A Trial of Antenatal Treatment of Alloimmune Thrombocytopenia

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

The purposes of this study are to provide medical management by giving treatment to the mother that will bring up the fetal platelet count and to minimize the number of invasive procedures to the fetus (which may result in serious fetal injuries).

Condition or disease	Intervention/treatment	Phase
Alloimmune Thrombocytopenia; Fetal Alloimmune Thrombocytopenia	Drug: IVIG (Intravenous Immunoglobulin)	Phase 2; Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	120 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Randomized Multicenter Trial of Antenatal Treatment of Alloimmune Thrombocytopenia
Study Start Date :	April 2001
Estimated Primary Completion Date :	June 30, 2017
Estimated Study Completion Date :	June 30, 2017

Arms and Interventions

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Arm	Intervention/treatment
Experimental: 3	Drug: IVIG (Intravenous Immunoglobulin); one to two mg per kg once-twice weekly

Outcome Measures

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Primary Outcome Measures :

1. To raise the platelet count of affected fetus. [ Time Frame: 20-30 weeks ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 50 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Pregnant women are eligible for inclusion into the Very High Risk Group if they:

• are PLA-1 negative and have known platelet incompatibility with their fetus
• have had a previous child who suffered an antenatal hemorrhage prior to 28 weeks gestation (as best as could be estimated)
• are less than 19 weeks gestation

Pregnant women are eligible for inclusion into the High Risk Group if they:

• are PLA-1 negative and have known platelet incompatibility with the fetus
• have had a previous child who suffered an antenatal hemorrhage after 28 weeks gestation (as best as could be estimated)
• are between 12-30 weeks gestation

Pregnant women are eligible for inclusion into the Standard Risk Group if they:

• are PLA-1 negative and have known platelet incompatibility with the fetus
• have not had a previous child who suffered an antenatal hemorrhage
• are between 20-30 weeks gestation

Exclusion Criteria:

Women are not eligible for inclusion into the Very High Risk Group if they:

• have had a previous child who suffered an antenatal hemorrhage after 28 weeks gestation
• are greater than 19 weeks gestation

Women are not eligible for inclusion into the High Risk Group if they:

• have had a previous child who suffered an antenatal hemorrhage prior to 28 weeks gestation
• are greater than 30 weeks gestation

Women are not eligible for inclusion into the Standard Risk Group if they:

• have had a previous child who suffered an antenatal hemorrhage
• are greater than 30 weeks gestation

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: James B. Bussel, M.D.	212-746-3474	jbussel@med.cornell.edu
Contact: Arelys M Rocha, BS, BA, CCRC	212-746-3423	arr7008@med.cornell.edu

Locations

United States, New York
New York Presbyterian Hospital-Weill Cornell Medical Center	Recruiting
New York, New York, United States, 10021
Contact: James B. Bussel, M.D. 212-746-3474 jbussel@med.cornell.edu
Principal Investigator: James B Bussel, M.D.

Sponsors and Collaborators

Weill Medical College of Cornell University

New York Presbyterian Hospital

Columbia University

Investigators

Principal Investigator:	James B Bussel, M.D.	Weill Medical College of Cornell University

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lakkaraja M, Jin JC, Manotas KC, Vinograd CA, Ferd P, Gabor J, Wissert M, Berkowitz RL, McFarland JG, Bussel JB. Blood group A mothers are more likely to develop anemia during antenatal intravenous immunoglobulin treatment of fetal and neonatal alloimmune thrombocytopenia. Transfusion. 2016 Oct;56(10):2449-2454. doi: 10.1111/trf.13779. Epub 2016 Sep 9.

Berkowitz RL, Lesser ML, McFarland JG, Wissert M, Primiani A, Hung C, Bussel JB. Antepartum treatment without early cordocentesis for standard-risk alloimmune thrombocytopenia: a randomized controlled trial. Obstet Gynecol. 2007 Aug;110(2 Pt 1):249-55.

Responsible Party:	Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:	NCT00194987 History of Changes
Other Study ID Numbers:	0102004801
First Posted:	September 19, 2005
Last Update Posted:	February 1, 2017
Last Verified:	January 2017

Keywords provided by Weill Medical College of Cornell University:

Alloimmune thrombocytopenia; Fetal alloimmune thrombocytopenia

Additional relevant MeSH terms:

Thrombocytopenia; Blood Platelet Disorders; Hematologic Diseases; Immunoglobulins; Antibodies	Immunoglobulins, Intravenous; gamma-Globulins; Rho(D) Immune Globulin; Immunologic Factors; Physiological Effects of Drugs