Trial to evaluate the effectiveness of a medicine to reduce bleeding in patients with very low platelet counts; platelets being the blood cells that help to reduce bleeding.

Phase 1

• Conditions: Bleeding secondary to thrombocytopaenia associated to haematological malignancies.; MedDRA version: 20.0Level: LLTClassification code 10005103Term: BleedingSystem Organ Class: 100000004866; MedDRA version: 20.1Level: PTClassification code 10066476Term: Haematological malignancySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2014-001513-35-GB
• Lead Sponsor: HS Blood and Transplant.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-02
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 616

Inclusion Criteria

1. At least 18 years of age
2. Confirmed diagnosis of a haematological malignancy
3. Undergoing chemotherapy or haematopoietic stem cell transplantation
4. Anticipated to have a hypoproliferative thrombocytopenia resulting in a platelet count of =10x10 to the power of 9/L for = 5 days
5. Able to comply with treatment and monitoring

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 616
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

1. Diagnosis of acute promyelocytic leukaemia and undergoing induction chemotherapy
2. History of ITP, TTP or HUS
3. Patients receiving L-asparginase as part of their current cycle of treatment
4. Patients with a past history or current diagnosis of arterial or venous thromboembolic disease including myocardial infarction, peripheral vascular disease and retinal arterial or venous thrombosis
5. Patients with a diagnosis/previous history of veno-occlusive disease (also called sinusoidal obstruction syndrome)
6. Patients receiving any pro-coagulant agents (e.g. DDAVP, recombinant Factor VIIa or Prothrombin Complex Concentrates (PCC) within 48 hours of enrolment, or with known hypercoagulable state
7. Known inherited or acquired bleeding disorder. E.g. acquired storage pool deficiency; paraproteinaemia with platelet inhibition; known inherited or acquired prothrombotic disorders
9. Patients receiving anticoagulant therapy or anti-platelet therapy
10. Patients with overt disseminated intravascular coagulation
11. Patints with visible haematuria at time of randomisation
12. Patients requiring a platelet transfusion threshold >10x10 to the power of 9/L at time of randomisation
13. Patients with anuria (defined as urine output < 10mls/hr over 24 hours).
14. Patients who are pregnant
15. Patients enrolled in other trials involving platelet transfusions, anti-fibrinolytics, platelet growth factors or other pro-coagulant agents.
16. Allergic to tranexamic acid or epsilon amino caproic acid
17. Previously randomised in this study at any stage of their treatment

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified