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

Primary Purpose

Hip Replacement, Postoperative Hemorrhage

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Tranexamic Acid

normal saline

About this trial

This is an interventional treatment trial for Hip Replacement focused on measuring Tranexamic Acid

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

the First Affiliated Hospital of Guangzhou TCM UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tranexamic Acid

control group

Arm Description

Outcomes

Primary Outcome Measures

Blood loss as calculated from change in haematocrit

Secondary Outcome Measures

Intra-operative blood loss

Postoperative blood loss

Hemoglobin levels

drainage volume

Proportion of patients receiving transfusions

Incidence of deep vein thrombosis postoperatively

Full Information

NCT ID

NCT01260818

First Posted

December 14, 2010

Last Updated

November 30, 2011

Sponsor

The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

1. Study Identification

Unique Protocol Identification Number

NCT01260818

Brief Title

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

Official Title

Prospective Randomized Trial Comparing Topical Tranexamic Acid Plus Standard Of Care Versus Standard Of Care For The Reduction Of Blood Loss Following Primary Total Hip Arthroplasty Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

December 2010

Overall Recruitment Status

Unknown status

Study Start Date

December 2010 (undefined)

Primary Completion Date

December 2011 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hip Replacement, Postoperative Hemorrhage

Keywords

Tranexamic Acid

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Tranexamic Acid

Arm Type

Experimental

Arm Title

control group

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Tranexamic Acid

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

normal saline

Intervention Description

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

Primary Outcome Measure Information:

Title

Blood loss as calculated from change in haematocrit

Time Frame

7 days

Secondary Outcome Measure Information:

Title

Intra-operative blood loss

Time Frame

1 day

Title

Postoperative blood loss

Time Frame

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

Title

Hemoglobin levels

Time Frame

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

Title

drainage volume

Time Frame

postoperative 1 day, 2 days

Title

Proportion of patients receiving transfusions

Time Frame

7 days

Title

Incidence of deep vein thrombosis postoperatively

Time Frame

7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yong Li

Organizational Affiliation

The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

the First Affiliated Hospital of Guangzhou TCM University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510405

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yong Li

Phone

86-02036591743

liyong1949@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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