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Trial record 17 of 34 for:    "Collagen Disease" | "Tranexamic Acid"

Topical and Intravenous Administration of TXA Are Equally Effective in DAA THA

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ClinicalTrials.gov Identifier: NCT01940692
Recruitment Status : Completed
First Posted : September 12, 2013
Last Update Posted : February 5, 2016
Sponsor:
Information provided by (Responsible Party):
Jacobs Brecht, Ziekenhuis Oost-Limburg

Brief Summary:

Through a randomized controlled trial, we will compare the intravenous administration of tranexamic acid with the intra-articular application after a total hip arthroplasty through direct anterior approach.

  • RCT, prospective study
  • Academic-monocentric study
  • Clinical outcome measurements The postoperative blood loss will be the primary outcome. Secondary outcomes are

    1. The rate of perioperative and postoperative blood transfusion
    2. The number of blood units transfused
    3. The length of hospital stay
    4. Perioperative given intravenous isotonic fluid

The Null-hypothesis is that there is no significant difference in postoperative blood loss between intra-articular and intravenous administration of TXA.


Condition or disease Intervention/treatment Phase
Osteoarthrosis Drug: 1.5g intravenous Exacyl Drug: 3.0g intra-articular Exacyl Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: TOPICAL AND INTRAVENOUS ADMINISTRATION OF TRANEXAMIC ACID ARE EQUALLY EFFECTIVE IN DIRECT ANTERIOR TOTAL HIP ARTHROPLASTY - A PROSPECTIVE RANDOMIZED CONTROLLED TRIAL
Study Start Date : July 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Intravenous tranexamic acid
Will receive 1.5g intravenous tranexamic acid preoperatively
Drug: 1.5g intravenous Exacyl
intravenous administration of 1.5g Exacyl preoperatively

Experimental: Intra-articular tranexamic acid
Will receive 3g intra-articular tranexamic acid after wound closing
Drug: 3.0g intra-articular Exacyl
3g Intra-articular Exacyl administration postoperatively




Primary Outcome Measures :
  1. Postoperative Bloodloss [ Time Frame: Day 1 after surgery ]
    Measured with a simple blood sample on day one after surgery


Secondary Outcome Measures :
  1. Rate of perioperative and postoperative blood transfusion [ Time Frame: Patients will be followed for the duration of hospital stay, an expected average of 5 days ]
  2. Number of blood units transfused [ Time Frame: Patients will be followed for the duration of hospital stay, an expected average of 5 days ]
  3. Length of hospital stay [ Time Frame: Measured when patient goes home, minimum 5 days after surgery ]
  4. Severity of pain at rest as determined with use of a visual analog scale [ Time Frame: Patients will be followed for the duration of hospital stay, an expected average of 5 days ]
    possible range 0 to 10

  5. Perioperatively given intravenous isotonic fluid [ Time Frame: Patients will be followed for the duration of hospital stay, an expected average of 5 days ]
    Done for calculation of the factor dilution after surgery


Other Outcome Measures:
  1. Preoperative hemoglobin level [ Time Frame: The day before the surgery ]
    Measured with a simple blood sample



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All adults (patients over the age of eighteen years) who were scheduled for a primary unilateral total hip arthroplasty due to osteoarthritis at Ziekenhuis Oost-Limburg, Genk, Belgium are eligible for inclusion in the study.

Exclusion Criteria:

  • History of coagulopathy
  • Allergy to tranexamic acid
  • preoperative anemia
  • fibrinolytic disorders
  • history of arterial or venous thromboembolic disease
  • disturbances of color vision
  • pregnancy
  • breastfeeding
  • major comorbidities
  • participation in another clinical trial

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): NCT01940692


Locations
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Belgium
Ziekenhuis Oost-Limburg
Genk, Limburg, Belgium, 3600
Sponsors and Collaborators
Ziekenhuis Oost-Limburg
Investigators
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Principal Investigator: Kristoff Corten, Prof. dr. Ziekenhuis Oost-Limburg

Additional Information:
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Responsible Party: Jacobs Brecht, Medical student, Ziekenhuis Oost-Limburg
ClinicalTrials.gov Identifier: NCT01940692     History of Changes
Other Study ID Numbers: TXA01
First Posted: September 12, 2013    Key Record Dates
Last Update Posted: February 5, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
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Rheumatic Diseases
Tranexamic Acid
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants