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C1-inhibitor improves efficacy of red blood cell transfusion in patients suffering from autoimmune hemolytic anemia * an open-labeled pilot trial

C1-inhibitor improves efficacy of red blood cell transfusion in patients suffering from autoimmune hemolytic anemia * an open-labeled pilot trial - C1-Inh in AIHA

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON55361
Enrollment
10
Registered
2012-11-27
Start date
2014-06-04
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

Anemia Autoimmune Hemolytic Anemia

Interventions

Patients will receive C1-inh: 6000 Units before the transfusion and thereafter 3000U, 2000U and 1000U every 12 hours

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Positive (*1+) monospecific antiglobulin test for C3b and/or C3d with/without positivity for IgM OR strongly positive (*3+) monospecific antiglobulin test for C3b and/or C3d with positivity for IgG * Indication for a transfusion with at least 2 red packed cell concentrates based on the clinical assessment by the hematologist in charge * Hemoglobin value at least

Exclusion criteria

Exclusion criteria: * History of arterial and/or venous thromboembolic events in the absence of an actual treatment with Vitamin K-antagonists * Concomitant use of therapeutic doses of heparin * Female patients who are pregnant or breast feeding or adults of reproductive potential who are not using effective birth control methods. If barrier contraceptives are being used, these must be continued throughout the trial by both sexes. Oral contraceptives only are not acceptable. * Patients with known HIV seropositivity or chronic active hepatitis * Patients who have any severe and/or uncontrolled medical condition

Design outcomes

Primary

MeasureTime frame
* improvement of the recovery of RBC transfusion- as defined as a decrease of hemoglobin

Secondary

MeasureTime frame
* Inhibition of the pro-inflammatory response

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)