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

NCT03157401 | Completed DMC

• 1 other identifier: TengzhouCPH_01
• Study Type: observational
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Total Hip Arthroplasty

Outcome Measures

Primary Outcomes (1)

• hidden blood loss

  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).

  at postoperative 1 and 3 days

Secondary Outcomes (1)

• Dominant blood loss

  at intraoperative, postoperative 1 and 3 days

Study Arms (3)

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

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

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

Interventions

intravenous infusion group DRUG

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.

Also known as: tranexamic acid intravenous infusion group

intravenous infusion group

intra-articular injection group DRUG

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.

Also known as: tranexamic acid intra-articular injection group

intra-articular injection group

control group DRUG

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.

Also known as: physiological saline group

control group

Eligibility Criteria

• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tengzhou Central People's Hospital: lead

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Zhenyang Hou, Master

  Tengzhou Central People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: May 17, 2017
• Study Start: April 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2017
• Last Updated: February 9, 2018

Record last verified: 2018-02