Tranexamic Acid in Chinese Elderly Patients With Intertrochanteric Fracture RCT

NCT04290884 | Unknown Phase 4 FDA Drug

• 1 other identifier: UW 18-038
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Hip fracture posed a major challenge to the health care system, with the one-year mortality of hip fracture reported as being approximately 20%. Perioperative haemoglobin level was associated with functional level of the patient and even mortality. 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.

Conditions

Fracture of Femur

Keywords

elderly; intertrochanteric fracture

Outcome Measures

Primary Outcomes (2)

• Transfusion rate

  The total blood transfusion post operation

  Day 3 post operation

• Blood loss

  Blood loss calculation according to formula of Nadler, Hidalgo and Bloch

  Day 3 post operation

Secondary Outcomes (2)

• 3 months mortality rate

  from post operation to 3 months

• Complications

  from post operation to 3 months

Study Arms (2)

Local administration of tranexamic acid

EXPERIMENTAL

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

Drug: Tranexamic Acid

Control group

NO INTERVENTION

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

Interventions

Tranexamic Acid DRUG

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.

Also known as: Transamin

Local administration of tranexamic acid

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults over the age of 60
• Acute isolated intertrochanteric fracture and sub trochanteric fracture treated with short proximal femoral nailing

You may not qualify if:

• Use of any anticoagulant at the time of admission
• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital, The University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (7)

• Schneider EL, Guralnik JM. The aging of America. Impact on health care costs. JAMA. 1990 May 2;263(17):2335-40.

  PMID: 2109105 BACKGROUND

• 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.

  PMID: 20850741 BACKGROUND

• 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.

  PMID: 18349013 BACKGROUND

• 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.

  PMID: 14641869 BACKGROUND

• 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.

  PMID: 28538384 BACKGROUND

• 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.

  PMID: 26978136 BACKGROUND

• 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.

  PMID: 27235515 BACKGROUND

MeSH Terms

Conditions

Femoral Fractures; Hip Fractures

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries; Hip Injuries

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: March 2, 2020
• Study Start: May 23, 2018
• Primary Completion: February 14, 2020
• Study Completion: May 1, 2020
• Last Updated: March 19, 2020

Record last verified: 2020-03

Locations

HK (1)