NCT02770534

Brief Summary

The primary aim of this study is to investigate the reported enhanced coagulation status (prothrombotic status) in patients with sickle cell disease using 2 laboratory tests; thromboelastography (TEG) and Endogenous Thrombin Potential (ETP), and comparing the results to healthy race matched controls to ascertain if there is a significant difference. Race matching of the control participants is being carried out due to the well reported racial differences in coagulation parameters that exist in healthy individuals. The investigators are aiming to study the clotting state in sickle patients on regular transfusion therapy and those on hydroxycarbamide, both treatments offered to sickle patients to ameliorate the condition. The study will assess the reported prothrombotic state using TEG and ETP.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2016

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 10, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 12, 2016

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

August 1, 2017

Status Verified

July 1, 2017

Enrollment Period

2 months

First QC Date

May 10, 2016

Last Update Submit

July 31, 2017

Conditions

Sickle Cell Disease

Outcome Measures

Primary Outcomes (1)

  • results of TEG and ETP analysis:results confirming enhanced coagulation state in sickle cell patients

    completions of analysis of all subjects and controls.

    4 months

Study Arms (5)

Sickle patients in steady state

Well sickle cell patients attending the outpatient clinic

Procedure: blood test

Sickle cell patients admitted in crisis

Inpatients with acute vaso-occlusive crisis

Procedure: blood test

Sickle patients on transfusion program

Sickle patients managed on a regualar transfusion program

Procedure: blood test

Sickle patients on Hydroxycarbamide

Sickle cell patients managed on hydroxycarbamide and on a stable dose for at least 3 months

Procedure: blood test

Health controls

Well age and race matched individuals without a known diagnosis of sickle cell anaemia

Procedure: blood test

Interventions

blood testPROCEDURE

10mls extra mls of blood taken during usual phlebotomy procedures

Health controlsSickle cell patients admitted in crisisSickle patients in steady stateSickle patients on HydroxycarbamideSickle patients on transfusion program

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult sickle cell patients ( age 16+)attending registered and attending the service at Guys adn St Thomas Hospital.

You may not qualify if:

  • currently pregnant have a known diagnosis of an inherited bleeding disorder such as e.g. von willebrand disease on anticoagulant therapy, have severe liver disease with liver transaminases greater than 5x upper limit of normal.
  • Healthy control paticipants will be race and age matched to the patient cohort and must also not be currently pregnant, have a known diagnosis of an inherited bleeding disorder such as e.g. von willebrand disease. The investigators will also exclude healthy participants on anticoagulant therapy as well as those with severe liver disease and liver transaminases greater than 5x upper limit of normal.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guys and St Thomas NHS Foundation Trust

London, SE1, United Kingdom

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2016

First Posted

May 12, 2016

Study Start

April 1, 2016

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

August 1, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)