Activated Factor Seven in Traumatic Retro Peritoneal Hematoma

NCT04424563 | Completed FDA Drug

• 1 other identifier: ICU-8-20
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• stop bleeding

  efficacy of activated factor seven with aminocaproic acid in medical treatment of retroperitoneal bleeding,

  2 days

Study Arms (2)

Group A

Patients of group A include 40 patients, 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.

Device: ventilators; Drug: aminocaproic acid

Group B

While patients of group B include 40 patients, 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.

Device: ventilators; Drug: Novo Seven

Interventions

ventilators DEVICE

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

Group A; Group B

aminocaproic acid DRUG

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

Also known as: Amicar

Group A

Novo Seven DRUG

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

Also known as: activated factor seven

Group B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• severe bleeding

You may not qualify if:

• post arrest

Sponsors & Collaborators

• King Abdul Aziz Specialist Hospital: lead

Study Sites (1)

King abd el Aziz specialist hospital

Ta'if, 21944, Saudi Arabia

Location

MeSH Terms

Interventions

Ventilators, Mechanical; Aminocaproic Acid; recombinant FVIIa

Intervention Hierarchy (Ancestors)

Equipment and Supplies; Aminocaproates; Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2020
• First Posted: June 11, 2020
• Study Start: May 5, 2017
• Primary Completion: December 19, 2019
• Study Completion: December 30, 2019
• Last Updated: June 11, 2020

Record last verified: 2019-12

Locations

SA (1)