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Activated Factor Seven in Traumatic Retro Peritoneal Hematoma

NCT04424563 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2020-06-11

No results posted yet for this study

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.

Conditions

  • Traumatic Bleeding

Interventions

DEVICE

ventilators

all patients in both groups will be ventilated if shocked and no recordable blood pressure

DRUG

aminocaproic acid

4 gram slowly intravenous infusion over 1 hour and continues slowly intravenous infusion 1 gram/ hour for 8 hours.

DRUG

Novo Seven

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

Sponsors & Collaborators

  • King Abdul Aziz Specialist Hospital

    lead NETWORK

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-05
Primary Completion
2019-12-19
Completion
2019-12-30
FDA Drug
Yes

Countries

  • Saudi Arabia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04424563 on ClinicalTrials.gov