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The Use of Tranexamic Acid (TXA) Intravenously, to Reduce Blood Loss in Proximal Femur Surgery

The Use of Tranexamic Acid (TXA) Intravenously, to Reduce Blood Loss in Proximal Femur Surgery

Status
Withdrawn
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02164565
Enrollment
0
Registered
2014-06-16
Start date
2014-06-30
Completion date
2015-03-31
Last updated
2017-08-16

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

Conditions

Femur Surgery

Brief summary

The use of Tranexamic Acid (TXA) intravenously, to Reduce Blood Loss in proximal femur surgery.

Interventions

Tranexamic Acid (TXA) treatment

DRUGcontrol grup: without Tranexamic Acid (TXA) treatment.

control grup: without Tranexamic Acid (TXA) treatment.

Sponsors

HaEmek Medical Center, Israel
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients over 60, who came to the orthopedic department for proximal femur fracture surgery * Sound judgment

Exclusion criteria

* Known hypersensitivity to Tranexamic Acid or component solution provided * Subarachnoid hemorrhage * Acquired color blindness * Myocardial infarction in 12 months before admission * Unstable angina * Known clotting disorders (Thromboembolic disease in the past, elongated PT and PTT, hypercoagulability), * Kidney or liver failure * Another situation prostate resection , pathologic fractures according to anamnesis or by imaging * Oncology patients * Patients on anticoagulation * Patients undergoing vascular intervention ( coronary or peripheral ), which was inserted Supporter requires a Dual antiplatelet therapy

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of blood loss in ml.up to 13 monthsHbloss=BV X (Hbi - Hbe) X 0.001 + Hbt Hbi - hemoglobin level before the surgery ) gram X liter-1(. Hbe - hemoglobin level 3 days after the surgery ( gram X liter-1). Hbt - The amount of hemoglobin that was given in the blood transfusion (gram). Hbloss - Change of hemoglobin loss. After calculating the amount of loss of hemoglobin, the volume of blood lost can be found: Blood loss = 1000 X Hbloss/ Hbi Evaluation of blood loss will be through: 1\. Comparing hemoglobin level before and after surgery and calculation of quantitative Change of hemoglobin loss. 2 .Registration evaluating blood loss at the end of surgery 3. Collecting and recording blood drain. 4. Tracking Blood Transfusion. Of course we collect the data: assessment of bleeding in the analysis, the number of blood units given, the amount of blood collected drain

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026