EUCTR2020-003321-32-DK
Active, not recruiting
Phase 1
Evaluation of intra articular Tranexamic acid for reduction of total blood loss in total hip arthroplasty
Hvidovre Hospital, Dep. of Orthopaedic Surgery0 sites100 target enrollmentJuly 7, 2020
ConditionsThe benefit of additional Tranexamic Acid (TXA) injected intra-articularat the end of surgery for patients undergoing a unilateral total hiparthroplasty in addition to conventional IV TXA to reduce the bleeding.MedDRA version: 20.0Level: LLTClassification code 10003397Term: Arthroplasty of hipSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
DrugsTranexamic acid
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- The benefit of additional Tranexamic Acid (TXA) injected intra-articularat the end of surgery for patients undergoing a unilateral total hiparthroplasty in addition to conventional IV TXA to reduce the bleeding.
- Sponsor
- Hvidovre Hospital, Dep. of Orthopaedic Surgery
- Enrollment
- 100
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\= 18 years
- •Undergoing surgery for unilateral total hip arthroplasty
- •Able to give ones consent either verbally or written.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 40
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 60
Exclusion Criteria
- •\- Operation performed in general anaesthesia
- •\- Allergi to TXA
- •\- In treatment with the following anticoagulatia: ADP receptorinhibitors, vitamin\-K antagonist(within 5\-7 days before the operation). Factor Xa inhibitors, thrombine\-inhibitors
- •\- Use of oral anticonceptiva
- •\- Kown with thrombophilia
- •\- Reduced kidney function (GFR \<60 ml/hour)
- •\- Participated in a clinical trial within the last 30 days
- •\- Alcoholism and morphinism
- •\- Females: menstruation within the last 12 months
- •\- Patients who are not able to speak and understand Danish
Outcomes
Primary Outcomes
Not specified
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