Hct;Hb drop;Hct drop;Fibrin degradation products;D-Dimer;hospital stay;VTE;

Countries

China

Contacts

Public ContactRan Chen

Trauma Center of Daping Hospital, Army Military Medical University

chenran15@hotmail.com+86 13008135085

Outcome results

None listed

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