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Trial record 89 of 419 for:    TRANEXAMIC ACID

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

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ClinicalTrials.gov Identifier: NCT02164565
Recruitment Status : Withdrawn (Enrollment difficulties)
First Posted : June 16, 2014
Last Update Posted : August 16, 2017
Sponsor:
Information provided by (Responsible Party):
HaEmek Medical Center, Israel

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

Condition or disease Intervention/treatment Phase
Femur Surgery Drug: Tranexamic Acid (TXA) treatment Drug: control grup: without Tranexamic Acid (TXA) treatment. Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Use of Tranexamic Acid (TXA) Intravenously, to Reduce Blood Loss in Proximal Femur Surgery
Study Start Date : June 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: Tranexamic Acid (TXA) treatment
Tranexamic Acid (TXA) treatment
Drug: Tranexamic Acid (TXA) treatment
Tranexamic Acid (TXA) treatment

Experimental: control grup: without Tranexamic Acid (TXA) treatment.
control grup: without Tranexamic Acid (TXA) treatment.
Drug: control grup: without Tranexamic Acid (TXA) treatment.
control grup: without Tranexamic Acid (TXA) treatment.




Primary Outcome Measures :
  1. Evaluation of blood loss in ml. [ Time Frame: up to 13 months ]

    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




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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02164565


Locations
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Israel
Orthopedic Department, HaEmek Medical Center
Afula, Israel, 18101
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
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Principal Investigator: Nimrod Rozen, Prof. Division of Orthopedic & Rehabilitatio, HaEmek Medical Center

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Responsible Party: HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT02164565     History of Changes
Other Study ID Numbers: 104-12-EMC
First Posted: June 16, 2014    Key Record Dates
Last Update Posted: August 16, 2017
Last Verified: August 2017
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants