Post Operative Blood Loss
Conditions
Keywords
Blood Loss, Tranexamic Acid, Total Hip Arthroplasty, Post Op, Post Operative, Prevent Post Operative Blood Loss
Brief summary
Total hip arthroplasty (THA) is a procedure associated with perioperative blood loss, requiring blood transfusions in some patients. The major cause of this blood loss is due to surgical trauma that induces the clotting cascade and fibrinolysis. Several previous studies and meta-analyses have shown that tranexamic acid is an effective antifibrinolytic agent that reduces blood loss in a variety of situations. Tranexamic acid given in an intravenous form has been extensively studied and shown to be efficacious in cardiothoracic, spine surgical procedures as well as total knee arthroplasty (TKA) and THA. Similarly, topical tranexamic acid has been associated with decreased blood loss in cardiac surgeries as well. Recently, results from a prospective randomized study on the topical use of tranexamic acid in total knee arthroplasty found it to be effective for reducing postoperative blood loss. Taking all of the above into consideration we have proposed a study to evaluate effects of topical application of tranexamic acid on postoperative blood loss and blood transfusion on patients undergoing total hip arthroplasty. The aim of this study is to evaluate the efficacy of the topical application of tranexamic acid on blood loss in patients undergoing a primary unilateral total hip arthroplasty.
Interventions
DRUGTranexamic Acid
Tranexamic Acid 1.5 g (100 mg/mL)in 100cc normal saline is applied topically to the wound for 5 minutes time then suctioned and the skin closed. The control group receives just normal saline and no drug.
DRUGNormal Saline Solution
Sponsors
Northwell Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* 18-80 years of age. * Male or female. * Degenerative joint disease of hip joint. * Primary uncemented total hip arthroplasty. * Willingness to participate in the study, follow up at regular intervals
Exclusion criteria
* Known allergy to tranexamic acid * History of any acquired disturbances of color vision * Preoperative anemia on basis of pre-operative lab work up (a hemoglobin value of \<11 g/dL in females and \<12 g/dL in males) * History of previous myocardial infarction * History of arterial or venous thromboembolic disease * History of fibrinolytic disorders requiring intraoperative antifibrinolytic treatment, coagulopathy in the past and/or as identified by a preoperative platelet count of \<150,000/mm3, an international normalized ratio of \>1.5, or a prolonged partial thromboplastin time * Pregnancy (h/o any missed menstrual periods in a women of reproductive age group) * Breastfeeding * Refusal of blood products * Preoperative use of anticoagulant therapy within five days before surgery * Medical issues that may pose complications for surgery and would disqualify patient for surgery regardless of clinical trial (e.g. renal and hepatic failure) * Major comorbidities (e.g. severe ischemic heart disease ) * Severe pulmonary disease * Preoperative blood donation * Participation in another clinical trial involving pharmaceutical drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Estimated Blood Loss | Pre Op, Post Op Day 2 | Estimated Blood Loss defined as Pre Op Hgb mins the Post Op Day two Hgb. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mid Thigh Circumference | Pre Op | Measurement of the thigh at the half way point between the prominence of the greater trochanter and the lateral epicondyle of the femur. No data recorded at 2 weeks or 6 weeks for this study population. |
| Harris Hip Scores | Preoperative | Standardized questionnaire that measures clinical function related to the hip. Total potential range is from 4.0 - 96.0. A higher score indicates a more favorable clinical outcome. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Baseline population, Groups are as follows:
Group 1 (Normal Saline Solution) Patients undergo primary total hip arthroplasty and have a wash of 100cc of normal saline applied to the tissues under the skin prior to skin closure. The wash sits in the wound for 5 minutes then is suctioned out and the skin is closed.
Group 2 (Tranexamic Acid) Patients undergo primary total hip arthroplasty and have a wash of 100cc of normal saline plus 1.5 g (100 mg/mL)Tranexamic Acid is applied to the tissues under the skin prior to skin closure. The wash sits in the wound for 5 minutes then is suctioned out and the skin is closed.
Tranexamic Acid: Tranexamic Acid 1.5 g (100 mg/mL)in 100cc normal saline is applied topically to the wound for 5 minutes time then suctioned and the skin closed. The control group receives just normal saline and no drug.
Since only blinded and deidentified data is available, Baseline measures will be reported on the entire population. | 41 |
| Total | 41 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 12 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants |
| Age, Continuous | 59.6 Years STANDARD_DEVIATION 9.44 |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 19 | 0 / 22 |
| serious Total, serious adverse events | 0 / 19 | 0 / 22 |
Outcome results
Primary
Estimated Blood Loss
Estimated Blood Loss defined as Pre Op Hgb mins the Post Op Day two Hgb.
Time frame: Pre Op, Post Op Day 2
Population: Patients undergoing primary unilateral THA. Group membership is unknown as only data available is blinded and de-identified.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline Population | Estimated Blood Loss | 2.93 Hemoglobin (grams/deciliter) | Standard Deviation 0.77 |
Secondary
Harris Hip Scores
Standardized questionnaire that measures clinical function related to the hip. Total potential range is from 4.0 - 96.0. A higher score indicates a more favorable clinical outcome.
Time frame: Preoperative
Population: Patients undergoing primary total hip arthroplasty.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline Population | Harris Hip Scores | 58.34 units on a scale | Standard Deviation 17.66 |
Secondary
Harris Hip Scores
Standardized questionnaire that measures clinical function related to the hip. Total potential range is from 4.0 - 96.0. A higher score indicates a more favorable clinical outcome.
Time frame: 2 week
Population: Patients undergoing primary total hip arthroplasty.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline Population | Harris Hip Scores | 65.76 units on a scale | Standard Deviation 20.8 |
Secondary
Harris Hip Scores
Standardized questionnaire that measures clinical function related to the hip. Total potential range is from 4.0 - 96.0. A higher score indicates a more favorable clinical outcome.
Time frame: 6 week
Population: Patients undergoing primary total hip arthroplasty.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline Population | Harris Hip Scores | 81.77 units on a scale | Standard Deviation 16.28 |
Secondary
Mid Thigh Circumference
Measurement of the thigh at the half way point between the prominence of the greater trochanter and the lateral epicondyle of the femur. No data recorded at 2 weeks or 6 weeks for this study population.
Time frame: Pre Op
Population: Patients undergoing primary unilateral THA.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline Population | Mid Thigh Circumference | 52.99 centimeters | Standard Deviation 6.32 |