Trial Outcomes & Findings for Clinical Management of Argatroban in Patients With Heparin Induced Thrombocytopenia Type II (NCT NCT00861692)
NCT ID: NCT00861692
Last Updated: 2026-01-06
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
During and 30 days after argatroban treatment
Results posted on
2026-01-06
Participant Flow
Participant milestones
| Measure |
Argatroban
start with 1μg/kg/min infusion to be adjusted to aPTT 1.5-3.0 times the baseline values
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Argatroban
start with 1μg/kg/min infusion to be adjusted to aPTT 1.5-3.0 times the baseline values
|
|---|---|
|
Overall Study
Death
|
6
|
Baseline Characteristics
Clinical Management of Argatroban in Patients With Heparin Induced Thrombocytopenia Type II
Baseline characteristics by cohort
| Measure |
Argatroban
n=20 Participants
start with 1μg/kg/min infusion to be adjusted to aPTT 1.5-3.0 times the baseline values
|
|---|---|
|
Age, Continuous
|
71.7 years
STANDARD_DEVIATION 10.4 • n=37 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=37 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=37 Participants
|
PRIMARY outcome
Timeframe: During and 30 days after argatroban treatmentOutcome measures
| Measure |
Argatroban
n=20 Participants
start with 1μg/kg/min infusion to be adjusted to aPTT 1.5-3.0 times the baseline values
|
|---|---|
|
Composite of All-cause Death, Thrombosis (New and Extended) and Unplanned Amputation
|
10 participants
|
PRIMARY outcome
Timeframe: During and 30 days after argatroban treatmentOutcome measures
| Measure |
Argatroban
n=20 Participants
start with 1μg/kg/min infusion to be adjusted to aPTT 1.5-3.0 times the baseline values
|
|---|---|
|
All-cause Death
|
6 participants
|
PRIMARY outcome
Timeframe: During and 30 days after argatroban treatmentOutcome measures
| Measure |
Argatroban
n=20 Participants
start with 1μg/kg/min infusion to be adjusted to aPTT 1.5-3.0 times the baseline values
|
|---|---|
|
Death Related to Heparin-induced Thrombocytopenia (HIT)
|
0 participants
|
PRIMARY outcome
Timeframe: During and 30 days after argatroban treatmentOutcome measures
| Measure |
Argatroban
n=20 Participants
start with 1μg/kg/min infusion to be adjusted to aPTT 1.5-3.0 times the baseline values
|
|---|---|
|
Number of Patients With Thrombosis (New and Extended)
|
5 participants
|
PRIMARY outcome
Timeframe: During and 30 days after argatroban treatmentOutcome measures
| Measure |
Argatroban
n=20 Participants
start with 1μg/kg/min infusion to be adjusted to aPTT 1.5-3.0 times the baseline values
|
|---|---|
|
Number of Patients With Unplanned Amputation
|
0 participants
|
PRIMARY outcome
Timeframe: During and 30 days after argatroban treatmentMajor bleeding is defined as i) overt and associated with a fall in the haemoglobin level 2 g/dl or more, ii) leads to transfusion of 2 units or more, iii) is retroperitoneal, iv) occurs into a major prosthetic joint, or v) in intracranial. Minor bleeding is defined as overt bleeding that does not meet the criteria of major bleeding.
Outcome measures
| Measure |
Argatroban
n=20 Participants
start with 1μg/kg/min infusion to be adjusted to aPTT 1.5-3.0 times the baseline values
|
|---|---|
|
Number of Patients With Major or Minor Bleeding
|
4 participants
|
PRIMARY outcome
Timeframe: Day 3Population: Data are missing in 3 patients.
Platelet increase of ≥ 100G/L or 50%.
