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Two Different Administration Methods of Tranexamic Acid on Perioperative Blood Loss During Total Hip Arthroplasty

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ClinicalTrials.gov Identifier: NCT03157401
Recruitment Status : Completed
First Posted : May 17, 2017
Last Update Posted : February 9, 2018
Sponsor:
Information provided by (Responsible Party):
neonatal intensive care unit, Tengzhou Central People's Hospital

Brief Summary:
To compare the two administration methods of tranexamic acid for patients undergoing the first unilateral THA, to explore the effects of tranexamic acid on perioperative blood loss from the aspects of dominant blood loss, hidden blood loss, blood transfusion rate, mean blood transfusion volume and safety so as to further clarify what kind of medication is more effective.

Condition or disease Intervention/treatment
Total Hip Arthroplasty Drug: intravenous infusion group Drug: intra-articular injection group Drug: control group

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Effects of Two Different Administration Methods of Tranexamic Acid on Perioperative Blood Loss During Total Hip Arthroplasty: a Prospective, Open-label, Randomized, Controlled Clinical Trial
Actual Study Start Date : April 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Group/Cohort Intervention/treatment
intravenous infusion group
In the tranexamic acid intravenous infusion group (n = 30), 15 mg/kg tranexamic acid diluted in 100 mL physiological saline was intravenously infused at the beginning of the surgery. After suturing deep fascia, 20 mL of physiological saline was intra-articularly injected.
Drug: intravenous infusion group
In the tranexamic acid intravenous infusion group (n = 30), 15 mg/kg tranexamic acid diluted in 100 mL physiological saline was intravenously infused at the beginning of the surgery. After suturing deep fascia, 20 mL of physiological saline was intra-articularly injected.
Other Name: tranexamic acid intravenous infusion group

intra-articular injection group
In the tranexamic acid intra-articular injection group (n = 30), 100 mL of physiological saline was intravenously infused at the beginning of the surgery. After suturing deep fascia, the mixture of 1.5 g tranexamic acid and 20 mL physiological saline was intra-articularly injected.
Drug: intra-articular injection group
In the tranexamic acid intra-articular injection group (n = 30), 100 mL of physiological saline was intravenously infused at the beginning of the surgery. After suturing deep fascia, the mixture of 1.5 g tranexamic acid and 20 mL physiological saline was intra-articularly injected.
Other Name: tranexamic acid intra-articular injection group

control group
In the control group (n = 30), 100 mL of physiological saline was intravenously infused at the beginning of the surgery. After suturing deep fascia, 20 mL of physiological saline was intra-articularly injected.
Drug: control group
In the control group (n = 30), 100 mL of physiological saline was intravenously infused at the beginning of the surgery. After suturing deep fascia, 20 mL of physiological saline was intra-articularly injected.
Other Name: physiological saline group




Primary Outcome Measures :
  1. hidden blood loss [ Time Frame: at postoperative 1 and 3 days ]
    Hidden blood loss was calculated by the circulation volume proposed by Gross, i.e., total erythrocyte loss is equal to preoperative total blood volume × (hematocrit preoperatively - hematocrit postoperatively 3 days).


Secondary Outcome Measures :
  1. Dominant blood loss [ Time Frame: at intraoperative, postoperative 1 and 3 days ]
    Dominant blood loss includes intraoperative blood loss and postoperative blood loss. Intraoperative blood loss was quantified by measuring irrigation fluid and weight measurement of surgical sponges. Postoperative blood loss was quantified by measuring wound drainage volume and weight measurement of surgical sponges.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
To recruit 90 patients undergoing the first unilateral THA at the Tengzhou Central People's Hospital from July 2015 to November 2016. The patients were equally and randomly assigned to three groups.
Criteria

Inclusion Criteria:

  • Femoral head necrosis or femoral neck fracture patients undergoing the first unilateral THA
  • Bilateral hips with indications for THA in patients with femoral head necrosis, but after arthroplasty on one side, the arthroplasty on the other side will be conducted when choosing a good time and physical condition allows.
  • Average age: 62.52 years
  • Sex ratio of males to females: 11:19
  • Signed informed consent

Exclusion Criteria:

  • Coagulation disorders and anemia
  • History of infection on the affected extremity
  • History of vascular embolization and long-term oral anticoagulant drugs
  • Contraindications for tranexamic acid or anticoagulant drugs

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): NCT03157401


Sponsors and Collaborators
Tengzhou Central People's Hospital
Investigators
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Principal Investigator: Zhenyang Hou, Master Tengzhou Central People's Hospital

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Responsible Party: neonatal intensive care unit, Principal Investigator, Tengzhou Central People's Hospital
ClinicalTrials.gov Identifier: NCT03157401     History of Changes
Other Study ID Numbers: TengzhouCPH_01
First Posted: May 17, 2017    Key Record Dates
Last Update Posted: February 9, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants