A Trial of Antenatal Treatment of Alloimmune Thrombocytopenia

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

IVIG (Intravenous Immunoglobulin)

prednisone

About this trial

This is an interventional treatment trial for Alloimmune Thrombocytopenia focused on measuring Alloimmune thrombocytopenia, Fetal alloimmune thrombocytopenia

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Pregnant women are eligible for inclusion into the Very High Risk Group if they: are PLA-1 (platelet antigen A1) 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

Sites / Locations

New York Presbyterian Hospital-Weill Cornell Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

IVIG x 2

IVIG x 1 + prednisone

Arm Description

IVIG 2 g/kg/wk divided into 2 infusions per week for women with a fetus affected by FNAIT

IVIG 1 g/kg/wk in 1 infusion per week + prednisone 0.5 mg po daily for women with a fetus affected by FNAIT

Outcomes

Primary Outcome Measures

Number of Newborns With a Birth Platelet Count > 50,000/uL

this uses the birth platelet count of the fetuses from the study when they are born

Secondary Outcome Measures

Intracranial Hemorrhage: Number Occurring in Fetuses and Newborns of Mothers in Study

number of ICH assessed by fetal and neonatal ultrasound with MRI back up most commonly in utero so range from 20-40 weeks fo gestation

Number of Fetal Platelet Counts > 50,000/uL

Number of Fetal Platelet Counts > 50,000/uL Among Those Who Underwent Fetal Blood Sampling and Had a Fetal Platelet Count Determined

Full Information

NCT ID

NCT00194987

First Posted

September 13, 2005

Last Updated

October 9, 2018

Sponsor

Weill Medical College of Cornell University

Collaborators

New York Presbyterian Hospital, Columbia University

1. Study Identification

Unique Protocol Identification Number

NCT00194987

Brief Title

A Trial of Antenatal Treatment of Alloimmune Thrombocytopenia

Official Title

A Randomized Multicenter Trial of Antenatal Treatment of Alloimmune Thrombocytopenia

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

April 2001 (undefined)

Primary Completion Date

June 30, 2015 (Actual)

Study Completion Date

June 30, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Weill Medical College of Cornell University

Collaborators

New York Presbyterian Hospital, Columbia University

4. Oversight

Data Monitoring Committee

No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alloimmune Thrombocytopenia, Fetal Alloimmune Thrombocytopenia

Keywords

Alloimmune thrombocytopenia, Fetal alloimmune thrombocytopenia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Model Description

randomization between 2 groups

Masking

None (Open Label)

Masking Description

participants and their physicians will know if they are receiving IVIG x 2 or IVIG x1 plus prednisone

Allocation

Randomized

Enrollment

102 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IVIG x 2

Arm Type

Experimental

Arm Description

IVIG 2 g/kg/wk divided into 2 infusions per week for women with a fetus affected by FNAIT

Arm Title

IVIG x 1 + prednisone

Arm Type

Experimental

Arm Description

IVIG 1 g/kg/wk in 1 infusion per week + prednisone 0.5 mg po daily for women with a fetus affected by FNAIT

Intervention Type

Drug

Intervention Name(s)

IVIG (Intravenous Immunoglobulin)

Intervention Description

one gram per kg of IVIG per infusion given either once or twice

Intervention Type

Drug

Intervention Name(s)

prednisone

Intervention Description

in arm with IVIG 1 gm/kg/wk will also receive prednisone 0.5 mg/kg/day

Primary Outcome Measure Information:

Title

Number of Newborns With a Birth Platelet Count > 50,000/uL

Description

this uses the birth platelet count of the fetuses from the study when they are born

Time Frame

32-40 weeks (the endpoint is the birth which is not at the same number of weeks for all of the babies. This is why the weeks are not listed specifically eg week 40

Secondary Outcome Measure Information:

Title

Intracranial Hemorrhage: Number Occurring in Fetuses and Newborns of Mothers in Study

Description

number of ICH assessed by fetal and neonatal ultrasound with MRI back up most commonly in utero so range from 20-40 weeks fo gestation

Time Frame

time of ICH (range 20-40 wks)

Title

Number of Fetal Platelet Counts > 50,000/uL

Description

Number of Fetal Platelet Counts > 50,000/uL Among Those Who Underwent Fetal Blood Sampling and Had a Fetal Platelet Count Determined

Time Frame

32 +/- 2 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Pregnant women are eligible for inclusion into the Very High Risk Group if they: are PLA-1 (platelet antigen A1) 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James B Bussel, M.D.

Organizational Affiliation

Weill Medical College of Cornell University

Official's Role

Principal Investigator

Facility Information:

Facility Name

New York Presbyterian Hospital-Weill Cornell Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

27611703

Citation

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.

Results Reference

derived

PubMed Identifier

17666597

Citation

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. doi: 10.1097/01.AOG.0000270302.80336.dd.

Results Reference

derived

Alloimmune Thrombocytopenia, Fetal Alloimmune Thrombocytopenia

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial