A Trial of Antenatal Treatment of Alloimmune Thrombocytopenia

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 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: June 13, 2013
Last verified: June 2013
  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: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Multicenter Trial of Antenatal Treatment of Alloimmune Thrombocytopenia

Resource links provided by NLM:


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 Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (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
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
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: 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 Medical College of Cornell University
  More Information

No publications provided by Weill Medical College of Cornell University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: June 13, 2013
Health Authority: United States: Food and Drug Administration

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
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014