Blood loss in total hip replacement in patient with ostoearthritis and rheumatoid arthritis.
Conditions
Interventions
Trade Name: Cyklokapron®
Product Name: Cyklokapron®
Product Code: NA
Pharmaceutical Form: Injection*
Pharmaceutical form of the placebo: Intravenous infusion
Route of administration of the placebo: L
Sponsors
University Hospital of North Tees and Hartlepool
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Undergoing unilateral primary total hip replacement. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Undergoing unilateral primary total hip replacement for tumour. 2.Allergic to Tranexamic acid. 3.Bleeding tendency (e.g. Haemophilic and platelets disorders). 4.Warfarin, treatment dose of LMWH or conventional heparin). 5.History of DVT and pulmonary embolism. 6.Renal failure with creatinine > 250 micromole/l. 7.Female subjects of child bearing potential must have a negative pregnancy test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To find out whether Tranexamic acid will reduce blood loss and subsequent blood transfusion significantly after total hip replacement when applied topically.;Secondary Objective: •The visible drain blood loss (First 48 hour). •Haemoglobin and Haematocrit drops (On day 2 postoperatively). •General quality of life measure (EUROQOL) •Oxford hip score •Length of stay. •Cost effectiveness analysis. •Complications ;Primary end point(s): Blood transfusion rate and number of blood units transfused until discharge. Based on the recommendation of British Orthopaedic Association , Blood Transfusion Task Force, and The British Committee for Standards in Haematology , UK blood transfusion and tissue transplantation services, our transfusion protocol recommend the following: •Red cell transfusion is not indicated when Haemoglobin concentration is more than 10 g/dl. •Red cell transfusion is indicated when Haemoglobin concentration is < 7 g/dl and red cell transfusion should be given in relation to the rate of red cell loss. In otherwise stable patient, 2 units of red cell should be transfused, and then the clinical situation and Haemoglobin concentration should be reassessed. •The correct strategy for transfusing patients with haemoglobin between 7 and 10 is less clear. Clinicians often transfuse although the available evidence suggest this is not justified. BOA recommends that symptomatic patients should be transfused. Symptoms include fatigue, tiredness, short of breath, palpitation, chest pain, tachycardia and tachypnea. •In patients who tolerate anaemia poorly, example, patients over 65 years or those with cardiovascular diseases or respiratory diseases, consider adopting a higher threshold level for blood transfusion ( when Haemoglobin concentration is 8 g/dl). The Haemoglobin level will be checked the next day after the transfusion and the same protocol is applied if the Haemoglobin level is low. profroma | — |
Countries
United Kingdom
Outcome results
None listed