A Phase 4 interventional study of rThrombin, 1000 IU/mL in Blood Loss, Surgical, sponsored by ZymoGenetics. Completed at 1 site in United States. Open to participants aged Up to 17 Years. Per ClinicalTrials.gov, last updated 2012-01-26.
Sponsored by ZymoGenetics · Phase 4, Interventional, and Treatment
The objective of this study is to assess the safety and immunogenicity of recombinant thrombin (rThrombin) administered as an aid to hemostasis during burn wound excision and skin grafting in pediatric patients, newborn through 17 years of age.
The safety, immunogenicity, and efficacy of rThrombin have been evaluated in 5 Phase 2 studies, 1 pivotal Phase 3 study, and 1 Phase 3b study, in surgical indications such as: spinal surgery, major hepatic resection, peripheral arterial bypass surgery, arteriovenous graft formation for hemodialysis access, and burn wound excision. Limited data currently exist on the effects of rThrombin exposure in pediatric patients. This Phase 4 trial aims to provide additional information on the use of rThrombin in children by evaluating the drug's safety and immunogenicity when administered as an aid to hemostasis during burn wound excision and skin grafting in pediatric burn patients.
218 studies on the registry are indexed under Blood Loss, Surgical; 40 are open to participants now.
This study's enrollment of 30 is below the median of 90 across 157 interventional studies indexed under Blood Loss, Surgical.
Browse Blood Loss, Surgical studies →ZymoGenetics is the lead sponsor of 10 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Biological: rThrombin, 1000 IU/mL
rThrombin,1000 IU/mL, 1000 IU/mL, applied topically to the bleeding site during a single surgery procedure on Day 1.
Also known as: RECOTHROM
Number of Participants With Death, Serious Adverse Events, Treatment-related Adverse Events (AE), AEs Leading to Discontinuation, and AEs of Hypersensitivity
An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=possibly, probably, or certainly related to and of unknown relationship to study treatment
Time frame: Days 1 through 29, continuously
Number of Participants With AEs by Maximum Severity
An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. Mild=asymptomatic or minor symptoms; intervention not indicated. Moderate=requiring only minimal, local, or noninvasive intervention. Severe=significant symptoms but not life-threatening; hospitalization or invasive intervention indicated. Life-threatening=indicating intensive care or urgent invasive intervention.
Time frame: Days 1 through 29, continuously
Number of Participants With Clinical Laboratory Findings of Grade O or Higher in Platelet, White Blood Cell (WBC), Lymphocyte, and Neutrophil Counts
Abnormal laboratory findings were recorded as AEs when considered clinically significant (unusual for the surgical population or individual participant) by the investigator, when associated with symptoms, when requiring specific treatment, or when requiring a change in participant management.LLN=lower level of normal. Platelets: Grade 0=normal. WBC: Grade 0=normal. Lymphocytes: Grade 0=normal; Grade 1=\<LLN x 0.8-10\^9/L. Neutrophils: Grade 0=normal; Grade 1=\<LLN-1.5x10\^9/L; Grade 2=\<1.5-1.0x10\^9/L
Time frame: Baseline and Day 29 from Baseline
Number of Participants With Clinical Laboratory Findings of Grade 0 or Higher in Hemoglobin Levels
LLN=lower level of normal. Grade 1=100 g/L to \<LLN; Grade 2=80 to \<100 g/L; Grade 3=65 to \<80 g/L; Grade 4=\<65 g/L.
Time frame: Baseline and Day 29 from Baseline
Number of Participants With Clinical Laboratory Findings of Grade 0 or Higher in Creatinine Levels
ULN=upper level of normal. Grade 0=normal; Grade 1=\>ULN to 1.5 x ULN.
Time frame: Baseline and Day 29 from Baseline
Number of Participants With Elevations in the Coagulation Parameter of Activated Partial Thromboplastin Time (aPPT)of Grade 0 or Higher
ULN=upper limit of normal. Grade 0=normal; Grade 1=ULN to 1.5 x ULN.
