Tranexamic Acid in Chinese Elderly Patients With Intertrochanteric Fracture RCT
NCT ID: NCT04290884
Last Updated: 2020-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
120 participants
INTERVENTIONAL
2018-05-23
2020-05-31
Brief Summary
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Different methods for administration of tranexamic acid had been described. It was well established that systemic administration of tranexamic acid could reduce perioperative blood loss and transfusion rate. Topical administration had been shown to decrease blood loss and transfusion rate.
The objective of our study is to investigate the hypothesis that tranexamic acid will reduce blood loss and transfusion rate in elderly patients undergoing hip fracture surgery.
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Detailed Description
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Tranexamic acid, one of antifibrinolytic agents, is a synthetic derivative of the amino acid lysine and acts as a competitive inhibitor in the activation of plasminogen to plasmin, therefore preventing the degradation of fibrin. Shakur et al. reported that the use could reduce mortality in trauma patients. Tranexamic acid has been widely used in elective orthopaedic surgery such as total joint replacement and spine surgery. Several authors reported that tranexamic acid could decreases the blood loss, transfusion rate and cost.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Local administration of tranexamic acid
1. All patients hip fracture will be treated according to the hospital standard procedure
2. Check complete blood count on admission and Day 3 post-operation.
3. 10ml tranexamic acid injected under the deep fascia around the fracture site under x-ray control
4. Sealed envelope system: Operation room nurse will open a sealed envelope for treatment allocation. The medications are prepared by the nurse according to the instruction inside the envelop.
5. Transfusion when clinically indicated or Hb \< 8g/dL
6. Blood Loss calculation (formula of Nadler, Hidalgo and Bloch)
7. Blood taken at Day 3 post-operation will be used for measure of postoperative haematocrit. By this time postoperatively fluid shift has settled and the patient is haemodynamically stable.
8. After discharge, patients will be seen in 6 weeks and 3 months
Tranexamic Acid
The recruited patients will be randomly assigned to two groups, 50% chance to the experimental group (use of tranexamic acid) and 50% chance to the control group (use of normal saline). After the reduction of the intertrochanteric fracture, 10ml of tranexamic acid is injected under the deep fascia around the fracture area before inserting a drain. As for the control group, 10ml of normal saline is injected instead. Blood will be taken on the third day post operation, and the patient will be seen at 6 weeks, and 3 months.
Control group
1. All patients hip fracture will be treated according to the hospital standard procedure
2. Check complete blood count on admission and Day 3 post-operation.
3. 10ml normal saline injected under the deep fascia around the fracture site under x-ray control
4. Sealed envelope system: Operation room nurse will open a sealed envelope for treatment allocation. The medications are prepared by the nurse according to the instruction inside the envelop.
5. Transfusion when clinically indicated or Hb \< 8g/dL
6. Blood Loss calculation (formula of Nadler, Hidalgo and Bloch)
7. Blood taken at Day 3 post-operation will be used for measure of postoperative haematocrit. By this time postoperatively fluid shift has settled and the patient is haemodynamically stable.
8. After discharge, patients will be seen in 6 weeks and 3 months
No interventions assigned to this group
Interventions
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Tranexamic Acid
The recruited patients will be randomly assigned to two groups, 50% chance to the experimental group (use of tranexamic acid) and 50% chance to the control group (use of normal saline). After the reduction of the intertrochanteric fracture, 10ml of tranexamic acid is injected under the deep fascia around the fracture area before inserting a drain. As for the control group, 10ml of normal saline is injected instead. Blood will be taken on the third day post operation, and the patient will be seen at 6 weeks, and 3 months.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Acute isolated intertrochanteric fracture and sub trochanteric fracture treated with short proximal femoral nailing
Exclusion Criteria
* Documented allergy to tranexamic acid
* History of pulmonary embolism or deep vein thrombosis
* Hepatic failure
* Severe renal insufficiency
* Active coronary artery disease in the past 12 months
* History of cerebrovascular accident in the past 12 months
* Presence of a drug-eluting stent
* Active oncological diseases
* Coagulopathy (international normalised ratio (INR)\>1.4)
* Pathological fractures
* Periprosthetic fractures
* Operation \>2 days from admission
60 Years
ALL
No
Sponsors
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The University of Hong Kong
OTHER
Responsible Party
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Dr. Wong Tak-Man
Clinical Assistant Professor
Locations
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Queen Mary Hospital, The University of Hong Kong
Hong Kong, , Hong Kong
Countries
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References
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Schneider EL, Guralnik JM. The aging of America. Impact on health care costs. JAMA. 1990 May 2;263(17):2335-40.
Bhaskar D, Parker MJ. Haematological indices as surrogate markers of factors affecting mortality after hip fracture. Injury. 2011 Feb;42(2):178-82. doi: 10.1016/j.injury.2010.07.501.
Foss NB, Kristensen MT, Kehlet H. Anaemia impedes functional mobility after hip fracture surgery. Age Ageing. 2008 Mar;37(2):173-8. doi: 10.1093/ageing/afm161.
Lawrence VA, Silverstein JH, Cornell JE, Pederson T, Noveck H, Carson JL. Higher Hb level is associated with better early functional recovery after hip fracture repair. Transfusion. 2003 Dec;43(12):1717-22. doi: 10.1046/j.0041-1132.2003.00581.x.
Zhang P, He J, Fang Y, Chen P, Liang Y, Wang J. Efficacy and safety of intravenous tranexamic acid administration in patients undergoing hip fracture surgery for hemostasis: A meta-analysis. Medicine (Baltimore). 2017 May;96(21):e6940. doi: 10.1097/MD.0000000000006940.
Drakos A, Raoulis V, Karatzios K, Doxariotis N, Kontogeorgakos V, Malizos K, Varitimidis SE. Efficacy of Local Administration of Tranexamic Acid for Blood Salvage in Patients Undergoing Intertrochanteric Fracture Surgery. J Orthop Trauma. 2016 Aug;30(8):409-14. doi: 10.1097/BOT.0000000000000577.
Tengberg PT, Foss NB, Palm H, Kallemose T, Troelsen A. Tranexamic acid reduces blood loss in patients with extracapsular fractures of the hip: results of a randomised controlled trial. Bone Joint J. 2016 Jun;98-B(6):747-53. doi: 10.1302/0301-620X.98B6.36645.
Other Identifiers
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UW 18-038
Identifier Type: -
Identifier Source: org_study_id
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