Skip to main content
MedPathMedPath Home
Clinical Trials/ISRCTN58790500
ISRCTN58790500
Completed
Phase 4

Single centre randomised controlled trial to assess the effect of the addition of twenty-four hours of oral tranexamic acid post-operatively to a single intra-operative intravenous dose of tranexamic acid on calculated blood loss following primary hip and knee arthroplasty

The Belfast and Health Social Care Trust (BHSCT)0 sites1,056 target enrollmentJune 21, 2016
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsElective primary hip or knee replacementMusculoskeletal Diseases

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Elective primary hip or knee replacement
Sponsor
The Belfast and Health Social Care Trust (BHSCT)
Enrollment
1056
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30064517 protocol 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34192922/ results for total hip arthroplasty (added 20/01/2022) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34587808/ results for total knee arthroplasty (added 20/01/2022) 2022 Other publications in https://pubmed.ncbi.nlm.nih.gov/35816170/ Cost analysis (added 10/07/2023)

Registry
who.int
Start Date
June 21, 2016
End Date
July 6, 2020
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
The Belfast and Health Social Care Trust (BHSCT)

Eligibility Criteria

Inclusion Criteria

  • •1\. Awaiting primary elective hip or knee replacement
  • •2\. Both male \& female
  • •3\. Aged between 18 and 100 years

Exclusion Criteria

  • •Current participant exclusion criteria as of 28/03/2018:
  • •1\. Patients who do not pass a pre\-operative assessment for elective total hip or knee arthroplasty (THA/TKA)
  • •2\. Fractured neck of femur
  • •3\. Haemophiliac or coagulation disorders that require TXA
  • •4\. Allergy to tranexamic acid or any of its excipients
  • •5\. Platelets \<75,000/mm3 at pre\-operative assessment\*
  • •6\. Patients on active treatment for venous thromboembolism (VTE) (deep vein thrombosis (DVT), pulmonary embolisms (PE)) within 6 months of surgery\*
  • •7\. History of VTE within 6 months of surgery\*
  • •8\. Patients who have had a myocardial infarction (MI) within 12 months\*
  • •9\. Cardiac stent within 12 months of surgery\*

Outcomes

Primary Outcomes

Not specified

Similar Trials

Completed
Not Applicable
Rehabilitation enablement in chronic heart failure
ISRCTN78539530Royal Cornwall Hospitals NHS Trust50
Completed
Not Applicable
A novel human milk fortifier derived from donkey milk for the nutrition of preterm or low-weight newbornsEnteral nutrition in very low birthweight infantsNeonatal Diseases
ISRCTN70022881SC Neonatologia, University of Turin124
Completed
Phase 3
A study comparing pre-hospital administration of packed red blood cells and freeze-dried plasma with administration of normal saline in patients with low blood pressure after major injuriesTraumatic haemorrhageInjury, Occupational Diseases, Poisoning
ISRCTN62326938niversity Hospitals Birmingham NHS Foundation Trust432
Completed
Not Applicable
The Newcastle COPD CBT CARE StudyAnxiety, depression, respiratory.Mental and Behavioural Disorders
ISRCTN55206395ational Institute of Health Research (UK)312
Completed
Not Applicable
The treatment of severe atopic eczema trial (TREAT)Topic: Children, DermatologySubtopic: Children (all Diagnoses), Dermatology (Skin)Disease: All Diseases, DermatologySkin and Connective Tissue DiseasesSevere atopic eczema
ISRCTN15837754King's College London (UK)103