Femur Surgery Clinical Trial
Official title:
The Use of Tranexamic Acid (TXA) Intravenously, to Reduce Blood Loss in Proximal Femur Surgery
| Verified date | August 2017 |
| Source | HaEmek Medical Center, Israel |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The use of Tranexamic Acid (TXA) intravenously, to Reduce Blood Loss in proximal femur surgery.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | March 2015 |
| Est. primary completion date | January 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 60 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Israel | Orthopedic Department, HaEmek Medical Center | Afula |
| Lead Sponsor | Collaborator |
|---|---|
| HaEmek Medical Center, Israel |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Evaluation of blood loss in ml. | Hbloss=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 |
up to 13 months |