Osteoarthrosis Clinical Trial
Official title:
TOPICAL AND INTRAVENOUS ADMINISTRATION OF TRANEXAMIC ACID ARE EQUALLY EFFECTIVE IN DIRECT ANTERIOR TOTAL HIP ARTHROPLASTY - A PROSPECTIVE RANDOMIZED CONTROLLED TRIAL
Verified date | February 2016 |
Source | Ziekenhuis Oost-Limburg |
Contact | n/a |
Is FDA regulated | No |
Health authority | Belgium: Ethics Committee |
Study type | Interventional |
Through a randomized controlled trial, we will compare the intravenous administration of
tranexamic acid with the intra-articular application after a total hip arthroplasty through
direct anterior approach.
- RCT, prospective study
- Academic-monocentric study
- Clinical outcome measurements The postoperative blood loss will be the primary outcome.
Secondary outcomes are
1. The rate of perioperative and postoperative blood transfusion
2. The number of blood units transfused
3. The length of hospital stay
4. Perioperative given intravenous isotonic fluid
The Null-hypothesis is that there is no significant difference in postoperative blood loss
between intra-articular and intravenous administration of TXA.
Status | Completed |
Enrollment | 120 |
Est. completion date | November 2015 |
Est. primary completion date | November 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - All adults (patients over the age of eighteen years) who were scheduled for a primary unilateral total hip arthroplasty due to osteoarthritis at Ziekenhuis Oost-Limburg, Genk, Belgium are eligible for inclusion in the study. Exclusion Criteria: - History of coagulopathy - Allergy to tranexamic acid - preoperative anemia - fibrinolytic disorders - history of arterial or venous thromboembolic disease - disturbances of color vision - pregnancy - breastfeeding - major comorbidities - participation in another clinical trial |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Belgium | Ziekenhuis Oost-Limburg | Genk | Limburg |
Lead Sponsor | Collaborator |
---|---|
Ziekenhuis Oost-Limburg |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Preoperative hemoglobin level | Measured with a simple blood sample | The day before the surgery | No |
Primary | Postoperative Bloodloss | Measured with a simple blood sample on day one after surgery | Day 1 after surgery | No |
Secondary | Rate of perioperative and postoperative blood transfusion | Patients will be followed for the duration of hospital stay, an expected average of 5 days | No | |
Secondary | Number of blood units transfused | Patients will be followed for the duration of hospital stay, an expected average of 5 days | No | |
Secondary | Length of hospital stay | Measured when patient goes home, minimum 5 days after surgery | No | |
Secondary | Severity of pain at rest as determined with use of a visual analog scale | possible range 0 to 10 | Patients will be followed for the duration of hospital stay, an expected average of 5 days | No |
Secondary | Perioperatively given intravenous isotonic fluid | Done for calculation of the factor dilution after surgery | Patients will be followed for the duration of hospital stay, an expected average of 5 days | No |
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