Outcome measures
| Measure |
Argatroban
n=17 Participants
start with 1μg/kg/min infusion to be adjusted to aPTT 1.5-3.0 times the baseline values
|
|---|---|
|
Number of Patients With Platelet Count Recovery
|
12 participants
|
Adverse Events
Argatroban
Serious events: 14 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Argatroban
n=20 participants at risk
start with 1μg/kg/min infusion to be adjusted to aPTT 1.5-3.0 times the baseline values
|
|---|---|
|
Blood and lymphatic system disorders
DISSEMINATED INTRAVASCULAR COAGULATION
|
5.0%
1/20
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
5.0%
1/20
|
|
Cardiac disorders
ACUTE CORONARY SYNDROME
|
5.0%
1/20
|
|
Cardiac disorders
CARDIAC ARREST
|
5.0%
1/20
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
5.0%
1/20
|
|
Cardiac disorders
CARDIOGENIC SHOCK
|
5.0%
1/20
|
|
Cardiac disorders
MYOCARDIAL RUPTURE
|
5.0%
1/20
|
|
Gastrointestinal disorders
PERITONITIS
|
10.0%
2/20
|
|
Gastrointestinal disorders
COLITIS
|
5.0%
1/20
|
|
Gastrointestinal disorders
HAEMATEMESIS
|
5.0%
1/20
|
|
Gastrointestinal disorders
PNEUMATOSIS INTESTINALIS
|
5.0%
1/20
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
5.0%
1/20
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
5.0%
1/20
|
|
General disorders
MULTI-ORGAN FAILURE
|
5.0%
1/20
|
|
Infections and infestations
SEPSIS
|
15.0%
3/20
|
|
Infections and infestations
SEPTIC SHOCK
|
5.0%
1/20
|
|
Injury, poisoning and procedural complications
MEDICATION ERROR
|
5.0%
1/20
|
|
Renal and urinary disorders
ACUTE PRERENAL FAILURE
|
5.0%
1/20
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY DISTRESS SYNDROME
|
10.0%
2/20
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
5.0%
1/20
|
|
Respiratory, thoracic and mediastinal disorders
LUNG DISORDER
|
5.0%
1/20
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
5.0%
1/20
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
5.0%
1/20
|
|
Skin and subcutaneous tissue disorders
RASH ERYTHEMATOUS
|
5.0%
1/20
|
|
Vascular disorders
BLUE TOE SYNDROME
|
5.0%
1/20
|
|
Vascular disorders
FEMORAL ARTERY EMBOLISM
|
5.0%
1/20
|
|
Vascular disorders
HAEMORRHAGE
|
5.0%
1/20
|
|
Vascular disorders
JUGULAR VEIN THROMBOSIS
|
5.0%
1/20
|
|
Vascular disorders
PELVIC VENOUS THROMBOSIS
|
5.0%
1/20
|
|
Vascular disorders
PERIPHERAL ISCHAEMIA
|
5.0%
1/20
|
Other adverse events
| Measure |
Argatroban
n=20 participants at risk
start with 1μg/kg/min infusion to be adjusted to aPTT 1.5-3.0 times the baseline values
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
35.0%
7/20
|
|
Blood and lymphatic system disorders
Coagulopathy
|
5.0%
1/20
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.0%
1/20
|
|
Blood and lymphatic system disorders
Pancytopenia
|
5.0%
1/20
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.0%
1/20
|
|
Cardiac disorders
Atrial Fibrillation
|
15.0%
3/20
|
|
Cardiac disorders
Bradycardia
|
10.0%
2/20
|
|
Cardiac disorders
Mitral Valve Incompetence
|
5.0%
1/20
|
|
Cardiac disorders
Tachycardia
|
5.0%
1/20
|
|
Gastrointestinal disorders
Abdominal Pain
|
10.0%
2/20
|
|
Gastrointestinal disorders
Colonic Polyp
|
5.0%
1/20
|
|
Gastrointestinal disorders
Constipation
|
25.0%
5/20
|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
1/20
|
|
Gastrointestinal disorders
Haemorrhoids
|
5.0%
1/20
|
|
Gastrointestinal disorders
Ileus
|
5.0%
1/20
|
|
Gastrointestinal disorders
Impaired Gastric Emptying
|
5.0%
1/20
|
|
Gastrointestinal disorders
Melaena
|
5.0%
1/20
|
|
Gastrointestinal disorders
Mouth Haemorrhage
|
5.0%
1/20
|
|
Gastrointestinal disorders
Nausea
|
10.0%
2/20
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
5.0%
1/20
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
2/20
|
|
General disorders
Asthenia
|
10.0%
2/20
|
|
General disorders
Chest Pain
|
5.0%
1/20
|
|
General disorders
Generalised Oedema
|
5.0%
1/20
|
|
General disorders
Hyperthermia
|
10.0%
2/20
|
|
General disorders
Inflammation
|
10.0%
2/20
|
|
General disorders
Injection Site Inflammation
|
5.0%
1/20
|
|
General disorders
Malaise
|
5.0%
1/20
|
|
General disorders
Oedema Peripheral
|
10.0%
2/20
|
|
General disorders
Pain
|
20.0%
4/20
|
|
General disorders
Puncture Site Haemorrhage
|
5.0%
1/20
|
|
General disorders
Pyrexia
|
20.0%
4/20
|
|
Hepatobiliary disorders
Cholestasis
|
10.0%
2/20
|
|
Hepatobiliary disorders
Hepatic Function Abnormal
|
5.0%
1/20
|
|
Hepatobiliary disorders
Jaundice
|
5.0%
1/20
|
|
Hepatobiliary disorders
Jaundice Cholestatic
|
5.0%
1/20
|
|
Hepatobiliary disorders
Liver Disorder
|
5.0%
1/20
|
|
Immune system disorders
Hypogammaglobulinaemia
|
5.0%
1/20
|
|
Infections and infestations
Device Related Infection
|
20.0%
4/20
|
|
Infections and infestations
Escherichia Urinary Tract Infection
|
10.0%
2/20
|
|
Infections and infestations
Fungal Infection
|
5.0%
1/20
|
|
Infections and infestations
Fungal Sepsis
|
5.0%
1/20
|
|
Infections and infestations
