Hip ReplacementNCT01260818
Topical Application of Tranexamic Acid Reduces Postoperative Blood Loss in Total Hip Arthroplasty
A study testing Tranexamic Acid and normal saline in people with Hip Replacement and Postoperative Hemorrhage, run by The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hip Replacement, Postoperative Hemorrhage
- What is being tested?
- Tranexamic Acid and normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Dec 2010to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient who are to undergo elective total hip arthroplasty.
- Must be primary arthroplasty.
- Must be single-side arthroplasty.
- Must be older than 18 years.
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital of Guangzhou TCM University
Guangzhou, Guangdong, 510405
Yong Li, 86-02036591743, liyong1949@gmail.com
About this study
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
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
- Being tested
- Tranexamic Acid, normal saline
- Keywords
- Tranexamic Acid
- Medical subject headings
- Postoperative Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
1 g Tranexamic Acid mixed with 100ml saline are kept in wound for 2 hours before drainage is opened postoperatively
normal salineDrug
100ml saline is kept in wound for 2 hours before drainage is opened postoperatively
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic Acid | Experimental | Not described Receives: Drug: Tranexamic Acid |
| control group | Placebo comparator | Not described Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood loss as calculated from change in haematocrit
Measured: 7 days
Secondary outcomes (6)
Intra-operative blood loss
Measured: 1 day
Postoperative blood loss
Measured: postoperative 4 hours, 1 day, 2 days, 7days respectively
Hemoglobin levels
Measured: postoperative 4 hours, 1 day, 2 days, 7days respectively
drainage volume
Measured: postoperative 1 day, 2 days
Proportion of patients receiving transfusions
Measured: 7 days
Incidence of deep vein thrombosis postoperatively
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip ReplacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Investigators
- Yong Li, Principal investigator, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01260818
- Sponsor's protocol ID
- GZTCM-201001
- Status last verified
- Dec 2010
- First submitted
- 14 Dec 2010
- Last updated
- 1 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01260818
- Acronym / sponsor ID
- GZTCM-201001
- Conditions
- Hip Replacement, Postoperative Hemorrhage
- Keywords
- Tranexamic Acid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital, Guangzhou University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Dec 2011 (estimated)
- First posted
- 15 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic Acid | Experimental | Drug: Tranexamic Acid |
| control group | Placebo comparator | Drug: normal saline |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient who are to undergo elective total hip arthroplasty.
- Must be primary arthroplasty.
- Must be single-side arthroplasty.
- Must be older than 18 years.
Key exclusion criteria (10 listed)
- 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%).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic Acid1 g Tranexamic Acid mixed with 100ml saline are kept in wound for 2 hours before drainage is opened postoperatively | Drug | Tranexamic Acid |
| normal saline100ml saline is kept in wound for 2 hours before drainage is opened postoperatively | Drug | control group |
Primary outcome
Blood loss as calculated from change in haematocrit
Time frame: 7 days
6 secondary outcomes
Intra-operative blood loss
Time frame: 1 day
Postoperative blood loss
Time frame: postoperative 4 hours, 1 day, 2 days, 7days respectively
Hemoglobin levels
Time frame: postoperative 4 hours, 1 day, 2 days, 7days respectively
drainage volume
Time frame: postoperative 1 day, 2 days
Proportion of patients receiving transfusions
Time frame: 7 days
Incidence of deep vein thrombosis postoperatively
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
the First Affiliated Hospital of Guangzhou TCM University
Guangzhou, China
Yong Li principal investigator
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tranexamic Acid and normal saline in people with Hip Replacement and Postoperative Hemorrhage, run by The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood loss as calculated from change in haematocrit (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2011.