Intracerebral Hemorrhage
Conditions
Keywords
intracerebral hemorrhage, platelets
Brief summary
The investigators intend to show that DDAVP improves platelet activity from baseline to 60 minutes after treatment start.
Interventions
DRUGDDAVP injection (desmopressin acetate)
0.4 mcg/kg in 250 mL NS intravenously once over 30 minutes
Sponsors
Northwestern Memorial Hospital
Northwestern University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Spontaneous intracerebral hemorrhage as documented by head CT scan * Documented regular aspirin use or VerifyNow-ASA result of ≤ 550 aspirin reaction units (ARU), indicating anti-platelet medication
Exclusion criteria
* International normalized ratio (INR) of ≥ 1.7 from coagulopathy or warfarin use * History of von Willebrand disease * Pregnancy * Known hypersensitivity to DDAVP or desmopressin * Active cardiovascular disease or unstable angina * Hyponatremia or history of hyponatremia * Current or historical deep venous thrombosis or pulmonary embolism
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Platelet Activity, Measured in Seconds on PFA-EPI Assay, From Pre to Post-treatment | 60 minutes after treatment start | The Platelet Function Analyzer (PFA) is a commercially available point-of-care assay that measures the time to closure of an aperature. Longer time to closure indicates less platelet activity. EPI denotes epinephrine (as opposed to adenosine diphosphate) as the stimulant to platelet aggregation. In our laboratory, a time to closure of at least 172 seconds in consistent with an aspirin effect. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events : New Fever >=100.4F, Respiratory Distress or Pulmonary Edema on Chest Radiography, Rash, Hypotension (Systolic BP < 100 mm Hg or New Vasopressor Use or Increase in Vasopressor Dose by >25%) | within 6 hours of study treatment | We prospectively defined acute adverse events as: new fever \>=100.4F, respiratory distress or pulmonary edema on chest radiography, rash, hypotension (systolic BP \< 100 mm Hg or new vasopressor use or increase in vasopressor dose by \>25%). The two patients reported were the only two that sustained any of the prospectively defined adverse events. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DDAVP DDAVP 0.4 mcg/kg intravenously in 250 mL NS over 30 minutes
DDAVP injection (desmopressin acetate): 0.4 mcg/kg in 250 mL NS intravenously once over 30 minutes | 14 |
| Total | 14 |
Baseline characteristics
| Characteristic | DDAVP |
|---|---|
| Age, Continuous | 66.8 years STANDARD_DEVIATION 14.6 |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 14 |
| serious Total, serious adverse events | 2 / 14 |
Outcome results
Primary
Change in Platelet Activity, Measured in Seconds on PFA-EPI Assay, From Pre to Post-treatment
The Platelet Function Analyzer (PFA) is a commercially available point-of-care assay that measures the time to closure of an aperature. Longer time to closure indicates less platelet activity. EPI denotes epinephrine (as opposed to adenosine diphosphate) as the stimulant to platelet aggregation. In our laboratory, a time to closure of at least 172 seconds in consistent with an aspirin effect.
Time frame: 60 minutes after treatment start
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DDAVP | Change in Platelet Activity, Measured in Seconds on PFA-EPI Assay, From Pre to Post-treatment | 68 seconds | Standard Error 24.1 |
Comparison: We tested the hypothesis that there would be a change from baseline to 60 minutes after the start of the desmopressin (DDAVP) infusion.p-value: 0.014t-test, 2 sided
Secondary
Adverse Events : New Fever >=100.4F, Respiratory Distress or Pulmonary Edema on Chest Radiography, Rash, Hypotension (Systolic BP < 100 mm Hg or New Vasopressor Use or Increase in Vasopressor Dose by >25%)
We prospectively defined acute adverse events as: new fever \>=100.4F, respiratory distress or pulmonary edema on chest radiography, rash, hypotension (systolic BP \< 100 mm Hg or new vasopressor use or increase in vasopressor dose by \>25%). The two patients reported were the only two that sustained any of the prospectively defined adverse events.
Time frame: within 6 hours of study treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DDAVP | Adverse Events : New Fever >=100.4F, Respiratory Distress or Pulmonary Edema on Chest Radiography, Rash, Hypotension (Systolic BP < 100 mm Hg or New Vasopressor Use or Increase in Vasopressor Dose by >25%) | 2 participants |