Evaluation of the Pharmacokinetic Profile of Tranexamic Acid, After Injection in a Knee Neo-articulation.

NCT02319915 | Completed Early Phase 1

• 1 other identifier: CHUB-PTGexacyl-001
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate the pharmacokinetic profile of tranexamic acid injected intra-articularly with or without adrenaline, in a population of patients undergoing knee replacement.

Conditions

Knee Prosthesis

Keywords

tranexamic acid; knee prosthesis; pharmacokinetic profile

Outcome Measures

Primary Outcomes (1)

• The pharmacokinetic profile of tranexamic acid

  Blood sampling will be performed to establish the pharmacokinetic profile of tranexamic acid. T0 will be defined as the injection time of tranexamic acid. The first blood sampling (T1) will be made 5 minutes after, with the garrot still in place. The garrot will then be loosened and the following blood samplings will take place at 1 minute, 5 minute, 15 minutes, 30 minutes, 1h, 2h, 4h, 8h, 12h and 24h after garrot loosening. 1ml of blood will be taken at each blood sampling. The blood will be placed in a tube suited for chemistry analysis (green tube with gel) and sent directly to the laboratory for analysis.

  24h

Secondary Outcomes (4)

• Knee diameter

  12h

• Net weight of the compresses

  12h

• Size of the blood stain on the band aid

  12h

• Blood loss

  72h

Study Arms (2)

Tranexamic acid

EXPERIMENTAL

Study of the pharmacokinetic profile of the plasmatic resorption of tranexamic acid after an intra-articular injection.

Drug: Tranexamic Acid

Tranexamic acid + adrenalin

ACTIVE COMPARATOR

Study of the pharmacokinetic profile of the plasmatic resorption of tranexamic acid after an intra-articular injection of tranexamic acid with adrenalin 1/200 000.

Drug: Tranexamic Acid; Drug: Adrenalin

Interventions

Tranexamic Acid DRUG

Tranexamic acid; Tranexamic acid + adrenalin

Adrenalin DRUG

Tranexamic acid + adrenalin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• programmed PTG, right or left
• surgery planned within the CHU Brugmann Hospital (Dr Reynders)
• ASA I to ASA III
• Signed informed consent within the patient file

You may not qualify if:

• re-do surgery
• urgent or multiple surgery
• ASA IV or higher
• Patients with a BMI superior or equal to 40
• Patient is a Jehovah Witness
• Allergy or contra-indication to tranexamic acid
• Coagulation troubles, defined as: Platelet count \< 80 000/mm3 and/or PTT \<70% and/or aPTT \>45s and/or Fibrinogen \<100mg/dL
• Preoperatory renal insufficiency defined as Creatinin \> 3mg/dL and/or Dialysis patients.

Sponsors & Collaborators

• Brugmann University Hospital: lead

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

Location

Related Publications (8)

• Gandhi R, Evans HM, Mahomed SR, Mahomed NN. Tranexamic acid and the reduction of blood loss in total knee and hip arthroplasty: a meta-analysis. BMC Res Notes. 2013 May 7;6:184. doi: 10.1186/1756-0500-6-184.

  PMID: 23651507 BACKGROUND

• Chareancholvanich K, Siriwattanasakul P, Narkbunnam R, Pornrattanamaneewong C. Temporary clamping of drain combined with tranexamic acid reduce blood loss after total knee arthroplasty: a prospective randomized controlled trial. BMC Musculoskelet Disord. 2012 Jul 20;13:124. doi: 10.1186/1471-2474-13-124.

  PMID: 22817651 BACKGROUND

• Ortega-Andreu M, Perez-Chrzanowska H, Figueredo R, Gomez-Barrena E. Blood loss control with two doses of tranexamic Acid in a multimodal protocol for total knee arthroplasty. Open Orthop J. 2011 Mar 16;5:44-8. doi: 10.2174/1874325001105010044.

  PMID: 21552468 BACKGROUND

• Charoencholvanich K, Siriwattanasakul P. Tranexamic acid reduces blood loss and blood transfusion after TKA: a prospective randomized controlled trial. Clin Orthop Relat Res. 2011 Oct;469(10):2874-80. doi: 10.1007/s11999-011-1874-2. Epub 2011 Apr 22.

  PMID: 21512813 BACKGROUND

• Mutsuzaki H, Ikeda K. Intra-articular injection of tranexamic acid via a drain plus drain-clamping to reduce blood loss in cementless total knee arthroplasty. J Orthop Surg Res. 2012 Sep 29;7:32. doi: 10.1186/1749-799X-7-32.

  PMID: 23020868 BACKGROUND

• Sa-Ngasoongsong P, Channoom T, Kawinwonggowit V, Woratanarat P, Chanplakorn P, Wibulpolprasert B, Wongsak S, Udomsubpayakul U, Wechmongkolgorn S, Lekpittaya N. Postoperative blood loss reduction in computer-assisted surgery total knee replacement by low dose intra-articular tranexamic acid injection together with 2-hour clamp drain: a prospective triple-blinded randomized controlled trial. Orthop Rev (Pavia). 2011;3(2):e12. doi: 10.4081/or.2011.e12. Epub 2011 Jun 29.

  PMID: 22053253 BACKGROUND

• Ishida K, Tsumura N, Kitagawa A, Hamamura S, Fukuda K, Dogaki Y, Kubo S, Matsumoto T, Matsushita T, Chin T, Iguchi T, Kurosaka M, Kuroda R. Intra-articular injection of tranexamic acid reduces not only blood loss but also knee joint swelling after total knee arthroplasty. Int Orthop. 2011 Nov;35(11):1639-45. doi: 10.1007/s00264-010-1205-3. Epub 2011 Jan 21.

  PMID: 21253725 BACKGROUND

• Samama CM, Langeron O, Rosencher N, Capdevila X, Rouche P, Pegoix M, Berniere J, Coriat P. Aprotinin versus placebo in major orthopedic surgery: a randomized, double-blinded, dose-ranging study. Anesth Analg. 2002 Aug;95(2):287-93, table of contents. doi: 10.1097/00000539-200208000-00005.

  PMID: 12145035 BACKGROUND

MeSH Terms

Interventions

Tranexamic Acid; Epinephrine

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Ethanolamines; Amino Alcohols; Alcohols; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Philippe Van der Linden, MD, Pr

  CHU Brugmann

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pr, MD, Head of clinic

Study Record Dates

• First Submitted: December 15, 2014
• First Posted: December 18, 2014
• Study Start: February 18, 2015
• Primary Completion: March 14, 2017
• Study Completion: March 14, 2017
• Last Updated: January 19, 2018

Record last verified: 2018-01

Locations

BE (1)