NCT01594671

Brief Summary

Total knee arthroplasty is often associated with excessive postoperative bleeding due to increased fibrinolysis. Hence, the objective of the proposed of this multicentre study is to determine the peri-operative bleeding comparing the application of topical and intravenous tranexamic acid with the habitual surgical haemostasis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2012

Shorter than P25 for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 9, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

December 19, 2012

Status Verified

December 1, 2012

Enrollment Period

8 months

First QC Date

May 3, 2012

Last Update Submit

December 18, 2012

Conditions

Blood Loss

Keywords

primary knee arthroplastytranexamic acidtopical

Outcome Measures

Primary Outcomes (1)

  • Total blood loss (mL)

    Blood will be collected by drainages during the first 24 hours after surgery.

    at 24 hours postoperatively

Secondary Outcomes (3)

  • Hidden blood loss

    From admission to hospital until an average of 5 days postoperative period

  • Wound complications

    5 weeks postoperatively

  • Adverse effect related with the interventions

    5 weeks postoperatively

Study Arms (3)

Tranexamic acid

EXPERIMENTAL

Intravenous Tranexamic Acid Two dosage Tranexamic acid 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

Drug: Tranexamic AcidOther: haemostasia

Habitual haemostasia

ACTIVE COMPARATOR

The surgical habitual haemostasia.

Other: haemostasia

Topical Tranexamic acid

EXPERIMENTAL

Topical Tranexamic acid one dose before the closure of the knee joint: a solution containing 1g of tranexamic acid in 50 ml of normal saline (0.9% sodium chloride) applied with a syringe diffuser.

Drug: Tranexamic AcidOther: haemostasia

Interventions

Tranexamic AcidDRUG

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

Also known as: Amchafibrin
Tranexamic acid
haemostasiaOTHER

The surgical habitual haemostasia: electrocoagulation of the bleeding tissues

Habitual haemostasiaTopical Tranexamic acidTranexamic acid

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Unilateral Total knee arthroplasty
  • The patient consent to participate

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital de la Esperanza

Barcelona, Barcelona, 08024, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08025, Spain

Location

MeSH Terms

Conditions

Hemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Aguilera X, M.D

    Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    PRINCIPAL INVESTIGATOR

  • Martinez-Zapata MJ, PhD

    Centro Cochrane Iberoamericano. IIB Sant Pau

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2012

First Posted

May 9, 2012

Study Start

February 1, 2012

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

December 19, 2012

Record last verified: 2012-12

Locations

ES(2)