NCT02403596

Brief Summary

This study evaluates the efficacy of tranexamic acid versus placebo on perioperative blood loss using two dosage regimens (standard and extended) after a surgery during total hip arthroplasty in patients receiving the novel fast-acting oral anticoagulant rivaroxaban for prophylaxis of thrombosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
231

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

4 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2015

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 31, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

October 20, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2017

Completed
Last Updated

January 9, 2018

Status Verified

January 1, 2018

Enrollment Period

1.9 years

First QC Date

March 13, 2015

Last Update Submit

January 8, 2018

Conditions

Blood Loss After a Total Hip Replacement

Keywords

Hip replacementrivaroxabanexacylblood loss

Outcome Measures

Primary Outcomes (1)

  • Total blood loss

    Total Blood Loss (TBL) in mL of red blood cells, calculated using Mercuriali's formula at 100% haematocrit (Ht) and then converted to mL of blood at 35% Ht

    Between Day-1of surgery and Day+3 of surgery (5 days)

Secondary Outcomes (8)

  • Difference in haemoglobin level (g/dL) between Day-1 and Day+3

    5 days

  • Maximum difference in haemoglobin level (g/dL) from D-1 up to D+3

    5 days

  • Number of transfusions and volume in mL performed during hospitalisation (operating theatre and unit)

    5 days

  • Major haemorrhagic events, clinically significant non-major haemorrhagic events and minor haemorrhagic events

    3 month

  • Surgical revision

    3 month

  • +3 more secondary outcomes

Study Arms (3)

Group 1: Exacyl®: Standard treatment

EXPERIMENTAL

Intravenous use. 1g Exacyl® at H0 (Hour = 0 in other term at the time of incision) then 1g Exacyl® at H+3 then 1g Exacyl® placebo at H+7 and H+11

Drug: Exacyl®Other: Placebo of Exacyl®

Group 2: Exacyl®: Extended treatment

EXPERIMENTAL

Intravenous use. 1g Exacyl® at H0 (Hour = 0 in other term at the time of incision) then 1g Exacyl® at H+3 / H+7 and H+11

Drug: Exacyl®

Group 3: Placebo

PLACEBO COMPARATOR

This group will receive a placebo of Exacyl®: 1g placebo of Exacyl® at H0 (Hour = 0 in other term at the time of incision) then 1g placebo of Exacyl® at H+3 / H+7 and H+11

Other: Placebo of Exacyl®

Interventions

Exacyl®DRUG
Also known as: Tranexamic acid
Group 1: Exacyl®: Standard treatmentGroup 2: Exacyl®: Extended treatment
Placebo of Exacyl®OTHER
Group 1: Exacyl®: Standard treatmentGroup 3: Placebo

Eligibility Criteria

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

You may qualify if:

  • Over 18 years of age
  • Scheduled to undergo elective non-traumatic primary cementless THA
  • Having given written informed consent to participate in the trial
  • Covered by Social Security

You may not qualify if:

  • Rapidly destructive arthrosis of the hip
  • History of prior surgery on the operative hip
  • Contraindications to the use of tranexamic acid:
  • Ischaemic artery disease (angina pectoris, myocardial infarction, acute coronary syndrome or stroke)
  • History of venous thromboembolism
  • Severe renal impairment, i.e. with clearance \< 30mL/mn
  • Epilepsy or history of convulsions
  • Contraindications to the use of rivaroxaban
  • Severe renal failure (clearance \<30ml / min)
  • Cirrhotic patients with Child Pugh B
  • Pregnancy and breastfeeding
  • Cognitive disorder that precludes giving informed consent
  • Refusal to participate in trial
  • Allergy to either of the trial treatments
  • On-going prophylaxis of thrombosis using an agent other than rivaroxaban
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

HIA Clermont Tonnerre Brest

Brest, 29200, France

Location

Polyclinique de Keraudren

Brest, 29287, France

Location

CHRU Brest

Brest, 29609, France

Location

CH Morlaix

Morlaix, 29672, France

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 Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2015

First Posted

March 31, 2015

Study Start

October 20, 2015

Primary Completion

August 29, 2017

Study Completion

August 29, 2017

Last Updated

January 9, 2018

Record last verified: 2018-01

Locations

FR(4)