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Fibrin Glue or Tranexamic Acid for Total Knee Arthroplasty (ATRHEMOS)

This study has been completed.
Sponsor:
Collaborator:
Banc de Sang i Teixits
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier:
NCT01306370
First received: February 28, 2011
Last updated: June 21, 2012
Last verified: February 2011
History of Changes
  Purpose

Objectives:

a) Principal: To assess if the fibrin glue or the tranexamic acid reduce less than 20% the blood losses with respect to the habitual haemostasia in patients with arthroplasty total of knee.

Secondaries: To assess the treatment safety. To perform a cost- analyses.

Methods: Randomized, unicentric, and parallel clinical trial with four comparative groups: Tissucol® (fibrin glue), fibrin glue manufactured by the Cryoseal® system (Banc de Sang i Teixits de Catalunya), tranexamic acid and habitual haemostasia.

Nº of participant centres: 1. Random allocation will be centralised.

Main outcome: Blood losses (ml) in the post-operatory period collected by the habitual drain system.

Secondary outcomes: Proportion of patients with blood transfusion, complications of surgery wound, haemoglobin pre and post-operatoria, units of blood transfused, post-operative mortality, days of hospital stay, safety of interventions assessed.

Size sample calculation: The number needed of patients is 172 (43 per group) to demonstrate a 20% difference in the post-operative blood losses between the treatments assessed and the habitual haemostasia, with a statistical power of 80% and a 0.05 bilateral alpha, and a 20% of withdrawals.

Statistical analysis: The investigators will perform a comparison of outcomes through the "t" test, the Mann-Whitney test of chi square, depending of the evaluated outcomes, quantitative or ordinals or qualitative, respectively. The software used will be SPSS17.


Condition Intervention Phase
Knee Arthropathy
 Drug: Tranexamic Acid
Drug: Fibrin glue
Biological: Fibrin glue
Other: Habitual haemostasis
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prevention of Postoperative Blood Loss: Randomised Unicentric Parallel Clinical Trial That Assess the Efficacy of Fibrin Glue and Tranexamic Acid in Surgical Patients With a Total Knee Arthroplasty.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:

Primary Outcome Measures:
  • Postoperative blood loss (mL) [ Time Frame: During the first 48h after the surgical intervention ] [ Designated as safety issue: No ]
    Blood loss (mL) by the surgical wound collected by drain systems.


Secondary Outcome Measures:
  • Percentage of patients that need a postoperative blood transfusion [ Time Frame: During the first postoperative week ] [ Designated as safety issue: No ]
  • Percentage of patients with surgical wound infection [ Time Frame: During the first postoperative month ] [ Designated as safety issue: Yes ]
  • Percentage of patients with surgical wound dehiscence [ Time Frame: During the first postoperative month ] [ Designated as safety issue: Yes ]
  • Percentage of patients with re-intervention by wound complications [ Time Frame: During the first postoperative month ] [ Designated as safety issue: Yes ]
  • Incidence of deep venous thrombosis [ Time Frame: During the first postoperative week ] [ Designated as safety issue: Yes ]
  • Pain of surgical wound [ Time Frame: During the first postoperative week ] [ Designated as safety issue: Yes ]
  • Units of blood transfusion [ Time Frame: During the first postoperative week ] [ Designated as safety issue: Yes ]
  • hospital length stay [ Time Frame: Days ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: During the first postoperative month ] [ Designated as safety issue: Yes ]

Enrollment: 172
Study Start Date: June 2010
Study Completion Date: November 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tranexamic acid Drug: Tranexamic Acid

Two dosage during the surgical intervention: the first dosage 15-30' before the leg ischemia and the second dosage at 60 -90' after the first dosage.

Each dosage: 2 ampoules of 500mg/5 mL/ampoule

Other Name: Amchafibrin
Experimental: Fibrin glue BSTC
It is homologous fibrin glue from a single blood donor.
 Biological: Fibrin glue
Topical administration, before to close the surgical wound.
Experimental: Tissucol
It is fibrin glue commercialized from multiple donors.
 Drug: Fibrin glue
Topical administration, before to close the surgical wound. Dosage: 2 mL.
Other Name: Tissucol
No Intervention: Habitual haemostasis Other: Habitual haemostasis
The surgical habitual haemostasis.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Total knee arthroplasty
  • The patient consent to participate

Exclusion Criteria:

  • Intolerance drugs to the study or to bovine protein (aprotinin)
  • Antecedent of thromboembolic disease
  • Patient with cardiac alterations of the rhythm
  • Patients with valvular cardiac prosthesis
  • Patients with pro-thrombotic alterations of coagulation
  • Treatment with anticonceptive drugs
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01306370

Locations
Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalunya, Spain, 08025
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Banc de Sang i Teixits
Investigators
Study Director: Martinez Zapata, Mª José Centro Cochrane Iberoamericano. Servicio de Epidemiología Clínica y Salud Pública. IIB Sant Pau
Principal Investigator: Aguilera Roig, Xavier Hospital de la Santa Creu i Sant Pau. IIB Sant Pau
  More Information

No publications provided

Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT01306370     History of Changes
Other Study ID Numbers: 2009-017804-95, TRA-81
Study First Received: February 28, 2011
Last Updated: June 21, 2012
Health Authority: United States: Food and Drug Administration
Spain: Ministry of Health and Consumption

Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
primary knee arthroplasty
fibrin glue
tranexamic acid
topic

Additional relevant MeSH terms:
Joint Diseases
Postoperative Hemorrhage
Musculoskeletal Diseases
Hemorrhage
Pathologic Processes
Postoperative Complications
Fibrin Tissue Adhesive
Hemostatics
 Tranexamic Acid
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013