NCT03801122

Brief Summary

Patients with hematological malignancies are at increased risk of bleeding, especially during intensive chemotherapy. The aim of this study is to compare by thromboelastography changes during the intensive chemotherapy in patients with hematological malignancies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2019

Typical duration for phase_2

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

December 20, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 11, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

March 5, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 11, 2022

Completed
Last Updated

May 6, 2023

Status Verified

May 1, 2023

Enrollment Period

3 years

First QC Date

December 20, 2018

Last Update Submit

May 4, 2023

Conditions

Hematological Malignancies Treated With Intensive Chemotherapy

Keywords

Tranexamic acidbleedinghematological malignanciesthrombocytopenia

Outcome Measures

Primary Outcomes (1)

  • Level of amplitude observed in thromboelastography

    Amplitude levels observed in thromboelastography will be reported

    30 days

Secondary Outcomes (6)

  • Time at the beginning of the clot

    30 minutes

  • Clot formation time

    30 minutes

  • Alpha angle

    30 days

  • Percentage of lysis after 30min

    30 minutes

  • Proportion of patients experiencing bleeding of WHO (World Health Organisation ) grade 2 or above

    30 days

  • +1 more secondary outcomes

Study Arms (3)

Tranexamic acid 3g/day

EXPERIMENTAL

Administration of tranexamic acid 3g/day, with 3 injections/8 hours.

Drug: Tranexamic acid

Tranexamic acid 1.5g/day

EXPERIMENTAL

Administration of tranexamic acid 1.5g/day, with 3 injections/8 hours.

Drug: Tranexamic acid

No treatment

NO INTERVENTION

No treatment (no administration of tranexamic acid)

Interventions

Tranexamic acidDRUG

Administration of tranexamic acid, with 3 injections/8 hours.

Tranexamic acid 1.5g/dayTranexamic acid 3g/day

Eligibility Criteria

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

You may qualify if:

  • Patient affiliated to a social security regimen or beneficiary of the same
  • Signed written informed consent form
  • Confirmed diagnosis of a hematological malignancy and undergoing intensive chemotherapy
  • Expected to experience hypoproliferative thrombocytopenia resulting in a platelet count of ≤10 G/L for ≥ 5 days

You may not qualify if:

  • Pregnant women
  • Patient under guardianship or deprived of his liberty or any condition that may affect the patient's ability to understand and sign the informed consent
  • Refractoriness to platelet transfusion or requirement for a specific type of platelet transfusion (ABO-compatible, plasma-free)
  • Ongoing anticoagulant therapy or antiplatelet therapy at the time of enrolment
  • Treatment with any pro-coagulant agent within 48 hours of enrolment, or enrolment in other trials involving platelet transfusions, platelet growth factors, or presentation of a known hypercoagulable state
  • Diagnosis of arterial or venous thromboembolic disease within the previous year
  • contra-indications to tranexamic acid (allergy, history of seizures, creatinine clearance \< 30 mL/min)
  • Refusing participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

HemorrhageHematologic NeoplasmsThrombocytopenia

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesBlood Platelet DisordersCytopenia

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Emilie Chalayer, MD

    CHU de Saint-Etienne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Arm 1 : Tranexamic acid 3g/day Arm 2 : Tranexamic acid 1.5g/day Arm 3 : No tranexamic acid
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2018

First Posted

January 11, 2019

Study Start

March 5, 2019

Primary Completion

March 9, 2022

Study Completion

July 11, 2022

Last Updated

May 6, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)