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The effect of coagulation factors on the reduction of joint/ non-joint bleeding and the consumption of coagulation factor in patients with severe A hemophilia

The efficacy of prophylactic treatment with coagulation factores in reducing the frequency of joint/non-joint bleedingand the consumption of coagulation factor in under 15 year old patients with severe A hemophilia

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT20170211032495N1
Enrollment
15
Registered
2018-01-17
Start date
2018-01-04
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemophilia. Hereditary factor VIII deficiency

Interventions

Intervention 1: First intervention group: Patients with at least one bleeding in soft or articular tissue that have not received coagulation factor: Start dose: 25 units per kg factor VIII once a week
Prevention
First intervention group: Patients with at least one bleeding in soft or articular tissue that have not received coagulation factor: Start dose: 25 units per kg factor VIII once a week, first stage of
Second intervention group: Patients who have surely received more than 50 days of coagulation factor: Start dose: 25 units per kg factor VIII once a week, first stage of positive change: 25 units per
Third intervention group: Patients who have, or have probably, received less than 50 days of coagulation factor: Start dose: 50 units per kg factor VIII once a week, first stage of positive change: 30
Control group: Patients without bleeding in soft/articular tissue): No action

Sponsors

Vice chancellor for research of Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Months to 15 Years

Inclusion criteria

Inclusion criteria: Negative antibody Factor VIII less than 1%

Exclusion criteria

Exclusion criteria: Age over 15 years Presence of an inhibitor

Design outcomes

Primary

MeasureTime frame
Joint/ non-joint Bleeds. Timepoint: Before the intervention and 6 months after the intervention. Method of measurement: Factor VIII test.;Consumption of coagulation factor. Timepoint: Before the intervention and 6 months after the intervention. Method of measurement: Counting the number of used vials.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Katayoon Karimi

Imam Khomeini Hospital Complex

dr_k_karimi_52071@yahoo.com+98 21 6691 1293

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026