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

NCT01260818 | Unknown DMC

• 1 other identifier: GZTCM-201001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hip Replacement; Postoperative Hemorrhage

Keywords

Tranexamic Acid

Outcome Measures

Primary Outcomes (1)

• Blood loss as calculated from change in haematocrit

  7 days

Secondary Outcomes (6)

• Intra-operative blood loss

  1 day

• Postoperative blood loss

  postoperative 4 hours, 1 day, 2 days, 7days respectively

• Hemoglobin levels

  postoperative 4 hours, 1 day, 2 days, 7days respectively

• drainage volume

  postoperative 1 day, 2 days

• Proportion of patients receiving transfusions

  7 days

Study Arms (2)

Tranexamic Acid

EXPERIMENTAL

Drug: Tranexamic Acid

control group

PLACEBO COMPARATOR

Drug: normal saline

Interventions

Tranexamic Acid DRUG

1 g Tranexamic Acid mixed with 100ml saline are kept in wound for 2 hours before drainage is opened postoperatively

Tranexamic Acid

normal saline DRUG

100ml saline is kept in wound for 2 hours before drainage is opened postoperatively

control group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine: lead

Study Sites (1)

the First Affiliated Hospital of Guangzhou TCM University

Guangzhou, Guangdong, 510405, China

RECRUITING

MeSH Terms

Conditions

Postoperative Hemorrhage

Interventions

Tranexamic Acid; Saline Solution

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Yong Li

  The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 14, 2010
• First Posted: December 15, 2010
• Study Start: December 1, 2010
• Primary Completion: December 1, 2011
• Last Updated: December 1, 2011

Record last verified: 2010-12

Locations

CN (1)