NCT00279578

Brief Summary

In the present study we are examining the clot formation and clot stability in patients with severe haemophilia A after they receive recombinat factor VIII and after addition of tranexamic acid. Our hypothesis is that addition of tranexamic increases the clot stability. The perpective of the study is to document whether it is relevant to use traneksamic acid in surgery in patients with severe haemophilia A.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2006

Shorter than P25 for not_applicable

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

January 1, 2006

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 17, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 19, 2006

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

November 16, 2006

Status Verified

November 1, 2006

First QC Date

January 17, 2006

Last Update Submit

November 15, 2006

Conditions

Hemophilia A

Keywords

haemophilia Athrombelastographyrecombinant factor VIIIthrombin generation

Outcome Measures

Primary Outcomes (1)

  • Clot stability

Secondary Outcomes (1)

  • clot formation,thrombine generation

Interventions

ReFacto (Recombinant factor VIII) and Tranexamic acidDRUG

Eligibility Criteria

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

You may qualify if:

  • Severe haemophilia A
  • Above 17 years old
  • Thrombocyt count above 100 x 109/l within the past two years

You may not qualify if:

  • Received recombinant factor VIII with in the past 3 days
  • Inhibitor against recombinant factor VIII
  • HIV-positive
  • Ongoing treatment for hepatitis C
  • Known kidney disease
  • Allergy against Tranexamic acid
  • Not able to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Biochemistry, Center for Haemophilia and Thrombosis

Aarhus, 8200, Denmark

Location

MeSH Terms

Conditions

Hemophilia A

Interventions

recombinant factor VIII SQFactor VIIITranexamic Acid

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Blood Coagulation FactorsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsProtein PrecursorsBiological FactorsCyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Anne-Mette Hvas, MD, Ph.D.

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 17, 2006

First Posted

January 19, 2006

Study Start

January 1, 2006

Study Completion

June 1, 2006

Last Updated

November 16, 2006

Record last verified: 2006-11

Locations

DK(1)