A Trial of Antenatal Treatment of Alloimmune Thrombocytopenia

This study is currently recruiting participants.

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Contacts and Locations

Verified January 2017 by Weill Medical College of Cornell University

Sponsor:

Collaborators:

New York Presbyterian Hospital

Columbia University

Information provided by (Responsible Party):

Weill Medical College of Cornell University

ClinicalTrials.gov Identifier:

NCT00194987

First received: September 13, 2005

Last updated: January 30, 2017

Last verified: January 2017

History of Changes

Purpose

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	Intervention	Phase
Alloimmune Thrombocytopenia Fetal Alloimmune Thrombocytopenia	Drug: IVIG (Intravenous Immunoglobulin)	Phase 2 Phase 3


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: No masking Primary Purpose: Treatment
Official Title:	A Randomized Multicenter Trial of Antenatal Treatment of Alloimmune Thrombocytopenia

Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:

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


Estimated Enrollment:	120
Study Start Date:	April 2001
Estimated Study Completion Date:	June 30, 2017
Estimated Primary Completion Date:	June 30, 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 3	Drug: IVIG (Intravenous Immunoglobulin) one to two mg per kg once-twice weekly

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00194987

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

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
Study First Received:	September 13, 2005
Last Updated:	January 30, 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

ClinicalTrials.gov processed this record on July 24, 2017

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