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The Use of Tranexamic Acid (TXA) Intravenously, to Reduce Blood Loss in Proximal Femur Surgery
1 other identifier
interventional
N/A
1 country
1
Brief Summary
The use of Tranexamic Acid (TXA) intravenously, to Reduce Blood Loss in proximal femur surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2014
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2014
CompletedStudy Start
First participant enrolled
June 1, 2014
CompletedFirst Posted
Study publicly available on registry
June 16, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedAugust 16, 2017
August 1, 2017
7 months
May 29, 2014
August 13, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Tranexamic Acid (TXA) treatment
EXPERIMENTALTranexamic Acid (TXA) treatment
control grup: without Tranexamic Acid (TXA) treatment.
EXPERIMENTALcontrol grup: without Tranexamic Acid (TXA) treatment.
Interventions
control grup: without Tranexamic Acid (TXA) treatment.
Eligibility Criteria
You may qualify if:
- Patients over 60, who came to the orthopedic department for proximal femur fracture surgery
- Sound judgment
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Orthopedic Department, HaEmek Medical Center
Afula, 18101, Israel
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nimrod Rozen, Prof.
Division of Orthopedic & Rehabilitatio, HaEmek Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2014
First Posted
June 16, 2014
Study Start
June 1, 2014
Primary Completion
January 1, 2015
Study Completion
March 1, 2015
Last Updated
August 16, 2017
Record last verified: 2017-08