Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04424563 |
| Other study ID # |
ICU-8-20 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 5, 2017 |
| Est. completion date |
December 30, 2019 |
Study information
| Verified date |
December 2019 |
| Source |
King Abdul Aziz Specialist Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
80 patients with traumatic retro-peritoneal hematoma allocated into two groups 40 patients
each. Patients of Group A received aminocaproic acid while patients of group B received
aFVII. Number of packed RBCs given to get target Hb level and time to get this target Hb
level (>10 gm%) recorded as indicators for control bleeding. Blood pressure, pulse, Arterial
blood gasses and urine output recorded as indicator for treatment of hypovolemic shock.
hypoxic index, chest X ray and coagulation profile used as indicator for complication.
Description:
80 patients admitted to King Abdul-Aziz Specialist Hospital in Taif, KSA between May 2017 and
December 2019 with polytrauma and severe retroperitoneal bleeding diagnosed by abdominal
computerized tomography.
King Abdelaziz research and ethical committee approved the project under heading of ethical
approval and heading of human and animal rights along with Helsinki Declaration.
A written consent from the patient or from their 1st degree relative was obtained if patient
intubated. The primary outcome of This study divided into 3 parts. 1st 0ne compare the
ability of both drugs to stop retroperitoneal bleeding efficiently and in shorter time for
these 2 measurable indicators selected in our study the number of packed RBCS needed to
achieve hemoglobin level (Hb) > 10 gm% and the time needed to achieve this target Hb. the 2nd
part indicators divided into clinical indicators (blood pressure, pulse and urine output) and
laboratory indicators [arterial blood gases especially PH, and bicarbonate concentration
(HCO3)]. the 3rd part indicators PT, PTT and Platelets count were used as indicator for DIC
and hypoxic index and chest x ray were used as indicator for TRALI (transfusion related acute
lung injury).
Resuscitation done in all patients in both groups according to hospital protocol by
crystalloid (normal saline), colloids [plasma protein fraction-packed RBCs, fresh frozen
plasma], until achieve satisfactory stable vital data. All laboratory work samples were
collected (CBC complete blood picture, Blood chemistry included liver enzymes and kidney
function tests, Coagulation profile, arterial blood gasses).
Urine output collected hourly. Our study included any patient who received more than 50ml/kg
blood during the first 8hours after admission in order to achieved a hemoglobin level >10
gram %, with platelet count more than 50, 000/mm3 after resuscitation and Their temperature
was more than 36 degree centigrade after warming. Which considered criteria needed to get
maximum effect from aFVII if used intravenously. Patient randomized into 2 groups, 40
patients in each, this done by randomization numbers. Patients of group A received
aminocaproic acid at dose of 4 gram slowly intravenous infusion over 1 hour and continues
slowly intravenous infusion 1 gram/ hour for 8 hours. While patients of group B received
aFVII according to the following protocol, First dose 200 microgram/kg. If patient still
oozing, vital data not stable and/or could not achieve and keep the target Hb (>10 gm%)
another 2 doses of aFVII received each dose 100microgram /kg 1 hour and 3 hours apart from
the initial dose if needed. The exclusion criteria in our study, if patient had cardiac
arrest before giving aFVII, deeply comatose with Glasgow coma scale (GCS) 3/15 and pupil
dilated fixed.
All patient in both groups observed for 48hours and the following indicators recorded.
Indicators for efficacy of stop bleeding (number of packed RBCs needed to keep hemoglobin
level >10 gm% and time needed to reach this target Hb).
Indicators for ability of both drugs to treatment the hemorrhagic shock and restore tissue
perfusion (and this assessed by clinical indicators blood pressure, pulse and urine output
and laboratory indicators as arterial PH and bicarbonate concentration ( HCO3) Indicators for
ability of both drugs to protect the patients with retroperitoneal hematoma from
complications of massive blood transfusion and in this 2 complications were selected the
disseminated intra-vascular coagulopathy (DIC) and PT, PTT, Platelets count were used as
indicators and (TRALI) transfusion related acute lung injury and the hypoxic index and chest
x ray were used as indicators. The duration of the study only two days and the data recorded
every 8 hours.
