NCT03273998

Brief Summary

Blood coagulation is a complex mechanism that is required for the rapid establishment of a stable fibrin clot. A series of interdependent enzyme-mediated reactions translate the molecular signals that initiate blood coagulation into the formation of the fibrin clot. Congenital coagulopathies result when there is a deficiency of protein co factors and enzymes implicated in blood coagulation

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2018

Shorter than P25 for all trials

Status
unknown

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

August 29, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 6, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

September 12, 2017

Status Verified

September 1, 2017

Enrollment Period

1 year

First QC Date

August 29, 2017

Last Update Submit

September 9, 2017

Conditions

Coagulation Factor Deficiency

Keywords

coagulationbleeding

Outcome Measures

Primary Outcomes (1)

  • prevalence of children with coagulation factors deficiency in Assiut University Children Hospital measured by coagulation factor deficiency checklist

    data collected in sheet measuring type and level of deficient factor and measuring clotting tests(e.g. pt ,aptt)

    1year

Secondary Outcomes (2)

  • evaluation of inheritance of coagulation fa tors deficiency through the checklist measuring other affected family members

    1year

  • evaluation of infectious disease by measuring hepatitis c virus and human immunodeficiency virus

    one year

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

children with coagulation factors deficiency in Assiut University Children Hospital

You may qualify if:

  • All patients with congenital bleeding disorders secondary to coagulation factor deficiency and attending in Assiut University Children Hospital will be included in the study

You may not qualify if:

  • Patients with:
  • Acquired bleeding disorders Thrombasthenia thrombocytopenia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • Mannucci PM, Duga S, Peyvandi F. Recessively inherited coagulation disorders. Blood. 2004 Sep 1;104(5):1243-52. doi: 10.1182/blood-2004-02-0595. Epub 2004 May 11.

    PMID: 15138162RESULT

  • Bolton-Maggs PH. The rare inherited coagulation disorders. Pediatr Blood Cancer. 2013;60 Suppl 1:S37-40. doi: 10.1002/pbc.24336. Epub 2012 Oct 25.

    PMID: 23109366RESULT

  • Peyvandi F, Mannucci PM. Rare coagulation disorders. Thromb Haemost. 1999 Oct;82(4):1207-14.

    PMID: 10544899RESULT

  • Ehrenforth S, Klarmann D, Zabel B, Scharrer I, Kreuz W. Severe factor V deficiency presenting as subdural haematoma in the newborn. Eur J Pediatr. 1998 Dec;157(12):1032. doi: 10.1007/s004310050993. No abstract available.

    PMID: 9877047RESULT

  • Kulkarni R, Soucie JM. Pediatric hemophilia: a review. Semin Thromb Hemost. 2011 Oct;37(7):737-44. doi: 10.1055/s-0031-1297164. Epub 2011 Dec 20.

    PMID: 22187396RESULT

  • von der Lippe C, Frich JC, Harris A, Solbraekke KN. Treatment of hemophilia: A qualitative study of mothers' perspectives. Pediatr Blood Cancer. 2017 Jan;64(1):121-127. doi: 10.1002/pbc.26167. Epub 2016 Jul 29.

    PMID: 27472376RESULT

  • KENDALL AG, LOWENSTEIN L. Alterations in blood coagulation and hemostasis during extracorporeal circulation. II. Can Med Assoc J. 1962 Oct 20;87(16):859-64. No abstract available.

    PMID: 14031889RESULT

MeSH Terms

Conditions

ThrombosisHemorrhage

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • yomna alattar, resident

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Khalid Ibrahim El-Sayeh, Professor

CONTACT

01005484357elsayh23@yahoo.com

Mohamed Amir Othman, Ass prof

CONTACT

01005689353m_amir_riad@aun.edu.eg

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

August 29, 2017

First Posted

September 6, 2017

Study Start

April 1, 2018

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

September 12, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share