NCT01817257

Brief Summary

This is a two year, multicentre, mixed methods feasibility study including a randomised controlled two-arm interventional trial, a nested qualitative study, focus groups and a United Kingdom (UK) wide survey exercise.

Trial Health

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Monitor

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for phase_2 cancer

Timeline
Completed

Started Dec 2013

Shorter than P25 for phase_2 cancer

Geographic Reach
1 country

5 active sites

Status
terminated

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

March 8, 2013

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 25, 2013

Completed
8 months until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

October 29, 2018

Status Verified

October 1, 2018

Enrollment Period

1.2 years

First QC Date

March 8, 2013

Last Update Submit

October 25, 2018

Conditions

CancerThrombosisVenous ThromboembolismDeep Vein ThrombosisPulmonary Embolus

Keywords

CancerThrombosisVenous thromboembolismDeep vein thrombosisPulmonary embolus

Outcome Measures

Primary Outcomes (1)

  • Number of eligible and recruited patients (target recruitment rate of 30% of eligible patients) over 12 months, and proportion of participants with recurrent VTEs during follow-up.

    24 months

Secondary Outcomes (4)

  • Completion of trial protocol

    24 months

  • Quality of life

    24 months

  • Symptom assessment during the study

    24 months

  • Attitudes of clinicians and patients to extended treatment with LMWH

    24 months

Study Arms (2)

A: Continue treatment

EXPERIMENTAL

Continue low molecular weight heparin (LMWH) at treatment dose according to body weight for further six months.

Drug: Low Molecular Weight Heparin (LMWH)

B: Discontinue treatment

NO INTERVENTION

Discontinue low molecular weight heparin (LMWH) once patient has received six months treatment following index VTE case.

Interventions

Low Molecular Weight Heparin (LMWH)DRUG

Participants randomised to Arm A will have already received LMWH (Fragmin®), tinzaparin (Innohep®) or enoxaparin (Clexane®) at treatment dose for six months off trial, and should continue the same drug at the same dose for a further six months on trial. No dose alterations are required unless clinically indicated.

Also known as: Dalteparin (Fragmin®), Tinzaparin (Innohep®), Enoxaparin (Clexane®)
A: Continue treatment

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Receiving LMWH for treatment of CAT for five months
  • Locally advanced or metastatic cancer
  • Able to self-administer LMWH, or have LMWH administered by a carer
  • Able to give informed consent
  • Age ≥16 years

You may not qualify if:

  • Receiving drug other than LMWH for CAT
  • Contraindication to anticoagulation
  • Fitted with a prosthetic heart valve
  • Pregnant and/or lactating females

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

George Eliot Hospital NHS Trust (George Eliot Hospital)

Nuneaton, Warwickshire, United Kingdom

Location

Worcestershire Acute Hospitals NHS Trust (Worcester Royal Hospital)

Worcester, Worcestershire, United Kingdom

Location

Velindre NHS Trust (Velindre Cancer Centre)

Cardiff, United Kingdom

Location

Aneurin Bevan Health Board (Royal Gwent Hospital)

Newport, United Kingdom

Location

South Warwickshire NHS Foundation Trust (Warwick Hospital)

Warwick, United Kingdom

Location

Related Publications (1)

  • Noble SI, Nelson A, Fitzmaurice D, Bekkers MJ, Baillie J, Sivell S, Canham J, Smith JD, Casbard A, Cohen A, Cohen D, Evans J, Fletcher K, Johnson M, Maraveyas A, Prout H, Hood K. A feasibility study to inform the design of a randomised controlled trial to identify the most clinically effective and cost-effective length of Anticoagulation with Low-molecular-weight heparin In the treatment of Cancer-Associated Thrombosis (ALICAT). Health Technol Assess. 2015 Oct;19(83):vii-xxiii, 1-93. doi: 10.3310/hta19830.

    PMID: 26490434RESULT

MeSH Terms

Conditions

NeoplasmsThrombosisVenous ThromboembolismVenous ThrombosisPulmonary Embolism

Interventions

Heparin, Low-Molecular-WeightDalteparinTinzaparinEnoxaparin

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular DiseasesThromboembolismLung DiseasesRespiratory Tract DiseasesEmbolism

Intervention Hierarchy (Ancestors)

HeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Simon Noble, Dr

    Cardiff University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Trial Manager

Study Record Dates

First Submitted

March 8, 2013

First Posted

March 25, 2013

Study Start

December 1, 2013

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

October 29, 2018

Record last verified: 2018-10

Locations

GB(5)