A Trial of Antenatal Treatment of Alloimmune Thrombocytopenia

This study is currently recruiting participants.

Verified by Weill Medical College of Cornell University, May 2008

Sponsors and Collaborators:	Weill Medical College of Cornell University New York Presbyterian Hospital Columbia University
Information provided by:	Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:	NCT00194987

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 II Phase III

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment
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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	120
Study Start Date:	April 2001
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

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

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders 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

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

Contacts

Contact: Megan Wissert, R.N.C.

212-746-3416

mwissert@nyp.org

Locations

United States, New York
New York Presbyterian Hospital-Weill Cornell Medical Center	Recruiting
New York, New York, United States, 10021
Contact: Megan Wissert, R.N.C. 212-746-3416 mwissert@nyp.org
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 Cornell Medical College

More Information

Publications indexed to this study:

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 Cornell ( James Bussel )
Study ID Numbers:	0102004801
Study First Received:	September 13, 2005
Last Updated:	May 20, 2008
ClinicalTrials.gov Identifier:	NCT00194987
Health Authority:	United States: Food and Drug Administration

Keywords provided by Weill Medical College of Cornell University:

Alloimmune thrombocytopenia
Fetal alloimmune thrombocytopenia

Study placed in the following topic categories:

Thrombocytopathy
Antibodies
Thrombocytopenia
Immunoglobulins, Intravenous

Hematologic Diseases
Blood Platelet Disorders
Rho(D) Immune Globulin
Immunoglobulins

Additional relevant MeSH terms:

Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009