Gastroenteritis
|
5.0%
1/20
|
|
Infections and infestations
Infection
|
5.0%
1/20
|
|
Infections and infestations
Lung Infection
|
5.0%
1/20
|
|
Infections and infestations
Pneumonia
|
10.0%
2/20
|
|
Infections and infestations
Postoperative Wound Infection
|
5.0%
1/20
|
|
Infections and infestations
Sepsis
|
5.0%
1/20
|
|
Infections and infestations
Sinusitis
|
5.0%
1/20
|
|
Infections and infestations
Urinary Tract Infection
|
5.0%
1/20
|
|
Injury, poisoning and procedural complications
Haemodialysis Complication
|
5.0%
1/20
|
|
Injury, poisoning and procedural complications
Incision Site Pain
|
5.0%
1/20
|
|
Injury, poisoning and procedural complications
Overdose
|
15.0%
3/20
|
|
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
|
5.0%
1/20
|
|
Injury, poisoning and procedural complications
Postoperative Wound Complication
|
5.0%
1/20
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
5.0%
1/20
|
|
Investigations
Alpha Globulin Increased
|
5.0%
1/20
|
|
Investigations
Blood Pressure Decreased
|
5.0%
1/20
|
|
Investigations
Coagulation Time Prolonged
|
10.0%
2/20
|
|
Investigations
Cytomegalovirus Test Positive
|
5.0%
1/20
|
|
Investigations
Globulins Decreased
|
5.0%
1/20
|
|
Investigations
Glomerular Filtration Rate Increased
|
5.0%
1/20
|
|
Investigations
Haemoglobin Decreased
|
10.0%
2/20
|
|
Investigations
International Normalised Ratio Increased
|
10.0%
2/20
|
|
Investigations
Pulmonary Function Test Decreased
|
10.0%
2/20
|
|
Investigations
Transaminases Increased
|
5.0%
1/20
|
|
Investigations
Weight Decreased
|
10.0%
2/20
|
|
Metabolism and nutrition disorders
Dehydration
|
5.0%
1/20
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
5.0%
1/20
|
|
Metabolism and nutrition disorders
Folate Deficiency
|
10.0%
2/20
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
5.0%
1/20
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
10.0%
2/20
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
10.0%
2/20
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
15.0%
3/20
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
5.0%
1/20
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
10.0%
2/20
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
5.0%
1/20
|
|
Metabolism and nutrition disorders
Vitamin D Deficiency
|
5.0%
1/20
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
10.0%
2/20
|
|
Nervous system disorders
Altered State Of Consciousness
|
5.0%
1/20
|
|
Nervous system disorders
Depressed Level Of Consciousness
|
5.0%
1/20
|
|
Nervous system disorders
Monoparesis
|
5.0%
1/20
|
|
Nervous system disorders
Paraesthesia
|
5.0%
1/20
|
|
Nervous system disorders
Polyneuropathy
|
5.0%
1/20
|
|
Nervous system disorders
Somnolence
|
5.0%
1/20
|
|
Psychiatric disorders
Anxiety
|
5.0%
1/20
|
|
Psychiatric disorders
Confusional State
|
15.0%
3/20
|
|
Psychiatric disorders
Depression
|
15.0%
3/20
|
|
Psychiatric disorders
Insomnia
|
15.0%
3/20
|
|
Psychiatric disorders
Sleep Disorder
|
5.0%
1/20
|
|
Renal and urinary disorders
Calculus Bladder
|
5.0%
1/20
|
|
Renal and urinary disorders
Dysuria
|
5.0%
1/20
|
|
Renal and urinary disorders
Haematuria
|
5.0%
1/20
|
|
Renal and urinary disorders
Renal Failure Acute
|
5.0%
1/20
|
|
Renal and urinary disorders
Renal Impairment
|
5.0%
1/20
|
|
Respiratory, thoracic and mediastinal disorders
Acute Lung Injury
|
5.0%
1/20
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
5.0%
1/20
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial Obstruction
|
5.0%
1/20
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.0%
2/20
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
5.0%
1/20
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
5.0%
1/20
|
|
Respiratory, thoracic and mediastinal disorders
Hypocapnia
|
5.0%
1/20
|
|
Respiratory, thoracic and mediastinal disorders
Hypoventilation
|
5.0%
1/20
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
10.0%
2/20
|
|
Respiratory, thoracic and mediastinal disorders
Lung Disorder
|
5.0%
1/20
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
10.0%
2/20
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
5.0%
1/20
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
5.0%
1/20
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
10.0%
2/20
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Tract Congestion
|
5.0%
1/20
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.0%
1/20
|
|
Skin and subcutaneous tissue disorders
Rash Macular
|
5.0%
1/20
|
|
Skin and subcutaneous tissue disorders
Skin Dystrophy
|
5.0%
1/20
|
|
Vascular disorders
Aortic Arteriosclerosis
|
5.0%
1/20
|
|
Vascular disorders
Deep Vein Thrombosis
|
5.0%
1/20
|
|
Vascular disorders
Haemodynamic Instability
|
15.0%
3/20
|
|
Vascular disorders
Hypertension
|
15.0%
3/20
|
|
Vascular disorders
Hypotension
|
25.0%
5/20
|
|
Vascular disorders
Venous Thrombosis
|
5.0%
1/20
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER