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Topical Application of Tranexamic Acid Reduces Postoperative Blood Loss in Total Hip Arthroplasty

G

Guangzhou University of Chinese Medicine

Status

Unknown

Conditions

Postoperative Hemorrhage
Hip Replacement

Treatments

Drug: Tranexamic Acid
Drug: normal saline

Study type

Interventional

Funder types

Other

Identifiers

NCT01260818
GZTCM-201001

Details and patient eligibility

About

Tranexamic acid has been shown to reduce postoperative blood losses and transfusion requirements in a number of types of surgery. Most trials in orthopedic surgery have been conducted intravenously in arthroplasty, hip fracture and spine surgeries. This study would aim to see the effect of topical use of tranexamic acid in reduction of blood loss and transfusions for total hip arthroplasty

Enrollment

100 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patient who are to undergo elective total hip arthroplasty.
  • Must be primary arthroplasty.
  • Must be single-side arthroplasty.
  • Must be older than 18 years.

Exclusion criteria

  • Cemented arthroplasty.
  • Patients with a platelet count less than 100, 000/mm3 or history of thrombocytopenia .
  • Patients with known coagulopathy (APTT or PT outside normal range pre-operatively).
  • Patients who have a past medical history of thrombi-embolism at any time.
  • Patients with anemia (hemoglobin levels less than 8 mg/dl or hematocrit <24%).
  • Patients with documented DVT or PE at screening or in past three months.
  • Patients having known hypersensitivity to tranexamic acid or any other. constituent of the product.
  • Patients with any associated major illness (e.g., severe cardiac [New York Heart Association Class III or IV] or respiratory disease).
  • Anticoagulants (other than LMWH or heparin in prophylactic doses to prevent deep vein thrombosis), direct thrombin inhibitors or thrombolytic therapy administered or completed within last week.
  • Jehovah's Witnesses, or any other group of patients with ethical objections to receiving blood products.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

100 participants in 2 patient groups, including a placebo group

Tranexamic Acid
Experimental group
Treatment:
Drug: Tranexamic Acid
control group
Placebo Comparator group
Treatment:
Drug: normal saline

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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