Acute HIT II (Heparin-induced Thrombocytopenia Type II)NCT01304238

Retrospective Registry of Patients With Acute Heparin-induced Thrombocytopenia Type II

An observational study of Acute HIT II (Heparin-induced Thrombocytopenia Type II), run by GlaxoSmithKline.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this retrospective registry is to collect data about patients with acute HIT II (Heparin-induced Thrombocytopenia type II) which were treated with Lepirudin, Danaparoid, Argatroban or Fondaparinux. It is a main objective of this registry to mirror the daily routine in this indication in Germany. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute HIT II (Heparin-induced Thrombocytopenia Type II)
What is being tested?: lepirudin, danaparoid and argatroban
How many people: 195 participants
Where: No sites listed yet
Study dates: Feb 2009to Jan 2010
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Hospitalized patients with HIT

Who may be able to join

Acute HIT II (Heparin-induced Thrombocytopenia type II), 4T-Score
Treatment of HIT with Lepirudin, Danaparoid, Argatroban or Fondaparinux

Who cannot join

About this study

Official title: Systematische Dokumentation Von Patienten Mit Akutem HIT-Verdacht

Conditions: Acute HIT II (Heparin-induced Thrombocytopenia Type II)
Being tested: lepirudin, danaparoid, argatroban, fondaparinux
Keywords: Retrospective evaluation of patients with acute Heparin-induced Thrombocytopenia type II treated with Fondaparinux

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

lepirudinDrug
lepirudin
danaparoidDrug
danaparoid
argatrobanDrug
argatroban
fondaparinuxDrug
fondaparinux

Study groups in NCT01304238
Study group	Role	What they receive
lepirudin		lepirudin treated subjects Receives: Drug: lepirudin
danaparoid		danaparoid treated subjects Receives: Drug: danaparoid
argatroban		argatroban treated subjects Receives: Drug: argatroban
fondaparinux		fondaparinux treated subjects Receives: Drug: fondaparinux

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II
Thrombosis is a clotting in a blood vessel. Pulmonary embolism is a clot, usually from the deep veins of the legs, carried away with the venous bloodstream into the lungs, where it may block pulmonary vessels. Participants' medical records were used to abstract data that were collected on standardized hard copy Case Report Forms (CRFs).
Measured: 19 January 2005 to 25 October 2009

Secondary outcomes (5)

Number of Participants Diagnosed With Bleeding After the Occurrence of HIT II
Participants' medical records were used to abstract data that were collected on standardized hard copy Case Report Forms (CRFs). Bleeding was documented in the participant files.
Measured: 19 January 2005 to 25 October 2009
Number of Participants With Fatal Complications After the Occurrence of HIT II
Participants' medical records were used to abstract data that were collected on standardized hard copy Case Report Forms (CRFs). A fatal complication is defined as a complication resulting in death.
Measured: 19 January 2005 to 25 October 2009
Number of Participants Who Underwent Amputation After the Occurrence of HIT II
Participants' medical records were used to abstract data that were collected on standardized hard copy Case Report Forms (CRFs).
Measured: 19 January 2005 to 25 October 2009
Number of Participants Who Were Diagnosed With Thrombocytopenia (Recurrent of Persistent) After the Occurrence of HIT II
Participants' medical records were used to abstract data that were collected on standardized hard copy Case Report Forms (CRFs). Thrombocytopenia after HIT-II was documented in the participant files.
Measured: 19 January 2005 to 25 October 2009
Number of Participants Who Experienced Skin Changes (Erythema and Necrosis) After the Occurrence of HIT II
Participants' medical records were used to abstract data that were collected on standardized hard copy Case Report Forms (CRFs). Erythema is a redness of the skin caused by hyperemia. Necrosis is the premature death of cells or tissues.
Measured: 19 January 2005 to 25 October 2009

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2009Jan 2010

First posted25 Feb 2011 (estimated)
Study startFeb 2009
Primary completionJan 2010
Study completionJan 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Acute HIT II (Heparin-induced Thrombocytopenia Type II)Studies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 195 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01304238
Sponsor's protocol ID: 108745
Status last verified: Jun 2017
First submitted: 27 Jan 2011
Last updated: 6 Jul 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Schindewolf M, Steindl J, Beyer-Westendorf J, Schellong S, Dohmen PM, Brachmann J, Madlener K, Potzsch B, Klamroth R, Hankowitz J, Banik N, Eberle S, Muller MM, Kropff S, Lindhoff-Last E. Use of Fondaparinux Off-Label or Approved Anticoagulants for Management of Heparin-Induced Thrombocytopenia. J Am Coll Cardiol. 2017 Nov 28;70(21):2636-2648. doi: 10.1016/j.jacc.2017.09.1099.
PubMed 29169470

Study at a glance

From the registry record, last updated by the sponsor on 6 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Systematische Dokumentation Von Patienten Mit Akutem HIT-Verdacht
ClinicalTrials.gov ID: NCT01304238
Acronym / sponsor ID: 108745
Conditions: Acute HIT II (Heparin-induced Thrombocytopenia Type II)
Keywords: Retrospective evaluation of patients with acute Heparin-induced Thrombocytopenia type II treated with Fondaparinux
Study type: Observational
Recruitment status: Completed
Enrolment: 195 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Feb 2009
Primary completion: Jan 2010 (actual)
Study completion: Jan 2010 (actual)
First posted: 25 Feb 2011 (estimated)
Results: Posted 25 Feb 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 4

