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Hemostatic and anti-inflammatory effects of tranexamic acid combined with carbalosulfonate in patients with intertrochanteric fracture undergoing PFNA : a randomized controlled clinical trial

Hemostatic and anti-inflammatory effects of tranexamic acid combined with carbalosulfonate in patients with intertrochanteric fracture undergoing PFNA : a randomized controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400088060
Enrollment
Unknown
Registered
2024-08-09
Start date
2024-09-01
Completion date
Unknown
Last updated
2024-08-12

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

Conditions

intertrochanteric fracture

Interventions

A:100ml tranexamic acid sodium chloride injection was injected intravenously 5 minutes before surgery. After the completion of pulp dilation and before insertion of intramedullary nail, 50 mL carbamat
B:100ml (1g) of tranexamic acid sodium chloride injection was given intravenously 5 minutes before surgery. After intraoperative pulpal dilation was completed and before intramedullary nail was insert
C:Tranexamic acid sodium chloride injection 100ml (1g) was injected intravenously 5 minutes before surgery. After the pulpal redilation was completed and before intramedullary nail was inserted, 50 mL
D:100ml of tranexamic acid sodium chloride injection (1g) was given intravenously 5 minutes before surgery. After pulpal dilation and before intramedullary nail insertion, 50 mL of 0.9% sodium chlorid

Sponsors

Hospital of Chengdu University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 90 Years

Inclusion criteria

Inclusion criteria: ? Patients with imaging diagnosis of femoral intertrochanteric fracture requiring unilateral PFNA surgery; ? Body mass index (BMI20-35kg/m2) ? The preoperative ASA classification was grade I-III ? Age 60 and above ? There were no significant abnormalities in hemoglobin, coagulation and liver and kidney function before operation.

Exclusion criteria

Exclusion criteria: ? Allergic to tranexamic acid, carbalosulfonate sodium, anesthetic drugs ? non-simple intertrochanteric fracture; Alcoholic or pregnant persons; ? Use anticoagulant drugs or birth control pills 5 days before surgery; ? Old fracture History of thromboembolic disease (i.e., deep vein thrombosis (DVT), or pulmonary embolism (PE)), clotting disease, recent arterial thromboembolic events (e.g., myocardial infarction or stroke), hypercoagulability, hemophilia; Severe cardiovascular and respiratory diseases; Kidney and liver failure, history of kidney transplantation; ? with severe bleeding disease ? Those who refuse to participate in or accept blood products

Design outcomes

Primary

MeasureTime frame
Total Blood Loss;

Secondary

MeasureTime frame
Intraoperative Blood Loss;Hidden Blood Loss;Transfusion rate ;mean operating time;Mean blood pressure;inflammatory makers;VAS score;hospital stays;coagulation indicator;The rate of vein thrombosis ;

Countries

China

Contacts

Public ContactLihan Shi

Hospital of Chengdu University of Traditional Chinese Medicine

shilihan1989@sina.com+86 176 1280 8930

Outcome results

None listed

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