Time frame: Baseline and Day 29 from Baseline
Number of Participants With a High International Normalized Ratio (INR) of Prothrombin Time of Grade 0 or Higher
Grade 0=normal.
Time frame: Baseline and Day 29 from Baseline
Number of Participants WIth Positive Findings for Anti-rThrombin Product Antibody
Antibody-positive was defined as seroconversion or ≥1.0 unit (≥10-fold) increase in titer compared with antibody titer at baseline.
Time frame: At Day 29
Of the 32 participants who signed informed consent in this study, 30 were actually enrolled and received treatment with rThrombin.
| Milestone | rThrombin, 1000 IU/mL |
|---|---|
| Started | 30 |
| Completed | 28 |
| Not completed | 2 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Parent withdrew consent | 1 |
An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=possibly, probably, or certainly related to and of unknown relationship to study treatment
| Participants | rThrombin, 1000 IU/mL |
|---|---|
| Deaths | 0 |
| Serious adverse events | 1 |
| Treatment-related adverse events (AEs) | 0 |
| AEs leading to discontinuation | 0 |
| AEs of hypersensitivity | 3 |
An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. Mild=asymptomatic or minor symptoms; intervention not indicated. Moderate=requiring only minimal, local, or noninvasive intervention. Severe=significant symptoms but not life-threatening; hospitalization or invasive intervention indicated. Life-threatening=indicating intensive care or urgent invasive intervention.
| Participants | rThrombin, 1000 IU/mL |
|---|---|
| Mild (0-2 years, n=11) | 3 |
| Mild (3-6 years, n=8) | 3 |
| Mild (7-11 years, n=3) | 0 |
| Mild (12-17 years, n=8) | 3 |
| Moderate (0-2 years, n=11) | 1 |
| Moderate (3-6 years, n=8) | 5 |
| Moderate (7-11 years, n=3) | 3 |
| Moderate (12-17 years, n=8) | 3 |
| Severe (0-2 years, n=11) | 3 |
| Severe (3-6 years, n=8) | 0 |
| Severe (7-11 years, n=3) | 0 |
| Severe (12-17 years, n=8) | 1 |
| Life-threatening (0-2 years, n=11) | 3 |
| Life-threatening (3-6 years, n=8) | 0 |
| Life-threatening (7-11 years, n=3) | 0 |
| Life-threatening (12-17 years, n=8) | 0 |
Antibody-positive was defined as seroconversion or ≥1.0 unit (≥10-fold) increase in titer compared with antibody titer at baseline.
| Participants | rThrombin, 1000 IU/mL |
|---|---|
| Number of Participants WIth Positive Findings for Anti-rThrombin Product Antibody | 0 |
Abnormal laboratory findings were recorded as AEs when considered clinically significant (unusual for the surgical population or individual participant) by the investigator, when associated with symptoms, when requiring specific treatment, or when requiring a change in participant management.LLN=lower level of normal. Platelets: Grade 0=normal. WBC: Grade 0=normal. Lymphocytes: Grade 0=normal; Grade 1=\<LLN x 0.8-10\^9/L. Neutrophils: Grade 0=normal; Grade 1=\<LLN-1.5x10\^9/L; Grade 2=\<1.5-1.0x10\^9/L
| Participants | rThrombin, 1000 IU/mL |
|---|---|
| Grade 0, low platelets (Baseline) | 30 |
| Grade 0, low platelets (Day 29, N=25) | 25 |
| Grade 0, low WBC (Baseline) | 30 |
| Grade 0, low WBC (Day 29, N=26) | 26 |
| Grade 0, low lymphocytes (Baseline, N=29) | 28 |
| Grade 0, low lymphocytes (Day 29, N=25) | 25 |
| Grade 1, low lymphocytes (Baseline, N=29) | 1 |
| Grade 1, low lymphocytes (Day 29, N=25) | 0 |
| Grade 0, neutrophils (Baseline, N=29) | 29 |
| Grade 0, neutrophils (Day 29, N=25) | 24 |
| Grade 2, low neutrophils (Baseline) | 0 |
| Grade 2, low neutrophils (Day 29, N=25) | 1 |
LLN=lower level of normal. Grade 1=100 g/L to \<LLN; Grade 2=80 to \<100 g/L; Grade 3=65 to \<80 g/L; Grade 4=\<65 g/L.