Arm	Type	Receives
lepirudin	–	Drug: lepirudinlepirudin treated subjects
danaparoid	–	Drug: danaparoiddanaparoid treated subjects
argatroban	–	Drug: argatrobanargatroban treated subjects
fondaparinux	–	Drug: fondaparinuxfondaparinux treated subjects

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Hospitalized patients with HIT

Key inclusion criteria (2 listed)

Acute HIT II (Heparin-induced Thrombocytopenia type II), 4T-Score
Treatment of HIT with Lepirudin, Danaparoid, Argatroban or Fondaparinux

Key exclusion criteria (1 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
lepirudinlepirudin	Drug	lepirudin
danaparoiddanaparoid	Drug	danaparoid
argatrobanargatroban	Drug	argatroban
fondaparinuxfondaparinux	Drug	fondaparinux

Primary outcome

Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II
Time frame: 19 January 2005 to 25 October 2009
Thrombosis is a clotting in a blood vessel. Pulmonary embolism is a clot, usually from the deep veins of the legs, carried away with the venous bloodstream into the lungs, where it may block pulmonary vessels. Participants' medical records were used to abstract data that were collected on standardized hard copy Case Report Forms (CRFs).

5 secondary outcomes

Number of Participants Diagnosed With Bleeding After the Occurrence of HIT II
Time frame: 19 January 2005 to 25 October 2009
Number of Participants With Fatal Complications After the Occurrence of HIT II
Time frame: 19 January 2005 to 25 October 2009
Number of Participants Who Underwent Amputation After the Occurrence of HIT II
Time frame: 19 January 2005 to 25 October 2009
Number of Participants Who Were Diagnosed With Thrombocytopenia (Recurrent of Persistent) After the Occurrence of HIT II
Time frame: 19 January 2005 to 25 October 2009
Number of Participants Who Experienced Skin Changes (Erythema and Necrosis) After the Occurrence of HIT II
Time frame: 19 January 2005 to 25 October 2009

Results and safety

Results posted to the registry on 25 Feb 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Argatroban	32	32
Lepirudin	4	4
Danaparoid	46	46
Fondaparinux	78	78
Argatroban/Fondaparinux	11	11
Danaparoid/Argatroban	11	11
Danaparoid/Fondaparinux	5	5
Danaparoid/Lepirudin	4	4
Danaparoid/Fondaparinux/Lepirudin	1	1
Argatroban/Danaparoid/Fondaparinux	3	3

Primary outcome: Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II

Time frame: 19 January 2005 to 25 October 2009. Number. Unit: participants

Measure	Argatroban n = 32	Lepirudin n = 4	Danaparoid n = 46	Fondaparinux n = 78	Argatroban/Fondaparinux n = 11	Danaparoid/Argatroban n = 11	Danaparoid/Fondaparinux n = 5	Danaparoid/Lepirudin n = 4	Danaparoid/Fondaparinux/Lepirudin n = 1	Argatroban/Danaparoid/Fondaparinux n = 3
Thrombosis	31	4	45	78	11	6	5	1	1	3
No thrombosis or pulmonary embolism	1	0	1	0	0	4	0	2	0	0
Pulmonary embolism	0	0	0	0	0	1	0	1	0	0
Thrombosis and pulmonary embolism	0	0	0	0	0	0	0	0	0	0
Unknown	0	0	0	0	0	0	0	0	0	0

Population analysed: All documented participants diagnosed with suspected acute HIT II and a 4T Score of ≥4 who had received at least one dose of argatroban, lepirudin, danaparoid, or fondaparinux. The 4T score (range: 0-8) was developed to predict the probability of HIT.

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Argatroban	0 of 0	0 of 0	Not reported
Lepirudin	0 of 0	0 of 0	Not reported
Danaparoid	0 of 0	0 of 0	Not reported
Fondaparinux	0 of 0	0 of 0	Not reported
Argatroban/Fondaparinux	0 of 0	0 of 0	Not reported
Danaparoid/Argatroban	0 of 0	0 of 0	Not reported
Danaparoid/Fondaparinux	0 of 0	0 of 0	Not reported
Danaparoid/Lepirudin	0 of 0	0 of 0	Not reported
Danaparoid/Fondaparinux/Lepirudin	0 of 0	0 of 0	Not reported
Argatroban/Danaparoid/Fondaparinux	0 of 0	0 of 0	Not reported

Limitations and caveats (from the sponsor): Due to the retrospective nature of the data collection in this study, it is impossible to be precise about dose and frequency of dosing.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29169470Schindewolf M, Steindl J, Beyer-Westendorf J, Schellong S, Dohmen PM, Brachmann J, Madlener K, Potzsch B, Klamroth R, Hankowitz J, Banik N, Eberle S, Muller MM, Kropff S, Lindhoff-Last E. Use of Fondaparinux Off-Label or Approved Anticoagulants for Management of Heparin-Induced Thrombocytopenia. J Am Coll Cardiol. 2017 Nov 28;70(21):2636-2648. doi: 10.1016/j.jacc.2017.09.1099.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

Questions about this trial

What is this clinical trial studying?

An observational study of Acute HIT II (Heparin-induced Thrombocytopenia Type II), run by GlaxoSmithKline.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Feb 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II (time frame: 19 January 2005 to 25 October 2009). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01304238, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2017.