| Participants | rThrombin, 1000 IU/mL |
|---|---|
| Grade 1 low hemoglobin (Baseline) | 13 |
| Grade 1 low hemoglobin (Day 29, N=26) | 7 |
| Grade 2 low hemoglobin (Baseline) | 4 |
| Grade 2 low hemoglobin (Day 29, N=26) | 5 |
| Grade 3 low hemoglobin (Baseline) | 1 |
| Grade 3 low hemoglobin (Day 29, N=26) | 0 |
| Grade 4 low hemoglobin (Baseline) | 0 |
| Grade 4 low hemoglobin (Day 29, N=26) | 0 |
ULN=upper level of normal. Grade 0=normal; Grade 1=\>ULN to 1.5 x ULN.
| Participants | rThrombin, 1000 IU/mL |
|---|---|
| Grade 0 high creatinine (Baseline, N=30) | 30 |
| Grade 0 high creatinine (Day 29, N=26) | 25 |
| Grade 1 high creatinine (Baseline) | 0 |
| Grade 1 high creatinine (Day 29, N=26) | 1 |
ULN=upper limit of normal. Grade 0=normal; Grade 1=ULN to 1.5 x ULN.
| Participants | rThrombin, 1000 IU/mL |
|---|---|
| Grade 0 high aPPT (Baseline, N=29) | 22 |
| Grade 0 high aPPT (Day 29, N=24) | 19 |
| Grade 1 high aPPT (Baseline, N=29) | 7 |
| Grade 1 high aPPT (Day 29, N=24) | 5 |
Grade 0=normal.
| Participants | rThrombin, 1000 IU/mL |
|---|---|
| Grade 0 INR High (Baseline, N=28) | 28 |
| Grade 0 INR High (Day 29, N=24) | 24 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| TOTAL | — | 1/30 (3.3%) | 28/30 (93.3%) |
| Event | TOTAL |
|---|---|
| TRANSPLANT REJECTIONImmune system disorders | 1/30 |
| SKIN GRAFT INFECTIONInfections and infestations | 1/30 |
| Event | TOTAL |
|---|---|
| PROCEDURAL PAINInjury, poisoning and procedural complications | 15/30 |
| PRURITUSSkin and subcutaneous tissue disorders | 13/30 |
| ANAEMIABlood and lymphatic system disorders | 9/30 |
| PYREXIAGeneral disorders | 3/30 |
| TRANSPLANT REJECTIONImmune system disorders | 3/30 |
| CONSTIPATIONGastrointestinal disorders | 2/30 |
| VOMITINGGastrointestinal disorders | 2/30 |
| OEDEMA PERIPHERALGeneral disorders | 2/30 |
| BACTERAEMIAInfections and infestations | 2/30 |
| SKIN GRAFT INFECTIONInfections and infestations | 2/30 |
| Age, Customized(participants) | rThrombin, 1000 IU/mL |
|---|---|
| 0-2 years | 11 |
| 3-6 years | 8 |
| 7-11 years | 3 |
| 12-17 years | 8 |
| Sex: Female, Male(Participants) | rThrombin, 1000 IU/mL |
|---|---|
| Female | 12 |
| Male | 18 |
| Race/Ethnicity, Customized(participants) | rThrombin, 1000 IU/mL |
|---|---|
| American Indian/Alaskan native | 1 |
| Black or African American | 6 |
| Hispanic | 9 |
| White | 14 |
This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.
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